Smf Update SOLITAIRE

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TITLE: Site Master File TITLE: Site Master File Document No.

Document No. EEFFFFEECCTTIIVVE E DDAATTEE NNEEXXT T RREEVVIIEEW W DDAATTEE PPAAGGE NE Noo.. S

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 1 1 oof f 3355

SITE MASTER FILE

OF

SOLITAIRE PHARMACIA PVT.LTD

..

PLOT N

PLOT NO.25O.25 Ext -Ext -11 HPSIDC HPSIDC AREA AREA BADDI BADDI DISTTDISTT SOLAN HIMACHAL PRADESH-173205 SOLAN HIMACHAL PRADESH-173205

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TITLE: Index TITLE: Index Document No.

Document No. EEFFFFEECCTTIIVVE E DDAATTEE NNEEXXT T RREEVVIIEEW W DDAATTEE PPAAGGE NE Noo.. S SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 2 2 oof f 3355 S Srr..NNoo TTiittllee PPaaggee NNoo.. 1 1 CCoovveerrPPaaggee 0011 2 2 IInnddeexx 0022 3

3 GGeenneerraall DDeettaaiill 0033

4

_{Plant Location}

04&0504&05

5

5 GGeenneerraal l IInnffoorrmmaattiioonn 06&0706&07 6

6

_{Process Approach}

08&0908&09

7

7 PPeerrssoonnaall 1010 To To 1212

8

8 PPrreemmiisseess 1133 TToo 1155

9

9 VVeennttiillaattiioon n ssyysstteem m & & UUttiilliittiieess 1166 TTo o 1199 1

100 EEqquuiippmmeennttss 20 To 2520 To 25 1

111 SSaanniittaattiioonn & & DDooccuummeennttaattiioonn 26 & 2726 & 27 1

122 PPrroodduuccttiioonn 28 & 2928 & 29 1

133 QQuuaalliitty y CCoonnttrrooll 30 To 3230 To 32 14

14 DiDiststriribubutitionon, C, Comomplplaiaintnts as and nd PrPrododucuct Rt Rececalalll 3333 1

155 SSeellf f IInnssppeeccttiioonn 3434 1 166 QQuuaalliitty y ppoolliiccyy 3535 REVISION INDEX REVISION INDEX Sr. Sr. No. No. D Daattee DDooccuummeenntt No. No. C Chhaanngge e DDeettaaiillss CChheecckkeedd By By

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TITLE: General Detail TITLE: General Detail Document No.

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 3 3 oof f 3355

General Detail General Detail

3.

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Plot No.

Plot No. 25 Ext-1

25 Ext-1 HPSIDC

HPSIDC Area,

Area,

Baddi, Tehsil Nalagarh ,

Dist solan.(H.P) -173 205.

Tel.: 09815777744

E-mail :

E-mail : [email protected]

[email protected]

: [email protected]

33..44

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PLOT NO. 73,INDUSTRIAL AREA, PLOT NO. 73,INDUSTRIAL AREA, PHASE

PHASE II, II, CHANDIGARH.CHANDIGARH.

Tel.:

Tel.: 0172-5000477,5000

0172-5000477,5000478

478 Fax:

Fax:

5000477,2653293

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TITLE: Site Location Plan TITLE: Site Location Plan D

Dooccuummeennt t NNoo. . EEFFFFEECCTTIIVVE E DDAATTEE NNEEXXT T RREEVVIIEEW W DDAATTEE PPAAGGE E NNoo.. S SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 4 4 of of 3355 A A M M Annexure:4.1 Annexure:4.1 A A R R A A R RooaaddNNoo..33 VV A A T T Plot no.19 Plot no.19 SOLITAIRE SOLITAIRE PHARMACIA PHARMACIA PVT. LTD. PVT. LTD. PPlloott nnoo.. II Plot no.25 Plot no.25 P

Plloot t nnoo2266.. PPlloot t nnoo..

Plot no 27 Plot no 27 R R P Plloott nnoo.. OO P Plloott nnoo..1188 AA D D P

Plloot t nnoo..2288 PPlloot t nnoo..

P

Plloot t nnoo..2299 PPlloot t nnoo.. R

Rooaadd RRooaadd RRooaadd Spray Eng.

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NALAGARH NALAGARH

TITLE: Site Location Plan TITLE: Site Location Plan D

Dooccuummeennt t NNoo. . EEFFFFEECCTTIIVVE E DDAATTEE NNEEXXT T RREEVVIEIEW W DDAATTEE PPAAGGE E NNoo.. S

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 5 5 oof f 3355

DRAW SCATCH OF PLANT LOCATION

FROM RAILWAY STATION

PINJOR PINJOR I I G G A A R R H H KALKA KALKA RAILWAY RAILWAY STATION STATION Solitaire Solitaire Pharmacia Pharmacia Pvt. Ltd Pvt. Ltd.. S S H H I I M M L L A A BADDI BADDI BADDI BADDI BUS STOP BUS STOP Amaravati Amaravati Appt.

Appt. N.R.I N.R.I Hospital Hospital

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TITLE: General Information TITLE: General Information Document No.

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 66 oof f 3355

5.0

5.0 GENERAL GENERAL INFORMATIONINFORMATION

INTRODUCTION:

SOLITAIRE PHARMACIA PVT LTD., a Baddi (H.P.) based

SOLITAIRE PHARMACIA PVT LTD., a Baddi (H.P.) based company established by Mr.Sanjeev

company established by Mr.Sanjeev

Kumar Sethi, who has deep knowledge and vast experience of pharmaceutical business .He has

now ventured in setting up state of the

now ventured in setting up state of the art pharma manufacturing facility of WHO,cGMP

art pharma manufacturing facility of WHO,cGMP

standards

..

LOCATION

:-The plant is located at Baddi

The plant is located at Baddi (Himachal Pradesh) in well connected industrial belt at a

(Himachal Pradesh) in well connected industrial belt at a distance of

distance of

40 kms from C

40 kms from Chandigarh on Pinj

handigarh on Pinjore –

ore – Nalagarh Highway

Nalagarh Highway and is engaged in

and is engaged in the manufacturing of

the manufacturing of

solid dosage forms. The location is well connected with roads & railway station i

solid dosage forms. The location is well connected with roads & railway station is about 20 kms at

s about 20 kms at

Kalka

Kalka.

.

The plant is located on 997

The plant is located on 997 square meter plot. The factory is cons

square meter plot. The factory is constructed and designed to meet the

tructed and designed to meet the

WHO, cGMP standards in consultation with highly

WHO, cGMP standards in consultation with highly qualified and experienced technical

qualified and experienced technical

personnel’s approved by FDA for manufacturing and testing. The

personnel’s approved by FDA for manufacturing and testing. The plant has AHU systems i.e.,

plant has AHU systems i.e., Air

Air

conditioning and Control humidity for all

conditioning and Control humidity for all manufacturing departments to avoid cross

manufacturing departments to avoid cross

contamination

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has established a modern facility as per GMP standards to

manufacture

manufacture tablets

tablets (Non

(Non ß-Lactam)

ß-Lactam) &

& Hormonal

Hormonal tablets

tablets . . The

The unit

unit is

is managed

managed by

by experienced

experienced

technical staff for production & quality control along with a t

technical staff for production & quality control along with a team of expert technicians.

eam of expert technicians.

The company has a pharmaceutical formulation plant located on the Ground floor for hormonal

product & first floor for Non ß-Lactam respectively

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SALIENT FEATURES SALIENT FEATURES

SOLITAIRE PHARMACIA PVT LTD. has observed and will practice the SOLITAIRE PHARMACIA PVT LTD. has observed and will practice the

following:-Factory designed and constructed as per GMP

Factory designed and constructed as per GMP specification.specification. Code of ethics in production and quality.

Code of ethics in production and quality. Training to the personnel as per

Training to the personnel as per new guidelines.new guidelines. Electrification is done for easy energy audit. Electrification is done for easy energy audit. Illumination level 300

Illumination level 300 lux inlux in all manufacturing all manufacturing areas.areas. Water proofing of entire terrace slab.

Water proofing of entire terrace slab.

HPLC. UV-spectrophotometer under one roof. HPLC. UV-spectrophotometer under one roof.

Pre-Construction Anti-Termite Pest Control treatment for entire factory building Pre-Construction Anti-Termite Pest Control treatment for entire factory building

The company has full fledged Quality Assurance, Purchase, Store, Production, Administration The company has full fledged Quality Assurance, Purchase, Store, Production, Administration Engineering

Engineering Dept., Dept., headed headed by by very very experienced experienced personnel’s.personnel’s.

All standard operating procedure (work instruction) related with above production process are

available with QA department & individual department.

Facilities & list of equipment are available in site master file.

List of

List of Proposed

Proposed products an

products and other tech

d other technical details a

nical details are available in

re available in site master

site master file.

file.

Plant is fully equipped with:

5.1 5.1 Exhaustive pest

Exhaustive pest control system

control system to ensure tota

to ensure total freedom from

l freedom from insects and ro

insects and rodents.

dents.

5.2 5.2 Wall, floor

Wall, floor and ceiling

and ceiling painted, free

painted, free from crack,

from crack, dust and

dust and dirt.

dirt.

5.3 5.3 Full Fledged water sys

Full Fledged water system i.e.(a) Raw water system

tem i.e.(a) Raw water system equipped with sand

equipped with sand filter to ensure

filter to ensure

free

free from

from Insoluble

Insoluble and g

and gaseous

aseous impurities (b)

impurities (b) R.O

R.O water

water plant fo

plant for Pu

r Purified water

rified water

Core team of HOD’s

Core team of HOD’s of Quality assurance/Quality Control, Engineering, Production & Adm.

of Quality assurance/Quality Control, Engineering, Production & Adm.

Working under Managing Director ensures effective quality system, planning and

Implementation.

TITLE: General Information TITLE: General Information Document No.

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TYPE OF PRODUCTS

TYPE OF PRODUCTS LICENSED FOR MANUFACTURE WITH FLOWCHARTLICENSED FOR MANUFACTURE WITH FLOWCHART MENTIONING PROCEDU

MENTIONING PROCEDURE AND RE AND PROCESS FLOW :PROCESS FLOW : (i)

(i)

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manufacturemanufactures wide range s wide range of pharmaceuticals formulations inof pharmaceuticals formulations in General Categories of General Tablet & Hormonal tablets as per the approved Product List General Categories of General Tablet & Hormonal tablets as per the approved Product List enclosed

enclosed

((iiii)) FFoor pr prroocceesss fs flloow & w & pprroocceedduurre fe flloow cw chhaarrt at as ps peer fr foolllloowwiinngg..

Tablets

Q

Q..AA..--22 QQ..AA--11

Q. Q.A. A. -- 44 Q.A.-3 Q.A.-3 Q. Q.A.A.-- 44 S

Saammpplliinng g --- TTeessttiinngg Q

QAA11 --- WWaatteer r ccoonntteenntt, , BBuullk k ddeennssiittyy

Q.

Q.A.A.-- 55 QAQA2 2 --- WeWeigight ht vavaririatatioion, n, ApAppepeararanancece, , CoCololour ur

Shape, D.T, Hardness, Friability Shape, D.T, Hardness, Friability Q

QAA3 3 --- DD..TT. . AAppppeeaarraannccee Q

QAA44 --- DD..TT, , AAppppeeaarraannccee, , PPaatthhooggeen n aanndd Q

QAA55 --- IIn n pprroocceesss s llaabbeelliinngg, , ppaacckkiinng g ddeettaaiillss

Annexure:6.1 Annexure:6.1

TITLE: Process Approach TITLE: Process Approach Document No.

Document No. EEFFFFEECCTTIIVVE E DDAATTEE NNEEXXT T RREEVVIIEEW DW DAATTEE PPAAGGE E NNoo.. S SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 8 8 oof f 3355 Tablet packing Tablet packing Coating Coating Visual

Visual Inspection Inspection CompressionCompression LubricationLubrication Sizing / MillingSizing / Milling

Final Release Final Release Visual Inspection

Visual Inspection Weighting

Weighting SievingSieving MixingMixing Wet or dryWet or dry Granulation

Granulation DryingDrying

Dispatch Dispatch Final Release Final Release Tablet packing Tablet packing

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has facility to carry out Chemical Physico-chemical, Instrumentalhas facility to carry out Chemical Physico-chemical, Instrumental Analysis

Analysis

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takes assistance from outside institution for testing its samplestakes assistance from outside institution for testing its samples Samples are sent for getting testing done where sophisticated instruments like

Samples are sent for getting testing done where sophisticated instruments like IR, GC & Bio-IR, GC & Bio-Assay

Assay are required.are required. ..

PROCESS APPROACH:

PROCESS APPROACH: _{there will be}_{there will be basically four type}_{basically four type of process in}_{of process in the organization}_{the organization}

a. Core process (customer related process) a. Core process (customer related process)

b. Management process (process carried out by top management /MR) b. Management process (process carried out by top management /MR) c. Supporting process (process to help core /management process) c. Supporting process (process to help core /management process) d. Work process (process flow as per individual department wise d. Work process (process flow as per individual department wise

Annexure:6.1 Annexure:6.1

TITLE: Process Approach TITLE: Process Approach Document No.

Document No. EEFFFFEECCTTIIVVE E DDAATTEE NNEEXXT T RREEVVIIEEW DW DAATTEE PPAAGGE E NNoo.. S SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 9 9 oof f 3355 Management Management Process Process

Quality Policy & Quality Policy & Quality Objective Quality Objective (Business Plan) (Business Plan) Budgeting Budgeting (Resource Plan) (Resource Plan) Resource Resource Allotment Allotment Management Management Review / Audit Review / Audit Core Core Process Process Marketing Marketing Customer Customer Order Order Customer Customer Satisfaction Satisfaction Production / Production / Service Service Planning Planning Dispatch Dispatch Production Production Material / Production Material / Production / Service / testing / Service / testing Material service Material service procurement / procurement / storage storage

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TITLE: Personnel TITLE: Personnel Document No.

Document No. EEFFFFEECCTTIIVVE E DDAATTEE NNEEXXT T RREEVVIIEEW DW DAATTEE PPAAGGE E NNoo.. S

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 110 0 oof f 3355

7.0 PERSONNEL 7.0 PERSONNEL (a)

(a)ORGANISATIONAL CHART ORGANISATIONAL CHART SHOWING THE SHOWING THE ARRANGEMENTS FOR ARRANGEMENTS FOR QUALITY QUALITY ASSURANCE ASSURANCE INCLUDINGINCLUDING PRODUCTION & QUALITY CONTROL

PRODUCTION & QUALITY CONTROL ::

HIERACHICAL CHART HIERACHICAL CHART

Managing Director

Plant Head

Q.C In Charge

Q.A In Charge /Q.A In Charge /

Management Management Re Re reresesentntatativivee

Production

In Charge

Engineering

In Charge

Store In Charge

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SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 111 1 oof f 3355

(b)

(b) QUALIFICATION, EXPERIENCQUALIFICATION, EXPERIENCE & RESPONSIBILITIES E & RESPONSIBILITIES OF KEY PERSONNEL :OF KEY PERSONNEL :

Sr. Sr. No. No.

N

Naamme e oof f PPeerrssoonn QQuuaalliiffiiccaattiioon n EExxppeerriieennccee DDeeppaarrttmmeenntt AApppprroovvaal l // Unapproved Unapproved (A

(A)) MAMANUNUFAFACTCTURURINING G SESECTCTIOIONN 1

1 MMrr. . RRaajjeesshh Makanwal Makanwal

B

B..PPhhaarrmm 88 yyrrss MMffgg. . SSeeccttiioonn AApppprroovveedd 2

2 MMr r RRaam m llaall Prajapati Prajapati

B

B..SScc.. 1188 yyrrss MMffgg. . SSeeccttiioonn AApppprroovveedd (B

(B)) QUQUALALITITY CY CONONTRTROL OL SESECTCTIOIONN 3 3 MMrrss. . JJaahhaannvvi i RRaaoo MM..SScc.. 1166 yyrrss CChheemmiiccaal l aanndd Physicochemical Physicochemical Section Section Approved Approved

Number of employees to be engaged in production, quality control, storage and Number of employees to be engaged in production, quality control, storage and distribution.

distribution.

P

Prroodduuccttiioon n DDeepptt.. :: 1010 Q

Quuaalliitty y ccoonnttrrool l & & AAssssuurraanncce e DDeepptt.. :: 0066 S

Sttoorre e ( ( RRMM, , PM PM & & FFGG)) :: 0044 P

P&& AADDeepptt.. :: 0033 M

Maaiinntteennaanncce e DDeepptt.. :: 0033 A

AccccoouunnttDDeepptt.. :: 0022

T

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SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 112 2 oof f 3355 (c)

(c) OUTLINE FOR ARRANGEMENT FOR BASIC AND IN SERVICE TRAINING AND HOWOUTLINE FOR ARRANGEMENT FOR BASIC AND IN SERVICE TRAINING AND HOW RECORDS ARE MAINTAINED :

RECORDS ARE MAINTAINED : All employee

All employees will have to go through training as per annual training plan. Trainings will have to go through training as per annual training plan. Training on GMP will beon GMP will be on-going pro

on-going process and all the employecess and all the employees will bees will be regularly trainregularly trained to increase their awareneed to increase their awareness of ss of current requirements. Immediate outside experts & superior impart through training for all current requirements. Immediate outside experts & superior impart through training for all departmenta

departmental. The employees are subjected to oral l. The employees are subjected to oral & written & written quarries. The training records will bequarries. The training records will be maintained for all employees.

maintained for all employees. (d)

(d) HEALTH REQUIREMENT FOR PERSONNEL ENGAGED IN PRODUCTION :HEALTH REQUIREMENT FOR PERSONNEL ENGAGED IN PRODUCTION : 

 Administrative head is responsible for arranging the medical checking of employeesAdministrative head is responsible for arranging the medical checking of employees through a qualified physician.

through a qualified physician. 

 Medical examination is carried out by company approved physician every year or inMedical examination is carried out by company approved physician every year or in between if required.

between if required. 

 For any unusual findings during the check up physician advises the person affected.For any unusual findings during the check up physician advises the person affected. During the treatment period suitable reallocation of job is done. Rechecking is done During the treatment period suitable reallocation of job is done. Rechecking is done following approved guidance & frequently, and after the person is certified medically fit, following approved guidance & frequently, and after the person is certified medically fit, he is put on his original job.

he is put on his original job. (e)

(e) PERSONNEL HYGINE REQUIRMENTS, INCLUDING CLOTHING :PERSONNEL HYGINE REQUIRMENTS, INCLUDING CLOTHING : 

 The company provides change rooms for changing company uniforms including shoes.The company provides change rooms for changing company uniforms including shoes. 

 The employees working in production area change their shoes and wear factoryThe employees working in production area change their shoes and wear factory footwear, along with factory uniforms & cap.

footwear, along with factory uniforms & cap. 

 The employees in other areas like Quality control will wear aprons and laboratoryThe employees in other areas like Quality control will wear aprons and laboratory slippers. The employees in engineering department wear suitable shoes and factory slippers. The employees in engineering department wear suitable shoes and factory uniforms.

uniforms. 

 All the employees have been instructed about dress code and to change the dressAll the employees have been instructed about dress code and to change the dress every other day.

every other day. 

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TITLE: Premises TITLE: Premises Document No.

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 113 3 oof f 3355

8.0 PREMISES 8.0 PREMISES (a)

(a) LAYOUTLAYOUT PLAN PLAN OR DOR DESCRIPTION ESCRIPTION OF MANOF MANUFACUTRING UFACUTRING AREA AREA :: Sr.

Sr. No. No.

A

Arreeaa TTyyppe e oof f aarreea a ffiinniisshhiinngg 1

1.. GGrroouunnd d fflloooorr RRCCC C RRooooff, , KKootta Sa Sttoonne e & & FFlluussh dh doooorrss.. 2

2.. FFiirrsst t fflloooorr RRCCC C RRooooff, , KKootta a SSttoonne e & & FFlluussh h ddoooorrss.. 3

3 SSeeccoonnd d fflloooorr VeVettrriiffiieed d ttiillees s iin n QQ..C C AArreeaa 4

4 SSeerrvviicce e AArreeaa RRCCC C rrooooffs s & & CCoovveerreed d wwiitth h ffaannccy y hhoooodd 3

3.. UUttiilliitty y BBlloocckk RRCCC C FFlloooor r 4

4.. DD..GG..SSeet t AArreeaa RRCCC C FFlloooor r G

Grroouunnd d fflloooorr FFiirrsst t fflloooorr SSeeccoonndd fflloooor r Sr. Sr. No. No. A Arreeaa SSrr.. No. No. A Arreeaa SSrr.. No. No. Area Area 1

1.. MMD D & & AAddmm. . OOffffiiccee 11.. GGeenneerraallPPrroodduuccttiioonn 1..1 IInnccuubbaattoor r 2

2.. WWaarreehhoouussee 22.. GGeenneerraal l PPaacckkiinngg 22.. CChheemmiiccaal l sseeccttiioonn 3

3.. CChhaanngge e rroooomm 33.. AApppprroovveed d RR..M M SSttoorree 33.. ReRettaaiin n ssaammppllee 4

4.. TTooiilleett 4..4 AApppprroovveed d PP..M M SSttoorree 44.. RReeccoorrd d rroooomm 5

5.. RR..MM..SSttoorree 55.. SttaSabbiilliitty y cchhaammbbeer r 6

6 HHoorrmmoonnaallPPrroodduuccttiioon n 66.. QQ..CC..OOffffiiccee 7

7 SSeeccuurriitty y ooffffiiccee 77.. MMiiccrro o tteessttiinngg 8

8 VViissiittoorrs s RRoooommss 88.. MMeeddiia a pprreeppn n RRoooomm 9

9 HHoorrmmoonnaal l PPaacckkiinngg 99.. IInnssttrruummeennt t RRoooomm 1

100 UUttiilliitty By Blloocckk 1

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Canteen & toilet is not

Canteen & toilet is not directly attached with production area. Plant layout design & equipment isdirectly attached with production area. Plant layout design & equipment is as per t

as per the revised schedule-M requirement.he revised schedule-M requirement. (b)

(b) NATURE OF NATURE OF CONSTRUCTION CONSTRUCTION && FIXTURES / FITTINFIXTURES / FITTINGS :GS : 

 Building:Building: The building is made up of RCC construction and all the processing areasThe building is made up of RCC construction and all the processing areas from inside are having smooth wall painted with oil paint/oil bound emulsion paint. from inside are having smooth wall painted with oil paint/oil bound emulsion paint. 

 Utility:Utility: Manufacturing equipments are provided power supply back up with DG set,Manufacturing equipments are provided power supply back up with DG set, which is bale to restore DG power within 2 minutes. The critical QC instruments are also which is bale to restore DG power within 2 minutes. The critical QC instruments are also provided with stabilizer.

provided with stabilizer. 

 Aluminum doors & Windows:Aluminum doors & Windows: The doors and windows are designed very carefully toThe doors and windows are designed very carefully to have a minimum number of horizontal surfaces. The sills of the windows are sloping. have a minimum number of horizontal surfaces. The sills of the windows are sloping. The windows are kept flush with the plaster inside manufacturing areas and gap The windows are kept flush with the plaster inside manufacturing areas and gap between aluminum and masonry are sealed with scaling.

between aluminum and masonry are sealed with scaling. 

 Floor:Floor: Flooring is made up of mirror polished Kota stone.Flooring is made up of mirror polished Kota stone. 

 Coving:Coving: Coving is provided in all production areas at the junctiCoving is provided in all production areas at the junction of wall to on of wall to floor, wall tofloor, wall to wall to ceiling and are painted with washable paint.

wall to ceiling and are painted with washable paint. 

 Fall ceiling:Fall ceiling: Fall ceiling in the air-conditioned areas is of plaster of Fall ceiling in the air-conditioned areas is of plaster of paris sheets. Theparis sheets. The sheets is fixed with doub

sheets is fixed with double layered arrangle layered arrangementement and the joints of the upper layeand the joints of the upper layer andr and lower layer of the board are

lower layer of the board are so arranged (staggered) that there is no leakages of so arranged (staggered) that there is no leakages of air.air. 

 All entrances and major doors are provided with air lock and air curtains wherever All entrances and major doors are provided with air lock and air curtains wherever required.

required. 

 The sanitary fittings are connected and drainage system is under ground and providedThe sanitary fittings are connected and drainage system is under ground and provided with trapped gullies.

with trapped gullies. 

 S.S LightS.S Light 

 S.S-304 riser S.S-304 riser 

 Both Side Stair & Well Both Side Stair & Well EquippedEquipped LiftLift provisionprovision TITLE: Premises TITLE: Premises Document No.

(15)

(d)

(d) SPECIFIAL AREAS FOR THE HANDLING OF HIGHLY TOXIC, SPECIFIAL AREAS FOR THE HANDLING OF HIGHLY TOXIC, HAZARDOUS &HAZARDOUS & SENSITIZING MATERIALS:

SENSITIZING MATERIALS:

Not Applicable, as presently we do not use s

Not Applicable, as presently we do not use s uch type of materials.uch type of materials. (e)

(e) BRIEF DESCRIPTION OF WATER SYSTEMS (schematic drawings of systems) :BRIEF DESCRIPTION OF WATER SYSTEMS (schematic drawings of systems) : Copy attached

Copy attached

Total 4 sampling points are provided for water system

Total 4 sampling points are provided for water system monitoring, cleaninmonitoring, cleaning, sanitation andg, sanitation and validation plan is follow

validation plan is followed as per standard operating procedued as per standard operating procedures, water log bookres, water log book & water & water validation file.

validation file. (f)

(f) DESCRIPTION OF PLANNED PREVENTIVE DESCRIPTION OF PLANNED PREVENTIVE MAINTAINANCE PROGRAMMES FORMAINTAINANCE PROGRAMMES FOR PREMISES AND OF THE RECORDING SYSTEM :

PREMISES AND OF THE RECORDING SYSTEM :

More emphasis is given on the preventive maintenance program of plant utility services, machines More emphasis is given on the preventive maintenance program of plant utility services, machines etc. Maintenance department is equipped with highly qualified and experienced engineers and etc. Maintenance department is equipped with highly qualified and experienced engineers and technicians. Maintenance as well as plant operators are provided through training at machine technicians. Maintenance as well as plant operators are provided through training at machine manufacturin

manufacturing site for g site for knowing its operation, use, accuracy, efficacy etc.knowing its operation, use, accuracy, efficacy etc. Installation qualifica

Installation qualification & tion & performance qualificaperformance qualification of tion of every new machine is every new machine is carried out.carried out. Calibratio

Calibrations are ns are done frequently. The logbooks are done frequently. The logbooks are maintained for all critical equipments.maintained for all critical equipments. Whenever necessa

Whenever necessary, help ry, help of outside maintenance consultants is taken of outside maintenance consultants is taken to maintain facilities suchto maintain facilities such as Air handling units, laminar air flow, pest

as Air handling units, laminar air flow, pest control etc. routines as well as control etc. routines as well as periodical maintenperiodical maintenanceance are scheduled and documented. For recording system

are scheduled and documented. For recording system computer validation system is fcomputer validation system is f ollowedollowed.. TITLE: Premises

TITLE: Premises Document No.

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TITLE:VENTILATION SYSTEM & UTILITIES TITLE:VENTILATION SYSTEM & UTILITIES Document No.

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 116 6 oof f 3355

S

SRR. . NNOO.. DDEESSCCRRIIPPTTIIOONN

1

1 AIR HANDLING UNITSAIR HANDLING UNITS

HOREMON-Gr

HOREMON-Ground ound Floor Floor

AHU-1-40

AHU-1-4000CFM-65mm-00CFM-65mm- 8TR[Grenu8TR[Grenulation]lation] AHU-2-60

AHU-2-600CFM-65mm-0CFM-65mm- 1.5 TR[Samplin1.5 TR[Sampling/Dispensing/Dispensing]g] AHU-3-60

AHU-3-600CFM-65mm-0CFM-65mm- 1.5 1.5 TR[TIB]TR[TIB]

AHU-4-1200CFM-65mm-3TR[Blister Pack] AHU-4-1200CFM-65mm-3TR[Blister Pack] AHU-5-800CFM-65mm-2TR[Strip Pack] AHU-5-800CFM-65mm-2TR[Strip Pack] AHU-6-800CFM-65mm-2TR[Compression] AHU-6-800CFM-65mm-2TR[Compression] AHU-7-12

AHU-7-1200CFM-65mm-00CFM-65mm- 3TR[Coating3TR[Coating]] AHU-8-32

AHU-8-3200CFM-65mm-00CFM-65mm- 6TR[Corrido6TR[Corridor & Miscr & Misc.].] AHU-9-600CFM-65mm-1.5TR[Sampling]

AHU-9-600CFM-65mm-1.5TR[Sampling] AHU-10-80

AHU-10-800CFM-65mm-0CFM-65mm- 2TR[Blendin2TR[Blending]g] AHU-11-60

AHU-11-600CFM-65mm-0CFM-65mm- 1.5TR[Sampli1.5TR[Sampling]ng]

General Tablets-First Floor

AHU-12-4800CFM-65mm-10TR[Granulation] AHU-12-4800CFM-65mm-10TR[Granulation] AHU-13-1200CFM-65mm-3TR[Blending] AHU-13-1200CFM-65mm-3TR[Blending] AHU-14-12

AHU-14-1200CFM-65m00CFM-65mm-m- 3TR[Coating3TR[Coating-1]-1] AHU-15-12

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AHU-16-80

AHU-16-800CFM-65mm-0CFM-65mm- 2TR[Compres2TR[Compression-2]sion-2] AHU-17-60

AHU-17-600CFM-65mm-0CFM-65mm- 1.5TR 1.5TR [TIB][TIB] AHU-18-60

AHU-18-600CFM-65mm-0CFM-65mm- 1.5TR[Dispen1.5TR[Dispensing]sing] AHU-19-1200CFM-65mm-3TR[Blister-1] AHU-19-1200CFM-65mm-3TR[Blister-1] AHU-20-1200CFM-65mm-3TR[Blister-2] AHU-20-1200CFM-65mm-3TR[Blister-2] AHU-21-80

AHU-21-800CFM-65mm-0CFM-65mm- 2TR[Strip 2TR[Strip PackingPacking]] AHU-22-32

AHU-22-3200CFM-65m00CFM-65mm-6TR[Corridm-6TR[Corridor or & & Misc.]Misc.] AHU-23-12

AHU-23-1200CFM-65m00CFM-65mm-m- 3TR[Coating3TR[Coating-2]-2]

Quality Control-Second Floor Quality Control-Second Floor AHU-24-60

AHU-24-600CFM-65mm-0CFM-65mm-1.5TR[ 1.5TR[ Micro Micro Q.C.]Q.C.]

2

2 Forcd Draft Ventillation Forcd Draft Ventillation Supply Air System[GROUND FLOOR]Supply Air System[GROUND FLOOR]

FDVS-1:2000-20[Gen.Ch.Room] FDVS-1:2000-20[Gen.Ch.Room] FDVS-2:1000-50[Hormon Ch.Room] FDVS-2:1000-50[Hormon Ch.Room] FDVS-3:1000-20[Hormon PMS] FDVS-3:1000-20[Hormon PMS] FDVS-4:1000-20[General PMS] FDVS-4:1000-20[General PMS] FDVS-5:300

FDVS-5:3000-20[Misc. 0-20[Misc. Q.C.Area]Q.C.Area]

3

3 Forcd Draft Ventillation Forcd Draft Ventillation Exhaust Air System[GROUND FLOOR]Exhaust Air System[GROUND FLOOR]

FDVE-1:100

FDVE-1:1000-20[Gen.Ch.R0-20[Gen.Ch.Room-First oom-First floor]floor] [Not Require as Room Exhaust-Hormon] [Not Require as Room Exhaust-Hormon]

(18)

4

4 Refrigeration Type DehumidifireRefrigeration Type Dehumidifire

1 TR 1 TR 2 TR 2 TR

OTHE

OTHERRUTILIUTILITIES[TIES[GROUGROUND ND FLOORFLOOR]]

5

5 AAiir r CCoommpprreessssoorr--11 Air Compressor-2 Air Compressor-2

6

6 CCoommpprreesssseed d AAiir r DDrryyeer r

7 7 DD..M M WWaatteer r PPllaanntt 8 8 DD..M M WWaatteer r PPllaanntt 9 9 EETTPP Split A.C

Split A.C Misc. Stores[GROUND FLOOR]Misc. Stores[GROUND FLOOR]

R.M.Approved Store R.M.Approved Store Horemone F.P.S Horemone F.P.S

Secondary Packing Hall Secondary Packing Hall General FP Stores General FP Stores Director's Office Director's Office Reception Reception

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Manager Office Manager Office Staff Office Staff Office

Split

Split RM Stores[FIRST FLOOR]RM Stores[FIRST FLOOR]

A.C

A.C Approved RM[14a]Approved RM[14a] ALU.PVC Store[14b] ALU.PVC Store[14b]

Split A.C

Split A.C Misc. Areas[SECOND FLOOR]Misc. Areas[SECOND FLOOR] Q.C.Manager

Q.C.Manager

Critical Instrument Room Critical Instrument Room General Instrument Room General Instrument Room Retain Sample Room Retain Sample Room

Minimum 20 air changes are provided in all production area, supply filter are having 5

Minimum 20 air changes are provided in all production area, supply filter are having 5porosity & return filter areporosity & return filter are having 20

having 20porosity. Minimum 0.5mm pressure difference is kept in different categories of production area withporosity. Minimum 0.5mm pressure difference is kept in different categories of production area with maximum positive pressure kept in filling & sealing area. Refer plan layout Annexure 1 for more details.

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TITLE: Equipment TITLE: Equipment Document No.

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 220 0 oof f 3355 4.0 EQUIPMENT

4.0 EQUIPMENT (a)

(a) BRIEF DESCRIPTION OF MAJOR EQIPMENT USED IN BRIEF DESCRIPTION OF MAJOR EQIPMENT USED IN PRODUCTION & CONTROLPRODUCTION & CONTROL LABORATORIES : LABORATORIES : General Tablets General Tablets NAME OF NAME OF MACHINE MACHINE S

SUUPPPPLLIIEERR CCAAPPAACCIITTYY EELLEE.. LOAD LOAD H.P H.P AIR AIR Q QTTYY((CCFFMM)) PPRREESSSSUURREE((K K G) G) FLUID BED FLUID BED DRIER DRIER T TEECCHHXX 6600 KKGG 1414..00 110000 66..00kkgg V VIIBBRRO O SSIIFFTTEERR TETECCHHXX 3366”” 11..00 R R..MM..GG TTEECCHHXX 115500LLTTRR 2288..00 1100 66..00kkgg P PAASSTTE E KKEETTTTLLEE TTEECCHHXX 11000 0 LLTTRR 55..00 M MUULLTTIIMMIILLLL TTEECCHHXX 22550 0 KKGG//HHRR 33..00 LUBRICATION LUBRICATION OCTAGONAL OCTAGONAL BLENDER BLENDER T TEECCHHXX 33000 0 LLTTRR 33..00 COATING-1 COATING-1 C COOAATTIINNG G PPAANN TETECCHHXX 3366”” 77..00 SOLUTION SOLUTION PREPARATION PREPARATION TANK TANK T TEECCHHXX 550 0 LLTTRR 00..77 C COOLLLLOOIID D MMIILLLL TTEECCHHXX 33..00 COATING-2 COATING-2 C COOAATTIINNG G PPAANN TETECCHHXX 3366”” 77..00 COMPRESSION COMPRESSION A ACCRRAA--BB44--2277--DD FFLLUUIIDDPPAACCKK 227 7 SSTTN N ((D D – – TOOLING) TOOLING) 5 .0 5 .0 A ACCRRAA--BB44--2277--DD FFLLUUIIDDPPAACCKK 227 7 SSTTN N ((D D – – TOOLING) TOOLING) 5 .0 5 .0 DUST DUST FFLLUUIIDDPPAACCKK 11550 0 CCFFMM 11..550 0 115500

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DUST DUST EXTRACTOT-2 EXTRACTOT-2 F FLLUUIIDDPPAACCKK 11550 0 CCFFMM 11..550 0 115500 DE-BURRING&DED BURRING&DED USTING UNIT 4 USTING UNIT 4 NO. NO. F.P F.P MACHINERIES MACHINERIES 2.0 2.0 PACKING PACKING B BLLIISSTTEERR KKUULLBBIINNDDRRAA 99..00 115500 66..00kkgg A ALLUU--AALLUU PP..GG 99..00 115500 55..00kkgg CONVEYOR CONVEYOR BELT-1 BELT-1 1.0 1.0 CONVEYOR CONVEYOR BELT-2 BELT-2 1.0 1.0 HORMONAL SECTION HORMONAL SECTION GRANULATION SECTION GRANULATION SECTION FLUID BED FLUID BED DRIER DRIER T TEECCHHXX 110 0 KKGG 88..00 V VIIBBRRO O SSIIFFTTEERR TETECCHHXX 1122”” 00..55 R R..MM..GG TTEECCHHXX 225 5 LLTTRR 55..00 M MUULLTTIIMMIILLLL TTEECCHHXX 22..00 LUBRICATION LUBRICATION OCTAGONAL OCTAGONAL BLENDER BLENDER T TEECCHHXX 550 0 LLTTRR 11..55 COATING-1 COATING-1 C COOAATTIINNG G PPAANN TETECCHHXX 2244”” 55..00 SOLUTION SOLUTION PREPARATION PREPARATION TANK TANK T TEECCHHXX 550 0 LLTTRR 00..77 COMPRESSION COMPRESSION A ACCRRAA--BB44--2277--DD FFLLUUIIDDPPAACCKK 227 7 SSTTN N ((DD – – TOOLING TOOLING 5.0 5.0 DE-BURRING&DED BURRING&DED USTING UNIT 4 USTING UNIT 4 NO. NO. F.P F.P MACHINERIES MACHINERIES 1.0 1.0 DUST DUST EXTRACTOR-1 EXTRACTOR-1 F FLLUUIIDDPPAACCKK 11550 0 CCFFMM PACKING PACKING B BLLIISSTTEERR KKUULLBBIINNDDRRAA 88..8800 115500 44..0 0 kkgg S STTRRIIPP KKUULLBBIINNDDRRAA 33..55

(22)

AIR AIR COMPRESSOR COMPRESSOR K KAAIILLA A EENNGGIINN 1100..00 A

AIIR R DDRRIIEERR KKAAIILLA A EENNGGIINN 22..00 R R..OO..PPLLAANNTT AARRYYAATTEECCHH 11000000 LTR/HR LTR/HR 7.0 7.0 E E..TT..P P PPLLAANNTT MAMAIINNSSA A EENNGGGG.. WORKS WORKS 3000-5000 3000-5000 LTR LTR 7.0 7.0 A A..HH..U U DDYYNNAAFFLLOOWW 225500..00

(23)

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 223 3 oof f 3355

S

SRR..NNOO.. NNAAMME E MMAAKKE E MMOODDEEL L NNOO,, SSPPEECCIIFFIICCAATTIIOONN 1

1 HHPPLLCC WWaatteerrss 551155 Isocratic systemIsocratic system 2

2 UV UV spspecectrtropophohototomemeteter r SShhiimmaaddzzuu UUVV--11880000 Std.Std. 3

3 AnAnalalyytiticcal Bal Balalananccee 4

4 ppH H mmeetteer r 5

5 AbAbbe be rerefrfracactotomemeteter r 6

6 PPoollaarriimmeetteer r 7

7 KKF F aappppaarraattuuss 8

8 UUV cV caabbiinneett 9

9 MeMeltilting pong point int appappararatuatus(s(didigitgital)al) 10

10 PotPotententiomiometeter/er/AuAutottotititratrator or

CHEMICA

CHEMICAL

L SECTION

SECTION

SR.NO. SR.NO.

NAME OF LABORATORY NAME OF LABORATORY

IINNSSTTRR.. MMAAKKE E MMOODDEEL L NNOO,, SSPPEECCIIFFIICCAATTIIOONN 1

1 VVaaccccuum om ovveenn 2

2 SSoonniiccaattoor r 3

3 MeMechchananicical al flflak ak shshakaker er 4

4 WWaatteer r bbaatthh 5

5 UUninivveerrssaal ol ovveenn 6

6 MMuufffflle e ffuurrnanaccee 7

7 HHeaeattining g mmananttlele 8

8 HoHot pt plalate te wiwith th ststirirrerer r 9

9

Dist. Water app. (wall Dist. Water app. (wall mounted)s.s

mounted)s.s 1

100 TTLLC C kkiitt 11

11 BulBulk dek densnsitity appy appa.(a.(TaTappipping tyng type)pe) 12

12 DisDissosolutlution ion tetest ast appappa. 8 b. 8 basaskeketsts 13

13 LeLeak ak tetesst at appppa.a. 14 14 Friability appa.(digital rpm Friability appa.(digital rpm counter) counter)

(24)

SR.NO. SR.NO.

NAME OF LABORATORY NAME OF LABORATORY

IINNSSTTRR.. MMAAKKE E MMOODDEEL L NNOO,, SSPPEECCIIFFIICCAATTIIOONN 1

1 MMiiccrroossccooppee 2

2 AAuuttooccllaavvee 3

3 BacBacterterioliologiogicacal l inincucubatbator or 4

4 BBOOD iD innccuubbaattoor r 5

5 CoCololony cny couountnterer(d(digigititalal)) 6

6 LLaammiinnaar r AAiir r FFlloow w bbeenncchh PPooppuullaarr HHoorriizzoonnttaall

(b)

(b) DESCRIPTION OF PLANNED PREVENTIVE MAINTAINANCE PROGRAMS FORDESCRIPTION OF PLANNED PREVENTIVE MAINTAINANCE PROGRAMS FOR EQUIPMENT & OF THE RECORDING SYSTEM :

EQUIPMENT & OF THE RECORDING SYSTEM :

As mentioned in point planned preventive maintenance exists and the records are maintained for As mentioned in point planned preventive maintenance exists and the records are maintained for preventive maintenance and major breakdown of equipment and machine.

preventive maintenance and major breakdown of equipment and machine. (c)

(c) QUALIFICATION & CALIBRATION INCLUDING THE RECORDING SYSTEM ANDQUALIFICATION & CALIBRATION INCLUDING THE RECORDING SYSTEM AND ARRANGEMEN

ARRANGEMENT FOR T FOR COMPUTERIZED SYSTEMS VALIDATION :COMPUTERIZED SYSTEMS VALIDATION : Periodic calibratio

Periodic calibration / n / validation of equipments / process / Utilities / validation of equipments / process / Utilities / system / personnel are carriedsystem / personnel are carried out and records are maintained. For certain equipments and utilities validation is carried out

out and records are maintained. For certain equipments and utilities validation is carried out

periodically by the standard external agencies. Calibration / validation schedule protocol is as per periodically by the standard external agencies. Calibration / validation schedule protocol is as per calibration / validation Index

calibration / validation Index .. It is

It is audited in self-inspection.audited in self-inspection.

Written standard operating procedures are laid for cleaning of manufacturing areas and Written standard operating procedures are laid for cleaning of manufacturing areas and equipmen

equipments. For ts. For area cleaning two type area cleaning two type disinfectants are used fortnightly alternatively. Review of disinfectants are used fortnightly alternatively. Review of standard operating proced

standard operating procedure is made at ure is made at every three years and any correction / every three years and any correction / deviation isdeviation is properly recorded after getting authorizatio

properly recorded after getting authorization from Q.A. n from Q.A. as per procedure of document & as per procedure of document & datadata control.

control.

Pest control of the entire plant is maintained through administration department with the help of Pest control of the entire plant is maintained through administration department with the help of outside agencies.

(25)

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 225 5 oof f 3355 List of Calibration of Equipments /

List of Calibration of Equipments / InstrumentsInstruments S

Srr..NNoo.. IItteemm FFrreeqquueennccy y oof f CCaalliibbrraattiioonn// Validation

Validation 1

1 PPeesst t CCoonnttrrooll YYeeaarrllyy 2

2 MMeeddiiccaal l CChheecckkuup op of f EEmmppllooyyeeee YYeeaarrllyy 3

3 AAsseeppttiic c FFiilllliinng g ((MMeeddiia a FFiilll l tteesstt)) YeYeaarrllyy 4

4 FFiilltteer r IInntteeggrriitty y TTeessttiinngg BBaattcch h wwiissee 5

5 MMaannuuffaaccttuurriinng g ttaannkk At At tthhe e ttiimme e oof f ppuurrcchhaassee 6

6 ppHH MMeetteerr DDaaiillyy 7

7 SSiinngglle e PPaan n BBaallaannccee DDaaiillyy/ / YYeeaarrllyy 8

8 PPllaatte e ffoorrm m BBaallaannccee DDaaiillyy/ / YYeeaarrllyy 9

9 SSppeeccttrroopphhoottoommeetteerr MMoonntthhllyy 1

100 AAuutto o ccllaavvee DDaaiillyy//QQuuaarrtteerrllyy 1

111 DDrry y hheeaat t sstteerriilliizzeerr DDaaiillyy//QQuuaarrtteerrllyy 1

122 AAsseeppttiic c AArreeaa DDaaiillyy 1

133 UU..VV. . LLiigghhtt QQuuaarrtteerrllyy 1

144 TThheerrmmoommeetteerr AAt t tthhe e ttiimme e oof f uussee 1

155 GGllaasss s eeqquuiippmmeenntt At At tthhe e ttiimme e oof f ppuurrcchhaassee 1

166 NNoorrmmaalliitty y TTeessttiinngg AAt t tthhe e ttiimme e oof f uussee 1

177 PPrreessssuurree//TTeemmpp..ggaauuggeess//HHyyggrroommeetteerr YYeeaarrllyy 1

188 HHeeppa a ffiilltteerrss YYeeaarrllyy 1

199 PPrroodduucct t SSttaabbiilliitty y ssttuuddiieess AAs s ppeer r iinnddiivviidduuaal l pprroodduucctt 2

200 IInntteer r DDeeppaarrttmmeennt t AAuuddiitt QQuuaarrtteerrllyy 2

211 MMeleltitinng g ppooinint t ApApppararatatuus s MonMonththlyly 2

(26)

TITLE: Sanitation /

TITLE: Sanitation / DocumentationDocumentation Document No.

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 226 6 oof f 3355

11.0 SANITATION 11.0 SANITATION (a)

(a) AVAILABILITY OF WRITTEN SPECIFICATION & PROCEDURE FOR CLEANINGAVAILABILITY OF WRITTEN SPECIFICATION & PROCEDURE FOR CLEANING MANUFACTURING AREA & EQUIPMENT :

MANUFACTURING AREA & EQUIPMENT :

Sanitation of entire plant, surrounding and manufacturing area

Sanitation of entire plant, surrounding and manufacturing area is being done as per is being done as per area cleaningarea cleaning SOP’s

SOP’s

Efficacy of Disinfectant solutions is validated microbiologically. Efficacy of Disinfectant solutions is validated microbiologically.

HVAC system & water system is also continuously sanitized and the same is recorded in utility HVAC system & water system is also continuously sanitized and the same is recorded in utility logbook.

logbook.

Validation of the equ

Validation of the equipment cleaning will beipment cleaning will be done as per done as per master validation plan.master validation plan.

11

11.A.A DODOCUCUMEMENTNTATATIOIONN (a)

(a) ARRANGEMENARRANGEMENT FOR THE T FOR THE PREPARATION, REVISION & DISTRIBUTION OFPREPARATION, REVISION & DISTRIBUTION OF

NECESSARY DOCUMENTATION FOR MANUFACTURE: NECESSARY DOCUMENTATION FOR MANUFACTURE:

a.

a. WelWell-l-dedefinfined ed syssystem tem exiexists sts for for in in warwardiding, ng, stostoragrage e and and ississue ue of of raw raw & & pacpackinkingg materials.

materials. b.

b. RaRaww & p& packackining mg mateateriarials ls are are samsamplpled ed and and appapprovroved ed by by QuaQualitlity Cy Contontrol rol depdepartartmement.nt. c.

c. BatBatch ch manmanufaufactucturinring rg recoecords rds (BM(BMR) R) for for eveevery ry proproduduct act and nd eveevery bry batcatch ih is iss issuesued bd byy quality assurance to

quality assurance to production department.production department. d.

d. In In proprocescess chs checkecks as at ret regulgular ar intintervervals als are are carcarrieried od outut witwith ph proproper er docdocumumententatiation on by by Q.AQ.A.. e.

e. All All manmanufaufactucturinring opg operaeratiotion is n is folfollowlowed ed as pas per ier insnstrutructictions ons givgiven ien in BMn BMR anR and end entaitaill heads before submission to Q.A. for f

heads before submission to Q.A. for final approval of the batch.inal approval of the batch. f.

f. BefBefore ore finfinal al disdispapatch tch of of eveevery ry babatchtch, Qu, Qualiality ty assuassuranrance ce dedeparpartmetment nt ververifiifies es BMR BMR aloalongng with certificate of analysis and release slip is

with certificate of analysis and release slip is issued.issued.

Solitair

Solitaire Pharmacia Pvt. Ltd.e Pharmacia Pvt. Ltd. maintaimaintains documents regardingns documents regarding:: 

 Standard Operating Procedure & its related records.Standard Operating Procedure & its related records. 

 Site Master fileSite Master file 

 Specification of all Materials & Finish productsSpecification of all Materials & Finish products 

 Test procedure & protocolTest procedure & protocol 

 Master formula cardMaster formula card 

 Batch production & control recordsBatch production & control records 

 Disposal recordsDisposal records 

 Release records & distribution recordsRelease records & distribution records 

 Calibration / Validation recordsCalibration / Validation records



(27)

TITLE:

TITLE: SANITATIONSANITATION & & DocumentationDocumentation Document No.

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 227 7 oof f 3355

Standard operating procedure are prepared for each and every operation and are authorized Standard operating procedure are prepared for each and every operation and are authorized for all the

for all the departmental activitiedepartmental activities and strictly followed.s and strictly followed.

All minor changes in the documents are recorded in the same records by recalling copies from All minor changes in the documents are recorded in the same records by recalling copies from all departments for authorization by QA head with date

all departments for authorization by QA head with date of correction. For major changes entireof correction. For major changes entire documents are replaced with ame

documents are replaced with amendment copy and old copiesndment copy and old copies are destroyed except one keptare destroyed except one kept with QA

with QA department with cancellation.department with cancellation. A detail of documents withd

A detail of documents withdrawal / distribution wrawal / distribution will beill be kept with QA departmenkept with QA department under t under document and data control index.

document and data control index. Necessary docum

Necessary document related to manufacent related to manufacturing such as Master formulturing such as Master formulaa card and Batchcard and Batch manufacturing & its associated record

manufacturing & its associated record are maintained and issued by are maintained and issued by Q.A.departmenQ.A.department.t. (b)

(b) ANY COPY OTHER DOCUMENTS RELATED TO PRODUCT QUALITY THAT IS NOTANY COPY OTHER DOCUMENTS RELATED TO PRODUCT QUALITY THAT IS NOT MENTIONED ELSEWHERE :

MENTIONED ELSEWHERE :

(E.G. MICROBIOLOGICAL CONTROLS IN AIR &

(E.G. MICROBIOLOGICAL CONTROLS IN AIR & WATER)WATER) Following methods are followed as per well-defined schedule: Following methods are followed as per well-defined schedule:



 Microbial counts and limit tests for bore Microbial counts and limit tests for bore well, DM water and finished products.well, DM water and finished products. 

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TITLE: Production TITLE: Production Document No.

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 228 8 oof f 3355 7.0 PRODUCTION

7.0 PRODUCTION (a)

(a) BRIEF DESCRIPTION OF PRODUCTION OPERATIONS :BRIEF DESCRIPTION OF PRODUCTION OPERATIONS :

Production operation is explained by way of flow chart describing movement of material & Production operation is explained by way of flow chart describing movement of material & movement of batch manufacturing record. Refer

movement of batch manufacturing record. Refer Annexure 6.1Annexure 6.1 attached.attached. (b)

(b) ARRANGEMENARRANGEMENTS FOR THE TS FOR THE HANDLING OF STARTING OF STARTINGHANDLING OF STARTING OF STARTING MATERIALS,

MATERIALS, PACKAGING MPACKAGING MATERIALS ATERIALS && BULK & BULK & FINISHED FINISHED PRODUCTS PRODUCTS INCLUDINGINCLUDING SAMPLING, QUARANTINE, RELEASE & STORAGE :

SAMPLING, QUARANTINE, RELEASE & STORAGE :

Each consignment of material received is examined visually and damaged goods are kept Each consignment of material received is examined visually and damaged goods are kept separate and inform to quality control person f

separate and inform to quality control person f or further instructions for disposal or return goods toor further instructions for disposal or return goods to party.

party.

On verification of quantity received and making batch wise segregation identification number is On verification of quantity received and making batch wise segregation identification number is given serially.

given serially.

All the containers are labeled “UNDER TEST” with

All the containers are labeled “UNDER TEST” with details such as name, inward number, quantity,details such as name, inward number, quantity, no. of containers, manufacture’s name, material code no. and put material in to the quarantine no. of containers, manufacture’s name, material code no. and put material in to the quarantine area.

area.

Samples are drawn as per sampling plan & tested in detail as per specification by quality control. Samples are drawn as per sampling plan & tested in detail as per specification by quality control. On completion of tests Q.C.

On completion of tests Q.C. decided whether the material is approved or rejected and accordinglydecided whether the material is approved or rejected and accordingly if material is approved, “APPROVED” label are fixed and material is transferred to approve if material is approved, “APPROVED” label are fixed and material is transferred to approve material storage area. If material rejected than transfer to rejected area (Flow chart of Movement material storage area. If material rejected than transfer to rejected area (Flow chart of Movement of material is

of material is enclosed).enclosed).

All packing materials are stored securely under lock & key and issued

All packing materials are stored securely under lock & key and issued in requisite number only. Atin requisite number only. At various places of operation separate areas are created so that the material or product is held on various places of operation separate areas are created so that the material or product is held on “Under Test”, “Approved”, “Rejected” or “Quarantine” area etc.

“Under Test”, “Approved”, “Rejected” or “Quarantine” area etc. All raw materials are tAll raw materials are t ransported inransported in closed labeled containers or properly labeled sealed plastic bags. The Quality Assurance closed labeled containers or properly labeled sealed plastic bags. The Quality Assurance instructions are followed for material status. All weighing balance are regularly calibrated.

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TITLE: Production TITLE: Production Document No.

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 229 9 oof f 3355 (c)

(c) ARRANGEMENTS FOR THE HANDLING ARRANGEMENTS FOR THE HANDLING OF REJECTED MATERIALS & OF REJECTED MATERIALS & PRODUCTS :PRODUCTS : For all rejected materials, the materials are separated from other “Approved” or “Under Test” lots For all rejected materials, the materials are separated from other “Approved” or “Under Test” lots and “Rejected” labels are affixed by the Quality control persons. The rejected material is and “Rejected” labels are affixed by the Quality control persons. The rejected material is transferred to a separate “Rejected materials” area. Quality assurance decides the fate of such transferred to a separate “Rejected materials” area. Quality assurance decides the fate of such rejected materials as to destroy, reprocess or to

rejected materials as to destroy, reprocess or to refer to the supplier.refer to the supplier. (d)

(d) BRIEF DESCRIPTION OF GENERAL POLICY FOR PROCESS VALIDATION :BRIEF DESCRIPTION OF GENERAL POLICY FOR PROCESS VALIDATION :

Process validation is as per documented program (master validation plan), which provides a high Process validation is as per documented program (master validation plan), which provides a high degree of ass

degree of assurance that urance that a specific proa specific process will ccess will consistently proonsistently produce aduce a product meetiproduct meeting it’sng it’s predetermin

predetermined specification and ed specification and quality attributes.quality attributes.

We follow the following systems with regard to process validation: We follow the following systems with regard to process validation:



 Establish specification and performance criteria.Establish specification and performance criteria. 

 Select methodology, process & equipment to ensure the product meets with theSelect methodology, process & equipment to ensure the product meets with the specification.

specification. 

 Test the final product using validated analytical methods in order to Test the final product using validated analytical methods in order to meet specification.meet specification. Following steps supports the above steps:

Following steps supports the above steps: 

 CalibratioCalibration, verification and n, verification and maintenance of process equipments.maintenance of process equipments. 

 Qualification of both process & Qualification of both process & equipment.equipment. 

 ChallengChallenge, audit, monitor or e, audit, monitor or sample the recognized critical or key steps in sample the recognized critical or key steps in the process.the process. 

 And finally when there is a significant change in the product or process,And finally when there is a significant change in the product or process, Re-qualify or revalidate the process.

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TITLE: Quality Control TITLE: Quality Control Document No.

Document No. EEFFFFEECCTTIIVVE E DDAATTEE NNEEXXT T RREEVVIIEEW DW DAATTEE PPAAGGE E NNoo.. S

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 330 0 oof f 3355

SHORT DESCRIPTION OF THE QUALITY MANAGEMENT SYSTEM OF THE FIRM SHORT DESCRIPTION OF THE QUALITY MANAGEMENT SYSTEM OF THE FIRM

The company believes in total quality management system and constantly upgrading standards of The company believes in total quality management system and constantly upgrading standards of specificatio

specification of n of its products & services. The quality policy states its products & services. The quality policy states as under,as under,

We at

We at Solitaire Pharmacia

Solitaire Pharmacia Pvt Ltd

Pvt Ltd are Committed,

are Committed,

To supply Quality medicines at competitive rates & Service to

Satisfy our Customer.

To follow prevailing

To follow prevailing National & International Standards

National & International Standards of Pharmaceutical

of Pharmaceutical

Industry.

To continually improve our

To continually improve our Quality Management System

Quality Management System with

with Continual

Continual

Training & Collective Wisdom.

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TITLE: Quality Control TITLE: Quality Control Document No.

SMMFF//0011//0011 0011..1100..22000099 3300..0099..22001100 331 1 oof f 3355

Quality has been the most prime

Quality has been the most prime consideraticonsideration in recruitment of manpower. Our organization charton in recruitment of manpower. Our organization chart explains the hierarchical levels of the

explains the hierarchical levels of the organizatioorganization.n. For strengthening the system,

For strengthening the system, following activities are carried out by following activities are carried out by Pharma consultants.Pharma consultants. 

 The in-house training programme covers all relevant aspects The in-house training programme covers all relevant aspects of cGMP.of cGMP. 

 Testing as per well defined specification control the input materials and releaseTesting as per well defined specification control the input materials and release

procedures for semi finished and finished products exit. Production as well as Quality procedures for semi finished and finished products exit. Production as well as Quality assurance monitors quali

assurance monitors quality by carrying out ty by carrying out in process testing during various stages of in process testing during various stages of manufacturing.

manufacturing. 

 Standard operating procedures are available for different operations. Products areStandard operating procedures are available for different operations. Products are manufactured as per procedure given in batch manufacturing records and recorded manufactured as per procedure given in batch manufacturing records and recorded accordingly.

accordingly. 

 Standard validation/calStandard validation/calibration protocols adhered for ibration protocols adhered for validation of all validation of all critical equipmentscritical equipments processes/in

processes/instruments/prostruments/products/system/utilducts/system/utilities ities etc.etc. 

 Master formula records, which are prepared for individual products, are adhered inMaster formula records, which are prepared for individual products, are adhered in batch manufacturing & testing processes.

batch manufacturing & testing processes. 

 MaintenancMaintenance history records e history records are maintained for critical instruments and are maintained for critical instruments and equipments toequipments to ensure proper preventive maintenance.

ensure proper preventive maintenance. 

 The assessment of effectiveness of QMS is The assessment of effectiveness of QMS is done by periodic self-inspection &done by periodic self-inspection & management review meeting.

management review meeting. a.

a. IncIncomoming ing matmaterierial Qual Qualialityty b.

b. PrPrododucuct t QuQualalitityy c.

c. CompComplianliance wce with sith systemystems / dos / documecument cont controlntrol d.

d. CusCustomtomer er cocomplmplaiaintsnts e.

e. CorrCorrectivective acte action tion to avoo avoid noid non-con-conformnformityity f.