GMP Schedule M.pptx

GMP

Definition

Definition

 _{That part of QA which ensures that products}

are consistently produced and controlled to the quality standards as per the

The Early Beginnings

 _{Home remedies, ointments and “miracle}

elixirs”

Public Involvement



₁₉₀₅

Upton Sinclair

 _{Exposure of unsanitary}

Meat packing plants.

 _{Increased Public awareness}

And involvement

 _{Pure Food and Drug Act}

A Time line of GMP

 _{1902 - Development of the Biologic Control Act}

 _{1906 - Development of the Pure Food and Drug Act}  _{1938 - Federal Food, Drug and Cosmetic Act}

 _{1941 - Initiation of GMP}

 _{1944 - Development of Public Health Services Act}  _{1962 - Kefauver-Harris Drug Amendments released}  _{1963 - Establishment of GMPs for Drugs}

 _{1975 - CGMPs for Blood and Components Final Rule}  _{1976 - Medical Device Amendments}

 _{1978 - cGMPs for Drugs and Medical Devices}  _{1979 - GLPs Final Rule}

1941 Initiation of GMP

 _{Sulfathiaziole tablets contaminated with phenobarbital}  _{1941 - 300 people died/injured}

 _{FDA to enforce and revise manufacturing and quality control}

requirements

 _{1941 - GMP is born}  _{Thalidomide tragedy}

 _{Thousands of children born with birth defects due to adverse}

drug reactions of morning sickness pill taken by mothers

 _{Strengthen FDA’s regulations regarding experimentation on}

humans and proposed new way how drugs are approved and regulated

Areas to be Covered

 _{General considerations}  _Personnel

 _Premises  _Equipment  _Sanitation  _SOP’s

 _{Raw Materials}

 _{Self Inspection And Audit}  _{Master Formula Records}

Areas to be Covered(cont..)

 _{Warehousing Area}  _{Reference Samples}

General considerations

 _{Compliance with GMP}

 _{Consistent uniform batches}  _{Location And surroundings}  _{Water system}

PERSONNEL

 _{Qualified Personnel}

a)Experienced

b)Sufficient Number

Premises

Points to be Consider

 _Location  _Design

Premises

Location

 _{Geography, climate,and economic factors}  _Neighbours

a) What do they do?

Premises must be located to minimize risks of cross-contamination,

e.g. not located next to a malting factory with high airborne levels of yeast

Premises

Premises

Design  _{Minimize risks of errors}

 _{Permit effective cleaning}

 _{Permit effective maintenance}

 _{Avoid cross-contamination, build-up of dirt and} dust

 _{Maximum protection against entry of insects, birds} and animals

Premises

Design(cont..)

 _{Maximum protection against entry of insects, birds and animals}  _{Specific Areas}

1) Production areas

2) Quality control areas 3) Weighing areas

4) Storage areas 5) Ancillary areas

Premises

 _Hygiene

 _{Eating,Drinking,Smoking Should not be}

Premises

Construction

 _{Measures should be taken to prevent}

cross-contamination

 _{Dust control measures (including extraction of}

dust and air)

 _{No areas for dust accumulation}  _{Easily cleanable surfaces}

 _{Proper air supply}

Premises

 _{Finishing floors,walls,and Ceilings}

 _{Should be smooth, impervious, hard-wearing,}

Equipments

located,designed,construcetd,adapted and

maintained to suit the operation to be carried out.  _{Should be made of non reactive material,such as}

High grade of steel(316,302)  _{Equipment should}

a) Caliberated b)Checked

Sanitation

 _{Written procedures}

• _{hygiene, health and clothing practices} • _{waste disposal}

Sanitation

 _{Practices not permitted}

a)eating, smoking

Standard Operating Procedure

 _{There shall be written Standard Operating}

Procedure for each operation

 _It

a)For Eqipments b)For sampling c)For Testing d)For Process

Raw Materials

 _{An Inventory should be maintained for Raw}

materials to be used at any stage of manufacture

Self Inspection And Audit

 _{Regular independent inspection is necessary}

to evaluate the manufacturer’s compliance with GMP in all aspects of manufacturing

 _{Procedure for self inspection shall be}

documented indicating

 _a)Evaluation  _b)Conclusion

Master Formula Records

 _{There shall be MFR relating to all manufacturing procedures}

for each product and batch size to be manufacture

 _{It should}

i)The name of the product

ii)Quantity,of all starting materials to be used

iii)A statement of the expected final yield with acceptable limits.

iv) Principal equipment to be used

v) Detaild stepwise processing instructions and the time taken for each step

vi)Any special precations

Batch Manufacturing Records

 _{There shall be Batch processing record for each}

product.

 _{During Manufacturing or Processing the following}

information shall be recorded

 _It

include-_{The name of the product}

_{The number of Batch being manufactured}

_{Dates and time of commencement of batch and}

completion

_{Initials of operator}

Warehousing Area

 _{Warehousing area should be designed and}

adapted to ensure good storage conditions.

 _{Should be Clean,dry and maintained with}

acceptable temperature limits.

 _{Should have appropriate house-keeping and}

rodents,pests and vermin control.

 _{Seprate sampling area for active raw material}

and excipients.

Reference Samples

 _{Should be taken in sufficient quantity from}

each lot of active ingridient to carry out all the tests

 _{These samples should be retained for a period}

of 3 months after the date of expiry of the last batch produced from that active ingridient

 _{Samples of raw material should be stored in}

Reference Samples

 _{Samples of finished formulations shall be}

Validation and process validation

 _{Essential part of GMP}

 _{Necessary to achieve the intended results}

 _{A written record is prepared summarizing recorded result and} conclusions shall be prepared ,documented and maintained  _{Should be necessary}

when- _{a)Any new new master formula or method of} prepration is adopted

b)For critical process

c)any changes in the equipment,or when using a new equipment,it is first validated to demonstrate its consistentency of

Labels And Other Printed Materials

 _{All containers and equipment should bear}

labels

 _{Different colour coded labels should be used}

Labels And Other Printed Materials(cont..)

 _{The Printing should be done in bright colours}  _{The label should contain all the prescribed}

Quality Assurance

 _{The main objective of the quality assurance is to} ensure the products are of the quality required for their intended use



Functions- _{i)Adequates are made for manufacuring,supply and} the use of correct starting and packing material

 _{ii)Adequate control on starting}

material,intermediate,and bulk products.

References

 _{Blackwell, John. 1906: Rumble Over ‘The Jungle’. 31 Aug.}

2008. http://www.capitalcentury.com/1906.html

 _{FDA Food and Drug Administration. GMP Combination}

Handbooks. 31 Aug. 2008. http://images.google.com