IPEC- Americas Ongoing Projects

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IPEC-­‐PDG  Working   group

Compendial  

Review/Harmonization

Hold  technical  meetings  with  PDG   on  as  needed  basis/meet  yearly   with  PDG

On-­‐going  monograph   harmonization

Meet  with  PDG  late  Oct  to  plan   agenda  for  Nov  meeting

JECFA/Food  Related   Issues  related  to  Mg   Stearate

Compendial  

Review/Harmonization

To  support  EFSA  (European  Food   Safety  Authority)  need  for  Mg   stearate  exposure  data,  where   used,  what  products  it's  used  in,   etc.,  work  with  IPEC  makers  &  users   of  Mg  stearate  to  gather  necessary   Mg  stearate  information.

1)  Dave  S.  to  create  and  send   summary  of  situation  to  IPEC   membership  

2)  DK  and  PZ  to  work  with  staff  to   develop  list  of  excipients  linked  to   each  IPEC  member

Support  Elemental   Impurity  Coalition

Compendial  

Review/Harmonization

Support  Trade  Association  coalition   on  the  Rationale  Implementation  of   Elemental  Impurities  

Rationale  implementation  of   Global  Elemental  Impurity   requirements  for  

pharmaceutical  excipients

Coalition  projects  include  -­‐     1)  develop  comments  re:USP   chapter  by  Mar  30  

2)  develop  Q&As  for  FDA  FAQ   3)  develop  real  data  on  acid  leach   methodology  

4)  finalize  PDE  Calculator  and   develop  instructions  

5)  summarize  and  share  (USP/ICH)   historical  acid  leach  information   USP  Monograph  

Modernization  Project

Compendial  

Review/Harmonization

Request  IPEC  member  companies   to  send  samples  of  the  13  

excipients  identified  in  the  FDA   letter  to  USP  along  with  any   methods  still  needed

Commitment  from  members   to  submit  samples

Report  from  members  on  Sept  26;   samples  of  guar  gum  sent  by   Ashland

Support  publication  of   FDA  2012  EI  study/data

Compendial  

Review/Harmonization

Work  with  John  Kauffman  and  Gang   Li  at  FDA  Research  labs  to  

substantiate  their  work  and  publish   an  article  in  Pharmaceutical  Science

Scientific  article  on   Elemental  Impurities  in   excipients  published  in  peer   reviewed  journal

Review  FDA  data/interpretation  of   data  and  finalize  draft  report

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Guidance  on  User   Comminication  with   Suppliers  (FOR  THE   PARKING  LOT)

Excipient  Qualification

A  guide/stimuli  article  or  addition   to  the  EIP  guide  which  would   discuss  the  communication   between  users  and  

suppliers/makers.    It  would  detail  /   describe  which  type  of  information   should  be  shared  between  the  two.

TBD

Some  notes  from  the  EQ  meeting   on  Feb.  26th:    It  has  been  proposed   to  have  better  guidance  on  what   users  should  communicate  to  their   suppliers  regarding  their  use  of  the   excipient.      It  was  agreed  that  users   should  share  more  “non-­‐

confidential”  information  on  how  a   material  is  used.    This  might  be  the   basis  for  a  new  guide  that  would   describe  what  type  of  information   should  be  shared.    This  might  be  a   perfect  fit  under  the  “excipient   qualification”  guide  or,  if  too  long   and  complex,  it  might  be  a   supplement/reference  in/to  the   guide.    

Excipient  Information  

Package Excipient  Qualification

Revise  2012  EIP  guide  and  develop   new  version.

Revised  EIP  Guide  published   as  Federation  Guide.

1)  Waiting  for  IPEC  Europe  (Helen   Stubbs)  to  communicate  with  us  to   have  first  joint  meeting

Quality  Agreement  

Guide Excipient  Qualification

Revise  2009  Quality  Agreement  and   develop  new  version

Revised  and  updated   version  of  Quality   Agreement  Guide  as   Federation  Guide.

1)  Waiting  for  IPEC  Europe  (Johanna   Eisele)  to  communicate  with  us  to   have  first  joint  meeting

Significant  Change  

Guide Excipient  Qualification

Revise  and  update  the  2009  version   of  IPEC  Significant  Change  Guide.    

To  publish  2014  IPEC   Significant  Change  Guide   (ideally  as  a  Federation   guide,  and  at  the  least  a  "bi-­‐ PEC  guide)

1)    Publication  of  the  final  guide  on   IPEC-­‐Americas  and  Europe  websites       2)  Paper  copies  if  needed  (EU  is   printing  some)  3)  Iain  to  give   presentation  at  IPEC  Europe  in  Feb.   in  Nice  France.    4)  ExcipientFest   Americas  in  Puerto  Rico  

presentation  to  take  place  on  April   28th

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How  to  Creat  a  Bi-­‐Pec  

Guide Excipient  Qualification

Develop  a  process  on  “best   practices/lessons  learned/policy”   on  how  to  create  a  “Bi-­‐PEC”  guide.     Included  will  be  a  discussion  around   how  to  communicate  that  a  

commenting  period  is  over.    

Protocol

Bretta/Heather  to  present  1st  draft   to  Executive  Committee  at  

December  meeting

IPEC  Global  Risk   Assessment  Strategy   (RAT  -­‐  Risk  Assessment   Team)

Excipient  Qualification

To  develop  a  risk  assessment  guide   which  would  include  1)  guidance  on   conducting    manufacturer’s  internal   risk  assessment  for  GMP  (EXCiPACT,   NSF/IPEC  363),    and  2)  risk  

assessment  from  users  perspective   (IPEC  Europe).    The  guide  may  also   cover  risk  assessment  for  atypical   actives,  decision  making  for   significant  changes  etc.        

IPEC  Americas  will  provide   to  IPEC  Federation-­‐  the   following  content  for  the   risk  assessment  guidance   document:    

•  Process  including  

methodologies  and  tool  box   for  conducting  risk  

assessment  

•  How-­‐to  chapters  on   internal  risk  assessment   from  excipient  

manufacturers  perspective •  How-­‐to  chapters  on   internal  risk  assessment   from  excipient  users   perspective

1)  A  draft  Table  of  Contents  for  the   Guide  has  been  developed  (Meera,   Lisa,  Bretta  Dale)  2)    Based  on   response  to  internal  poll,  experts   have  been  identified  to  lead   subteams  focussing  on  a  risk   assessment  methodology.      3)  The   charter  has  been  amended  and  sent   to  the  Federation

Excipient  Qualification  

Guide    (PARKING  LOT) Excipient  Qualification

Revise  and  update  the  latest   version  of  IPEC  Excipient   Qualification  Guide  

To  publish  an  IPEC  Excipient   Qualification  Guide  (ideally   as  a  Federation  guide,  and   at  the  least  a  "bi-­‐PEC  guide)

TBD

Bi-­‐PEC/IPEC  Glossary  of  

Terms Executive  Committee

review  and  update  current  2010   IPEC-­‐Americas  Glossary  and  work   with  other  PECs  to  make  it  global

IPEC  Federation  Glossary  of   Terms

get  feedback  from  IPEC-­‐Europe  on   draft  glossary  sent  to  them  in  2013 ANSI  cGMP  for  

Pharmaceutical   Excipient  Standard

Good  Manufacturing   Practice

Develop  ANSI  Pharmaceutical   Excipient  Standard

Approved  ANSI  

Pharmaceutical  Excipient   Standard

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FDASIA    Atypical  Actives   on-­‐going  activities

Good  Manufacturing   Practice

work  with  FDASIA  subcommittee  to   be  prepared  for  potential  meeting   with  FDA

Tool  chest  of  discussion   items  pertaining  to  atypical   actives  for  requested  FDA   meeting

1)  define  the  problems  and  propose   a  process  parallel  to  the  food  /   dietary  supplements  process  that   occurred  within  FDA  

2)  check  NDC  database  for  listings   for  common  atypical  actives   3)  inform  CHPA,  GPhA,  etc  about   IPEC  activities  and  suggest  coalition Revised  IPEC-­‐PQG  

Excipient  GMP  Guide

Good  Manufacturing   Practice

Rewrite  IPEC/PQG  GMP  Guide  with   updated  information  from  ANSI   Excipient  GMP  standard

Revised  IPEC-­‐PQG  Excipient  

GMP  Guide draft  revisions Validation  Guide Good  Manufacturing  

Practice

Develop  IPEC  GUIDE  on  Excipient   Validation,  including  Equipment,   Process,  Product,  Computer,   Cleaning  and  Analytical  Validation

Published  IPEC  GUIDE  on   Excipient  Validation

finalize  Validation  Guide  section  on   computerization

Technically  Unavoidable   Particles  Profile  (TUPP)   Guide  

Good  Manufacturing  

Practice Develop  IPEC  TUPP  GUIDE   Published  IPEC  TUPP  GUIDE

1)  submit  to  IPEC  office  for  final   editing  and  to  XC  for  final  approval   2)  review  with  FDA

Additives  found  in   excipients

Quality  by  Design   Product  Development

Develop  and  share  with  FDA  a  list  of   additives  commonly  found  in   excipients

Share  list  of  additives   commonly  found  in   excipients  with  FDA

Original  list  to  be  updated. Updated  project  proposal  to  be   drafted

Co-­‐processed  Excipient   Guide

Quality  by  Design   Product  Development

create  a  new  IPEC  Guide  pertaining   to  co-­‐processed  excipients

Published  IPEC  Co-­‐

processed  Excipient  Guide

Final  edits  to  be  made  and  then   sent  to  XC  for  approval

QbD  Excipients  and   Excipient  Variability   Guide

Quality  by  Design   Product  Development

Develop  IPEC  GUIDE  on  QbD   Excipients  and  Excipient  Variability

Published  Federation  IPEC   GUIDE  on  QbD  Excipients   and  Excipient  Variability

1)  Aim  to  have  version  to  send  to   other  PECs  after  Sept.  meeting QbD  Sample  Guide Quality  by  Design  

Product  Development

Create  and  publish  new  QbD   Sampling  Guideline

Published  IPEC  QbD  

Sampling  Guide draft  Guide Global  Ingredient  

Archival  System  (GinAS)   Project

Regulatory  Affairs

Help  communicate  and  support  the   FDA/NIH/global  regulatory  GInAS   innitiative

functional  Global  ingredient   identification  database  with   reviewed/reliable  ingredient   information

call-­‐in  to  bi-­‐weekly  GInAS  meetings,   attend  GInAS  public  workshop,   Washington  DC,  June  10-­‐11,  2014

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Addressing  US  Import  

issues Regulatory  Affairs

Address  current  issues  companies   are  currently  experiencing  when   importing  excipients  into  the  US.    

Response  from  FDA  on   Import  hold  letter.    IPEC-­‐ Americas  would  like  the   opportunity  to  connect  with   the  appropriate  resources  at   FDA  in  order  to  allow  both   parties  to  openly  

communicate  and   collaborate  on  this  topic.

None.    Milestone  achieved.    Bretta   Lichtenhan  and  Priscilla  Zawislak   attended  meeting  with  FDA  in   Rockville  in  June  of  2014.    Visit   report  was  created  after  the   meeting.    Meeting  was  able  to   resolve  current  issues.    In  addition,   FDA  was  formally  invited  to  come   speak  at  IPEC  in  September,  but   they  have  not  gotten  back  to  us.

FDA  IID  update Regulatory  Affairs Support  FDA  clean-­‐up  and  update   of  US  FDA  IID

Improved  FDA  IID  database   and  process  for  toxicology   assessments  for  families  of   similar  products

Meet  with  FDA  IID  Sub  team  to   1)  discuss  revisions  to  draft  FDA   toxicology  table  

2)  agree  on  interim  process  for   bridging  family  "safety"  information   3)  follow  up  on  Phase  1  IID  FAQ     4)  begin  review  of  Phase  II  IID  FAQ

Revise  IPEC  Master  File  

Guide Regulatory  Affairs

Update  content/instructions  and   format/granularity.    Target  working   with  FDA  to  define  their  current   and  future  needs  (e.g.  electronic   filing,  format/granularity,  etc)

Revised  IPEC  Master  File   Guide.      Work  on  draft  prior   to  september  meeting.     Target  date  is  end  of  2014.

Meeting  with  FDA  to  discuss  FDA   current  and  emerging  DMF   requirements

FDA  Portable  Document   Format  (PDF)  

Specifications

Regulatory  Affairs

We  need  to  clarify  with  the  FDA  on   what  PDF  attachments  to  

regulatory  filings  (NDAs,  INDs  or   ANDAs)  are    impacted  by  this   guidance.    Also,  IPEC  Americas  will   issue  a  position  paper  with  inpu   with  FDA.

IPEC  position  paper  

clarifying  FDA's  requirement   and  applicabiltiy  to  excipient   documents

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Acid  Leach/PQRI  

workshop;   Safety

Propose  a  project/program  to  PQRI   for  a  multi  day/multi  functional   (tox,  analytical,  USP,  FDA,  mfg.,  etc)   workshop  to  promote  an  EI  

workshop  focused  on  methods  and   the  analytical/toxicological  impact   of  acid  leach  vs.  total  digestion  

scheduled  multi  day/multi   functional  workshop

work  with  PQRI  to  finalize  workshop   plans  

XC  approval  and  agreement  to  fund   from  2014  budget

Steinberg  Award  for  

Foundation Safety

develop  a  branding/marketing  plan   for  the  award

sustainable  plan  for   delivering  the  Marshall   Steinberg  Award

identify  new  definition  and  criteria   for  the  award  to  recognize  not  only   toxicologist  but  all  involved  in  the   evaluation,  qualification,  

assessment  and  promotion  of  novel   and  existing  excipients  for  safety Chris  DeMerlis/Elaine  Knight  agreed   to  rediscuss  the  award  at  SOT  with   Shawn  at  the  upcoming  SOT   meeting.

Form  a  Novel  Excipient  

sub-­‐committee  projects Safety

Define  members  to  work  in  an  IPEC-­‐ Americas  Novel  Excipient  

subcommittee,  formalize  team  and   develop  mission  

Sub-­‐committee  and  projects   identified,  mission  /  charter   developed

meet  with  team  identified  in  Q1  to   develop  a  mission  statement  and  to   determine  how  to  move  forward

IQ  Initiative;   Safety

IPEC-­‐Americas/IQ  Consortium   subteam  to  prepare  for  a  meeting   with  the  FDA  to  discuss  a  new   pathway  for  novel  excipients  in   June  2014

open  ended,  TBD

Prepare  a  backgrounder  document   to  send  to  the  FDA  providing  history   and  legislative  reasons  why  a  new,   novel  excipient  pathway  is  critical Small  subteam  (Nigel  Langley/Chris   DeMerlis  from  IPEC  and  Keith   Horpol/?  Will  participate  in  a  round   table  inteview  by  PharmTech  during   ExcipientFest  on  the  subject  of   Novel  Excipients.

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Stimuli  article  on  novel   excipient  solutions  for   drug  delivery

Safety

Develop  and  publish  stimuli  article   on  benefits  of  using  NOVEL   EXCIPIENTS  in  drug  applications

Stimuli  Article  on  Novel   Excipients

Develop/publish  IPEC-­‐Americas   “concept  paper”  (stimuli  article?)   on  solutions  for  how  novel  

excipients  might  be  used  to  resolve   current  drug  delivery  issues.     Nano  technology/nano-­‐

materials  subteam Safety

define  a  working  group/chair   person  to  monitor  for  

regulatory/toxicology  issues  related   to  nano  materials.    It  was  

recommended  that  the  team  might   focus  on  such  things  as  analytical  

Sub-­‐team  identified  and    a   mission  statement  

developed

1)  survey  IPEC-­‐Americas  members   for  those  interested  to  participate   in  nano-­‐technology  team;  2)  work   with  the  sub-­‐team  members  to   develop  a  mission  statement.   *  for  questions  on  any  

committee  or   committee  activity,   please  contact  IPEC-­‐ Americas  office

Figure

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