This presentation is compiled by “ Drug Regulations” a
non profit organization which provides free online
resource to the ...
 This presentation is compiled by “ Drug
Regulations” from freely available resources
like the FDA on the World wide web....
 Pilot program of the EMA and FDA
 Launched in March 2011
 Aimed at a parallel assessment of certain
quality/CMC sectio...
 The objective of the pilot is to ensure
◦ Consistent implementation between EU and US of
ICH Q8, 9, 10, 11 guidelines in...
 Voluntary pilot program open to
◦ New Marketing Authorisation Applications (MAAs)
◦ New Drug Applications (NDAs),
◦ Type...
 Voluntary pilot program
◦ Submitted to either both agencies at the same time
resulting in a parallel evaluation, or
◦ Ei...
 The first EMA-FDA parallel assessment of
QbD elements of an initial marketing
authorisation application finalised.
 Con...
 The EMA and FDA reached agreements on a
wide range of QbD aspects
 Summary of agreements reflected in the Q&A
follow.
...
 Provide prospective description of the quality
characteristics a drug product should achieve
to ensure the desired quali...
 Specify QTPP only for the finished product.
 Preferably submit the QTPP information in a
tabular format in the applicat...
 Provide a list of CQAs for drug substance,
finished product, and excipients when
relevant.
 Provide acceptance limits f...
 Include a discussion of how the drug
substance and excipient CQAs relate to the
finished product CQAs based on
◦ Prior k...
 Devise the control strategy to ensure that the
drug substance and finished product CQAs
are consistently within the spec...
 ICH Q8(R2)
 A critical process parameter has an impact on
a critical quality attribute.
 A critical process parameter ...
 Pilot programme submission included a
three-tier classification for quality attributes
and process parameters:
◦ Critica...
 A critical factor was defined as a factor that
led to failure during experimentation.
 A factor that had not led to fai...
 Different applicants will use the term “key”
differently.
 The Agencies do not support the use of the
term Key Process ...
 This terminology may be used in the
pharmaceutical development section.
 However, classify all parameters that have an
...
 Provide same level of detail in the
manufacturing process description
irrespective of the development approach.
 For US...
 For US FDA,
◦ However, proposed or actual commercial scale
Master Production Records are required for generic
and 505(b)...
 Provide comprehensive process descriptions
 Describe process steps in a sequential
manner
 Provide details of batch si...
 Identify the critical steps and points at which
process controls, intermediate tests or final
product controls are condu...
 Do not restrict the process parameters in the
manufacturing process description to the
critical ones.
8/22/2013 23
Drug ...
 Describe all parameters that have been
demonstrated during development as
needing to be controlled or monitored during
t...
 Industry has applied QbD concepts in the
area of analytical methods based on
◦ Risk assessments
◦ Statistically designed...
 The ATP parallels Quality Target Product
Profile (QTPP)
 MODR parallels the Design Space
 No international consensus o...
 Analytical process profile acceptable as a
qualifier of the expected method
performance.
 Analytical methods that have ...
 Do not switch between these two types of
methods without appropriate regulatory
submission and approval.
8/22/2013 28
Dr...
 Apply principles similar to “Design Space” for
MODRs.
 Data to support an MODR
◦ Appropriately chosen experimental prot...
 More lessons learnt & Agency Expectations will
be published.
◦ Design Space verification
◦ Design Space
◦ Risk assessmen...
 This presentation is compiled by “ Drug
Regulations” from freely available resources
like the FDA on the World wide web....
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Qb d agency expectations

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In March 2011, the EMA and FDA launched a pilot program that aims at a parallel assessment by both agencies of certain quality/CMC sections which are relevant to Quality by Design (QbD). This voluntary pilot program is open. This presentation gives a summary of the FDA and EMA expectation for QbD submissions based on the pilot programme.

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Qb d agency expectations

  1. 1. This presentation is compiled by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 8/22/2013 1
  2. 2.  This presentation is compiled by “ Drug Regulations” from freely available resources like the FDA on the World wide web.  “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.  Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 8/22/2013 2 Drug Regulations : Online Resource for Latest Information
  3. 3.  Pilot program of the EMA and FDA  Launched in March 2011  Aimed at a parallel assessment of certain quality/CMC sections relevant to QbD : ◦ Development, ◦ Design space and ◦ Real time release testing. 8/22/2013 3 Drug Regulations : Online Resource for Latest Information
  4. 4.  The objective of the pilot is to ensure ◦ Consistent implementation between EU and US of ICH Q8, 9, 10, 11 guidelines in the assessment process and ◦ To facilitate sharing of regulatory decisions on new regulatory concepts. 8/22/2013 4 Drug Regulations : Online Resource for Latest Information
  5. 5.  Voluntary pilot program open to ◦ New Marketing Authorisation Applications (MAAs) ◦ New Drug Applications (NDAs), ◦ Type II Variations/Prior-approval supplements (sNDA) ◦ Scientific Advice requests/CMC formal meeting requests that include QbD/Process Analytic Technology (PAT) elements 8/22/2013 5 Drug Regulations : Online Resource for Latest Information
  6. 6.  Voluntary pilot program ◦ Submitted to either both agencies at the same time resulting in a parallel evaluation, or ◦ Either to EMA or FDA in which case the agency doing the evaluation obtains consultative advice from the other agency. 8/22/2013 6 Drug Regulations : Online Resource for Latest Information
  7. 7.  The first EMA-FDA parallel assessment of QbD elements of an initial marketing authorisation application finalised.  Consultative advice procedures finalized 8/22/2013 7 Drug Regulations : Online Resource for Latest Information
  8. 8.  The EMA and FDA reached agreements on a wide range of QbD aspects  Summary of agreements reflected in the Q&A follow.  In the future, more lessons learnt resulting from this EMA-FDA pilot program will be published. 8/22/2013 8 Drug Regulations : Online Resource for Latest Information
  9. 9.  Provide prospective description of the quality characteristics a drug product should achieve to ensure the desired quality, taking into account ◦ Safety and ◦ Efficacy of the drug product. 8/22/2013 9 Drug Regulations : Online Resource for Latest Information
  10. 10.  Specify QTPP only for the finished product.  Preferably submit the QTPP information in a tabular format in the application. 8/22/2013 10 Drug Regulations : Online Resource for Latest Information
  11. 11.  Provide a list of CQAs for drug substance, finished product, and excipients when relevant.  Provide acceptance limits for each CQA  Provide a rationale for designating these properties as a CQA. 8/22/2013 11 Drug Regulations : Online Resource for Latest Information
  12. 12.  Include a discussion of how the drug substance and excipient CQAs relate to the finished product CQAs based on ◦ Prior knowledge ◦ Risk assessment or ◦ Experimental data 8/22/2013 12 Drug Regulations : Online Resource for Latest Information
  13. 13.  Devise the control strategy to ensure that the drug substance and finished product CQAs are consistently within the specified limits.  Preferably provide information on CQAs in a tabular format in the application 8/22/2013 13 Drug Regulations : Online Resource for Latest Information
  14. 14.  ICH Q8(R2)  A critical process parameter has an impact on a critical quality attribute.  A critical process parameter should be monitored or controlled to ensure the process produces the desired quality. 8/22/2013 14 Drug Regulations : Online Resource for Latest Information
  15. 15.  Pilot programme submission included a three-tier classification for quality attributes and process parameters: ◦ Critical, ◦ Key and ◦ Non-critical. 8/22/2013 15 Drug Regulations : Online Resource for Latest Information
  16. 16.  A critical factor was defined as a factor that led to failure during experimentation.  A factor that had not led to failure within the range studied, but still may have an impact on product quality, was considered as a key factor. 8/22/2013 16 Drug Regulations : Online Resource for Latest Information
  17. 17.  Different applicants will use the term “key” differently.  The Agencies do not support the use of the term Key Process Parameters (KPP)  KPP is not an ICH terminology.  Agencies recommend not to underestimate assignment of criticality specially when a robust proactive control strategy mitigates a risk of failure. 8/22/2013 17 Drug Regulations : Online Resource for Latest Information
  18. 18.  This terminology may be used in the pharmaceutical development section.  However, classify all parameters that have an impact on a CQA as critical in the ◦ 3.2.P.3.3 “Description of the Manufacturing Process and Process Controls” , ◦ 3.2.P.3.4 “Control of Critical Steps and ◦ Intermediates” sections 8/22/2013 18 Drug Regulations : Online Resource for Latest Information
  19. 19.  Provide same level of detail in the manufacturing process description irrespective of the development approach.  For US FDA, ◦ A detailed process description can be submitted in lieu of a Master Production Record for drug product manufacturing for 505(b)(1) products. 8/22/2013 19 Drug Regulations : Online Resource for Latest Information
  20. 20.  For US FDA, ◦ However, proposed or actual commercial scale Master Production Records are required for generic and 505(b)(2) products.  For EU, ◦ There is requirement for a full description of the manufacturing process in all cases. 8/22/2013 20 Drug Regulations : Online Resource for Latest Information
  21. 21.  Provide comprehensive process descriptions  Describe process steps in a sequential manner  Provide details of batch size(s) and equipment type. 8/22/2013 21 Drug Regulations : Online Resource for Latest Information
  22. 22.  Identify the critical steps and points at which process controls, intermediate tests or final product controls are conducted.  Provide necessary detail in terms of appropriate process parameters along with their target values or ranges. 8/22/2013 22 Drug Regulations : Online Resource for Latest Information
  23. 23.  Do not restrict the process parameters in the manufacturing process description to the critical ones. 8/22/2013 23 Drug Regulations : Online Resource for Latest Information
  24. 24.  Describe all parameters that have been demonstrated during development as needing to be controlled or monitored during the process to ensure that the product is of the intended quality. 8/22/2013 24 Drug Regulations : Online Resource for Latest Information
  25. 25.  Industry has applied QbD concepts in the area of analytical methods based on ◦ Risk assessments ◦ Statistically designed experiments ◦ Analytical Target Profiles (ATP) ◦ Method Operational Design Ranges (MODR) 8/22/2013 25 Drug Regulations : Online Resource for Latest Information
  26. 26.  The ATP parallels Quality Target Product Profile (QTPP)  MODR parallels the Design Space  No international consensus on the definition of ATP and MODR.  Agencies will evaluate applications on a case- by-case basis 8/22/2013 26 Drug Regulations : Online Resource for Latest Information
  27. 27.  Analytical process profile acceptable as a qualifier of the expected method performance.  Analytical methods that have different principles (e.g., HPLC to NIR) will not be considered equivalent solely on the basis of conformance with the ATP. 8/22/2013 27 Drug Regulations : Online Resource for Latest Information
  28. 28.  Do not switch between these two types of methods without appropriate regulatory submission and approval. 8/22/2013 28 Drug Regulations : Online Resource for Latest Information
  29. 29.  Apply principles similar to “Design Space” for MODRs.  Data to support an MODR ◦ Appropriately chosen experimental protocols to support the proposed operating ranges/ conditions; and ◦ Demonstration of statistical confidence throughout the MODR. 8/22/2013 29 Drug Regulations : Online Resource for Latest Information
  30. 30.  More lessons learnt & Agency Expectations will be published. ◦ Design Space verification ◦ Design Space ◦ Risk assessment level of detail in submissions, ◦ Continuous process verification and ◦ Continuous manufacturing. ◦ Assessment of validation requirements as identified in ICH Q2(R1) throughout the MODR ◦ Confirmation of system suitability across all areas of the MODR. 8/22/2013 30 Drug Regulations : Online Resource for Latest Information
  31. 31.  This presentation is compiled by “ Drug Regulations” from freely available resources like the FDA on the World wide web.  “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.  Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 8/22/2013 31 Drug Regulations : Online Resource for Latest Information

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