About the ICH Q7 Question and Answer Document (ICH Q7 Q&A)

About the ICH Q7 Q&A

About the ICH Q7

Question and Answer
Document
(ICH Q7 Q&A)
Rosimeire Pereira Alves da Cruz, ANVISA
Stephan Rnninger, Amgen

PDA - PIC/S ICH Q7 Training

PIC/S and Parenteral Drug Association (PDA), January 2015
Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged.

About the ICH Q7 Q&A

Why now?
ICH Q7: A global applied guideline
- A what to do document
- Addresses all current needs incl.
Distribution of APIs (GDP)
Agent, Traders, Distributors responsibility

The ICH Q7 Q&A is for clarification of uncertainties

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About the ICH Q7 Question and Answer Document (ICH Q7 Q&A)

About the ICH Q7 Q&A

Working
Process
to the
Q&A
at ICH

Goal: One harmonised Q&A

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About the ICH Q7 Q&A

Principles of the ICH Q7 Q&A

The ICH Q7 Q&A is NOT
-

Explaining How to do
Restating the text from ICH Q7
Enlarging scope of ICH Q7
Addressing too specific questions
Establishing new requirement
Addressing regional matters
Outdated, no longer relevant
Including topics which are better handled in a training
A What to do document
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About the ICH Q7 Question and Answer Document (ICH Q7 Q&A)

About the ICH Q7 Q&A

References
The documents are published at www.ich.org

ICH E2E
ICH Q1A
ICH Q5A

ICH Q5B

ICH Q5D

ICH Q6B

ICH Q7
ICH Q8(R2)

ICH Q9
ICH Q10
ICH Q-IWG
ICH Q11

Pharmacovigilance Planning, Nov. 2004.

Stability testing of new drug substance and products, Feb. 2003.
Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology
Products Derived from Cell Lines of Human or Animal Origin, Sept. 1999.
Quality of biotechnological products: Analysis of the construct in cells used for the
production of r-DNA derived protein products, Nov. 2005
Quality of Biotechnological Products: Derivation and Characterization of Cell
Substrates Used for Production of Biotechnological/Biological Products, July 1997.
Specifications: Test Procedures and Acceptance Criteria for
Biotechnological/Biological Products, Mar. 1999.
Good Manufacturing Practice of APIs, Nov. 2000.
Pharmaceutical Development, Aug. 2009; Part I: Pharmaceutical Development, Nov.
2006; Part II: Annex to Pharmaceutical Development, Nov. 2008.
Quality Risk Management, Nov. 2005; and the ICH Q9 Briefing pack.
Pharmaceutical Quality Systems, Jun. 2008.
Training Programme for ICH Q8/Q9/Q10, Nov. 2010.
Development and Manufacturing of APIs, May 2012.

ICH Q7 is not a stand alone document

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About the ICH Q7 Q&A

Preface

Q&As are linked and cross-referenced to the respective chapters of Q7

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About the ICH Q7 Question and Answer Document (ICH Q7 Q&A)

About the ICH Q7 Q&A

ICH Q7 Q&A Clarification of Uncertainties

ICH Concept paper: Issues to be resolved
Output from the review of existing Q&As
(e.g., PIC/S, initial regulatory / PDA training 2002)
- The PIC/S Q&A document including 27&4 Q&As
considered and consolidated by the IWG. These Q&As
included among others the Q&As gathered during the
initial Regulatory/PDA training 2002

About the ICH Q7 Q&A

ICH Q7 Q&A Clarification of Uncertainties

ICH Concept paper: Issues to be resolved
Technical issues for clarification such as
1.
2.
3.
4.
5.

Application in the supply chain control

Contractor/supplier management (outsourcing)
Monitoring of impurity profiles
Quality systems
Applicability to biologicals/biotech and relationship
with Q5D
6. GMP expectations in the development phase
(manufacturing for clinical trials)
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About the ICH Q7 Question and Answer Document (ICH Q7 Q&A)

About the ICH Q7 Q&A

ICH Q7 Q&A Clarification of Uncertainties

ICH Concept paper: Issues to be resolved
The Q&A addresses the technical issues for
clarification
- All six technical issues are each addressed in one or
more Q&As in sections 17, 16, 11, 2, 18 and 19 of Q7.
- Furthermore all other sections are also addressed by
one or several Q&As (except one: section 9 on
Packaging and identification labelling of APIs and
intermediates)
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About the ICH Q7 Q&A

ICH Q7 Q&A Clarification of Uncertainties

ICH Concept paper: Issues to be resolved
Impact of the implementation of ICH Q8/Q11,
Q9, and Q10 on Q7, see also Quality IWG
Q&As and Points to Consider
The Q&A includes
- Different Q&As refer to one or more of the ICH
guidelines Q8/Q11, Q9 and Q10
- These guidelines have been considered when drafting
answers, where applicable
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About the ICH Q7 Question and Answer Document (ICH Q7 Q&A)

About the ICH Q7 Q&A

San Diego
Nov 2012
Brussels
June 2013

Osaka
Nov 2013
Minneapolis
June 2014
Lisbon
Nov 2014

Acknowledgement: ICH Q7-IWG

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About the ICH Q7 Q&A

Key Message
The ICH Q7 document is intended to be
read in its entirety regardless of the
nature of the manufacturing activities
being conducted to fully understand the
linkages between certain sections and
successfully implement appropriate
GMPs at all stages of the API supply
chain, including distribution.

ICH Q7
2001

ICH Q7-IWG Q&A

Read and implement existing guidelines

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