Pre-Conference Session

23 October 2018

ICH Q7 How to do

– Hot Topics from the revised APIC guidance


This pre-Conference Session provides an interpretation of the GMP principles for the manufacture of APIs
based on APIC’s revised ICH Q7 How to do document. You will get to know

  • Which aspects of ICH Q7 have to be re-considered
  • What are the practical consequences of the ICH Q7 Q&A document
  • What has to be taken into account when preparing for a GMP inspection

Furthermore you will have the opportunity to reach clarification on ambiguous issues by bringing your
questions concerning ICH Q7 up for discussion.

This pre-conference session ideally complements the following 21st APIC/CEFIC European Conference on Active Pharmaceutical Ingredients.



Since its successful implementation in the regulatory framework by most authorities around the world
experience has been gained with the ICH Q7 Guideline on „Good Manufacturing Practice for Active Pharmaceutical
Ingredients“. Meanwhile it turned out that ambiguities related to the interpretation of some
sections in ICH Q7 may lead to misconceptions. Furthermore the principles outlined in the ICH Guidelines
Q8 – Q11, in particular the life cycle approach and some technical issues related to API manufacturing
procedures, need also to be considered in order to achieve a comprehensive implementation of GMP for

The ICH Q7 Questions & Answers Document which reached Step 4 of the ICH process in June 2015 intends
to remove these ambiguities and to contribute as well to harmonization of GMP inspections of
both small molecules and biotech APIs.

APIC has revised its ICH Q7 How to do document which intends to support industry with the implementation
of the ICH Q7 principles. The new ICH Q7 Q&A How to document which was developed
quite recently as a stand alone document to provide a detailed interpretation of the requirements of
the ICH Q7 Q&As is now integrated in the revised ICH Q7 How to do Guide.


Target Audience

This pre-conference session is designed for all persons involved in the manufacture of APIs especially for
persons from production, quality control, quality assurance and control, technical and regulatory affairs
departments. We are also addressing interested parties from the pharmaceutical industry and GMP inspectorates.


  • The revised ICH Q7 How to do Document – an overview

- Intention of the Htd Document
- Content
- Some highlights from the Htd Document
- Advantages to Industry of the Htd document

APIC „ICH Q7 How to do“ Document“
10.2 Distribution procedures
… For intercontinental API shipments a system should be in place to assure packaging and supply chain
integrity. If needed, special controls should be in place to assure shipments meet the defined requirements. ...
  • The ICH Q7 Q&A How to do Document; key aspects and highlights


APIC „ICH Q7 Q&A How to do“ Document
2 Quality Management
Does ICH Q7 expect that sampling be performed by the quality unit?
No. ICH Q7 does not prescribe specifically who should perform the sampling … However, the quality
unit has responsibility for reviewing and approving sampling plans … and procedures. …

Delegated sampling responsibilities should be proceduralised and evaluated by the QU for example during
an internal audit. [Interpretation by APIC]

  • Worked examples from therevised ICH How to do Document and the ICH Q7 Q & A Document
  • Workshop:
    Hot topics out of the revised ICH Q7 How to do Document and the ICH Q7 Q&A How to do


APIC „ICH Q7 How to do“ Document
15 Complaints and Recalls
…The API manufacturer should have a procedure describing the process and responsibilities re-lated to recalls/
product (API) traceability, and should be able to document that batches can be traced and reconciled.
Key personnel involved should be identified. Likewise, the responsibility for notifying customers and local
authorities, if applicable, should be addressed. …




Alejandro Sureda Salvadó, Farmhispania, Spain

Organic chemist with 18-years experience in the API manufacturing in different positions (Production, Analitycal Development Technician, Quality Control Manager and Quality Assurance Manager) in Farmhispania, S.A., Menadiona, Kern Pharma and Farmhispania Group. In his current position as Industrial Quality Manager and GMP Compliance Auditor he is responsible for Auditing of suppliers (Key Raw Materials, Registered Starting Materials, Intermediates, Contracted Services), GMP Training, Data Integrity upgrade, Validation and Qualification activities and supporting the Industrial Area (Production, Engineering, Maintenance, EHS) on CAPAs and Change Control.


Francois Vandeweyer, Janssen Pharmaceutica, Belgium

Graduated in 1979 as Bachelor in Chemistry. He joined Janssen Pharmaceutica (part of Johnson & Johnson) in 1981 in chemical development. Until 1995 increasing responsibilities within the Organisation mainly in the Quality Control Unit (Manager QC Lab 1994). Starting from 1995 he joined the QA department. Several Senior Manager responsibilities (sGMP Auditor – Release – Quality Systems). 2005 Sr Manager GMP Compliance Chemical Operations Belgium (sites Geel – Olen – Beerse). 2009 Director Global Compliance EMEA/AP for Johnson & Johnson.