ICH Q7 How to do - Document - Hot Topics from the revised APIC guidance

Tuesday | 25 October

Objectives

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. During interactive sessions you will get to know

  • Which aspects of ICH Q7 have to be re-considered
  • What are the practical consequences of the ICH Q7 How to do 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 25th APIC/CEFIC Global GMP & Regulatory API Conference.

Background

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 APIs.

Annually, APIC has revised its ICH Q7 How to do document, which intends to support industry with the implementation of the ICH Q7 principles. More than 12 chapters has been adjusted and updated in the last 4 years and provide answers to the questions raised by the API
industry.

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, 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 How to do Document
  • Content
  • Some highlights from the How to do Document
  • Advantages to Industry of the How to do Document


APIC’s ICH Q7 How to do Document 10.2 Distribution procedures
… For 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 How to do Document – key aspects and highlights

  • Understand specific changes in chapters like:
    – Material management
    – Brokers, traders and distributers
    – Production and in process controls
    – Storage and distribution
    – Contract Manufacturers and contract labs
  • Benefit from APIC’s Task Force members’ experiences
  • Good opportunity to discuss unclarities


APIC’s ICH Q7 How to do Document
Chapter 17: Agents, Brokers, Traders, Distributors, Repackers and Relabellers
…Current expectation are that if the API or intermediate is re-packed or re-labelled the trader etc. should perform a documented risk assessment and determine which sections of Q7 are applicable to their activities. Section 13, Change Control and an appropriate Quality system are always applicable to all operators and their operations…


Real life cases and how to use the ICH Q7 How to do Document in implementing GMP compliant systems – Part I and II

  • General insight on the use of the How to Do Document in implementing GMP requirements
  • Examples of industry combined with best practices in last updated chapters
  • Explain benefits of the use of the How to Do Document in real life cases


Take advantage of the experiences of our speakers and send us your questions and real life scenarios/challenges related to the ICH Q7 requirements prior to the pre-conference session. Your questions and examples are welcome and will be answered as comprehensively as possible by the experts during the Q&A sessions and exchange sessions.


The next revision of the ICH Q7 How to do Document – how to support

  • Exchange “How to Do” hurdles and “learn” from attendees and APIC representatives
  • Contribute in updating the next “How to Do” edition
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