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Updates Forecast & History


GMP Compliance Adviser Update No. 9/2018

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP in Practice

Chapter 2
2.C Training Management (NEW)

The sequence of chapters 2.A to 2.E has been changed for editorial reasons.
Chapter 10 10.E Microbiological monitoring (NEW)

This chapter represents an up-to-date combination of the former chapters 11.E Environmental monitoring and 12.J Microbiological monitoring.

The new chapter 10.E Microbiological Monitoring combines all aspects related to sterile as well as non sterile preparations.

Chapter 11

The content of chapter 11 Production has been separated:

The former chapters 11.A to 11.E now constitute the new chapter 10 Hygiene (see above).

The former chapters 11.F to 11.L can now be found in chapters 11.A to 11.G.

GMP Regulations

Chapter C
EU Directives and Guidelines
C.5 EU GMP Guide Part II: Basic Requirements for Active Substances used as Starting Materials combined with GMP for APIs: “How to do“ Document by APIC/CEFIC Interpretation of the ICHQ7 Guide

Chapter E

E.3.C ICH Q3C(R7): Impurities: Guideline for Residual Solvents


GMP in Practice

Chapter 2 Personnel

2.C Training management

A company’s obligation to utilise only adequately trained personnel and to be able to document their training status is a central requirement of the governing regulations. A uniform and centrally managed training management system greatly simplifies compliance with these requirements.

Paper-based systems, even those which use supporting electronic systems such as MS Word or Excel provide adequate support for the efficient management of training only in limited cases. It is much more advantageous to use an electronic system for employee qualification which is closely linked with the document management system or even integrated directly with it. Above and beyond this, the system should manage and schedule training courses and qualifications which are not related to specific documents.

It is possible to manage the requirements placed on various job positions in a company flexibly via training profiles. Every employee is assigned his or her own employee skill matrix to which different training profiles can be linked. The distribution of document training assignments can be performed using the training profiles and furthermore, they can be used to map the specific additional qualification requirements.

With the support of an electronic training management system the planning of training courses as well as the control of target/actual training status for individual employees can be greatly simplified. An electronic system is very useful for presentation of the training system during an inspection as well as for a rapid check of target/actual status without the strenuous manual analysis of data tables (MS Excel or Word). (Thilo Gukelberger, Silke Schwiertz)

Chapter 10 Hygiene

10.E Microbiological Monitoring

When sterile preparations are manufactured and filled, all potential microbial causes of contamination from the ambient environment must be under control. Air, surfaces and personnel are the main sources of contamination. A monitoring program must be in place that regulates levels, sampling points, frequencies, methods, equipment, etc. and actions to be taken when deviations occur. Great emphasis should be placed on the selection and testing of culture media. This also applies to the manufacture and filling of non-sterile preparations, whereby levels and frequency of monitoring are determined for each individual facility.

Growth controls are a useful tool for evaluating culture media without evidence of growth that were used during hygiene monitoring. They rule out the likelihood of incorrect negative results. Growth controls check the functionality of the culture medium used and the disinfectant neutraliser it contains. The FDA and US pharmaceutical industry are increasingly focusing on the use of in-house isolates during method suitability testing. The authors also describe how a hygiene library is set up and how it can be used. When sterile preparations are manufactured and filled, all potential microbial causes of contamination from the ambient environment must be under control. (Frank Kugler, Melanie Braun, Hanfried Seyfarth, PhD)

GMP Regulations

Chapter C EU Directives and Guidelines

C.5 EU GMP Guide Part II: Basic Requirements for Active Substances used as Starting Materials combined with GMP for APIs: “How to do“-Document by APIC/CEFIC Interpretation of the ICH Q7 Guide

The APIC/CEFIC has further updated the “How to do”-document in the light of recent regulatory requirements. In the new Version 11 of November 2018, the following chapters have been revised:

  • Chapter 2 Quality Management
  • Chapter 9 Packaging and Identification Labelling of APIs and Intermediates
  • Chapter 14 Rejection and Reuse of Materials.
In providing examples of commonly applied solutions and practical assistance on how requirements and recommendations can be met and/or interpreted the “How to do” guide describes current practice. It aims at helping pharmaceutical manufacturers with the implementation of the GMP Guide for APIs.

Chapter E ICH-Guidelines

ICH Q3C(R7): Impurities: Guideline for Residual Solvents

The R7-version of ICH Q3C was published on 25 October 2018. This new version is a result of an error correction of the PDE for ethylenglycol as per the correct value calculated in Pharmeuropa, Vol. 9, No. 1, Supplement, April 1997 S36.

Ethylenglycol is now listed with a new PDE of 3.1 mg/day and a concentration limit of 310 ppm (before: 6.2 mg/day and 620 ppm).

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