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GMP Inspections in Europe: Proven Strategies on How to Prepare

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TOP 5 GMP Downloads

1. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.


2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.


3. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.


4. Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to preparing a company for compliance with Good Distribution Practice (GDP).


5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance


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News about GMP/cGMP

Annex 13 EU GMP Guideline published

On February 3, 2010 the European Commission published the revised Annex 6 "Investigational Medicinal Products" of the EU GMP Guideline. Deadline for comming into operation is until July 31, 2010.


Changes/ News:

  • Revision to reinforce the principle of independence between production and quality control functions in cases where the number
  • of personnel involved is small.
  • Changes to sections 36 and 37 to supplement, for investigational medicinal products, the guidance for reference and retention samples
  • given in Annex 19.
  • An additional note has been introduced to clarify the meaning of “reconstitution” as referred to in article 9.2 of Directive 2005/28/EC.
  • The content of the Batch Certificate referred to in Art. 13(3) of Directive 2001/20/EC, agreed following a separate public
  • consultation, has been added as an attachment.

EC/ Annex 13

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