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TOP 5 GMP Downloads

1. GDP Audit Checklist
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2. Quality Agreement
Standard draft to adapt and extend


3. Premises
Official requirements | material flow | room classes | and much more...


4. GMP Audit Checklist
for Pharmaceutical and API Manufacturers


5. Documenting Process Validation
A Drugmaker‘s Guide – step-by-step manual based on real-world examination experience


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News about GMP/cGMP


The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) published the results of their last meeting in Osaka: ICH Reviews Future ICH Topics and Its Organisation Towards Increased Engagement Globally. The ICH SC furthered discussions on governance and increased engagement of regulators.


In June the European Commission published the changes to Annex 16 of the EU GMP Guideline. One oft the first comments was submitted by the EFPIA (European Federation of Pharmaceutical Industries and Associations): Submission of comments to Annex 16 "Certification by a Qualified Person and Batch Release".


A new version of the Guidelines on Good Distribution Practice (GDP) of medicinal products was published by the European Commission.
The revised guidelines correct factual mistakes in subchapters 5.5. and 6.3., give more explanations on the rationale for the revision and provide a formal date of coming into operation. These guidelines, which replace the guidelines on GDP published in March 2013, are applicable as of 24 November 2013.


The European Commission has published the responses received regarding the planned revision of the following chapters of the GMP-Guidelines Part I - Basic requirements for Medicinal Products:

  • Chapter 3 Premises and Equipment
  • Chapter 5 Production
  • Chapter 6 Outsourced Activities
  • Chapter 8 Complaints and Product Recall

On 13 November 2013, Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) announced the next step of their joint efforts toward regulatory harmonization and the launch of a joint regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).


According to a press release on the PIC/S last meeting in Ottawa, Canada, a PIC/S Expert Circle on GDP has prepared a PIC/S GDP Guide which is currently under consultation within the organisation. The document will be a voluntary guidance and is based on the EU GDP Guide.


The European Commission has published a report that takes stock of the progress made in personalised medicine, and the opportunities and challenges it presents for healthcare systems.


The European Medicines Agency (EMA) and the US FDA have published a second joint Q&A document which provides guidance on the quality by design concept, a risk based approach to pharmaceutical development and manufacturing. It involves designing and developing pharmaceutical formulations and manufacturing processes to help ensure product quality; these concepts are described in the international guidelines ICH Q8, Q9, Q10 and Q11.

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