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TOP 5 GMP Downloads

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

 

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

 

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

 

4. Risk Management
Apart from factual content you will find many tables, examples, forms, which can be used in daily practice.

 

5. Documenting Process Validation – A Drugmaker’s Guide
Document process validation in a way that’s sure to satisfy – and impress – regulators.

 

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News about GMP/cGMP

2014-01-21

Early this month, the China Food and Drug Administration (CFDA) issued an announcement on the implementation of the Good Manufacturing Practice for Drugs (2010 Revision) for sterile pharmaceutical products.

 
2014-01-14

As part of its transparency initiative the European Medicines Agency (EMA) has already published details of manufacturers who have violated GMP.

 
2014-01-14

According to pharmabiz, the government of India is planning a revision of its GMP guidelines – Schedule M – and considers making them on par with the WHO-GMP standards. Therefore, the Drugs Controller General of India (DCGI) has asked for inputs from experts to get their GMP standards on track with global standards.

 
2014-01-14

Late last month, the U.S. FDA and the EMA (European Medicines Agency) announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.

 
2013-12-11

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.

 
2013-12-11

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".

 
2013-11-29

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.

 
2013-11-25

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
 
 
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