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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


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.


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


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.


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.


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.


The US Food and Drug Administration (FDA) has proposed a new regulation that would require pharmaceutical manufacturers to provide the agency with advance warning of impending drug shortages.


MHRA has developed a new guidance document for Manufacturing Specials (MS) to ensure consistency during routine Good Manufacturing Practice (GMP) inspections and to ensure MS licence holders are aware of the authorities’ expectations in this complicated area.


The TGA has announced the launch of the Medical Device Single Audit Program (MDSAP) from January 2014, together with Brazil's ANVISA, Health Canada, and the US Food and Drug Administration FDA, to develop a global approach to auditing and monitoring the safe manufacturing of medical devices.

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