Preparation for regulatory inspections
Essential reading of regulations, directives and guidelines that reflect best practice.
This is the first annual update to the ‘Guidance for pharmaceutical distributors 2015’ (published by Pharmaceutical Press, owned by the Royal Pharmaceutical Society) since the EU regulation 2013/C 343/01 was passed. Known as the ‘green guide’, it was compiled by the Inspection Enforcement and Standards Division of the Medicines and Healthcare products Regulatory Agency and provides an outline from the official EU regulations, directives and guidelines that reflect best practice to ensure the quality of medicines supplied to patients.
For anyone involved in the distribution and brokering of medicines and medical devices, this is vital information. The guide presents 12 revisions to the EU Good Distribution Practice, which introduces the requirement for compliance with quality management systems in distribution practice — essential to maintaining the quality of medicines and medical devices — in order to mitigate the risk of counterfeit medicines entering the European supply chain.
New to this edition is the gold standard for responsible persons of which the duties and responsibilities are listed. The gold standard also requires an understanding of technical competence and knowledge, business improvement techniques and guidance on functional behaviour. These latter points are new to training courses for the responsible person, and are useful when implementing the actions resulting from the release or failure of a batch of medicine, particularly if these actions have commercial consequences.
There is also a section on implementing surveillance necessary to prevent falsified medicines entering the supply chain, an essential requirement for the implementation of the Falsified Medicines directive 2011/62.
The section on best practice in temperature monitoring is also useful because ambient temperatures can vary considerably. Regions that were once considered to be temperate are now subtropical, particularly in parts of the extended European market.
Readers should note that all the information in the green guide is duplicated in the ‘Rules and guidance for pharmaceutical manufacturers and distributors 2015’, known as the ‘orange guide’. On the whole, the orange guide has little new information compared with the 2014 edition, so for anyone who already has this, the green guide would be a more sensible purchase.
Although the green guide is a summary of existing published European regulatory papers, it is comprehensive and the reader would be hard pressed to find a similar list elsewhere. This book is essential reading when preparing for any regulatory inspection.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067814
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