Inspections: Regulatory and procedural guidance

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See the full regulatory and procedural guidance index.

Table of contents


Good manufacturing practice and good distribution practice

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Document(s) Language Status First published Last updated Effective Date
Reflection paper on a proposed solution for dealing with minor deviations from the detail described in the marketing authorisation for human and veterinary medicinal products (English only)   06/01/2009    
Standard operating procedure for co-ordination of GCP inspections (English only) adopted 16/05/2007 27/09/2012 27/09/2012

Falsified medicines

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Good clinical practice

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Document(s) Language Status First published Last updated Effective Date
Reflection paper on advice to applicants/sponsors/CROS of bioequivalence studies (English only) adopted 19/09/2008    
Standard operating procedure for co-ordination of GCP inspections (English only) adopted 16/05/2007 27/09/2012 27/09/2012

Pharmacovigilance inspections

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Document(s) Language Status First published Last updated Effective Date
Procedure for coordinating pharmacovigilance inspections requested by the CHMP (English only) adopted 12/11/2007    
Procedure for conducting pharmacovigilance inspections requested by the CHMP (English only) adopted 12/11/2007    
Procedure for reporting of pharmacovigilance inspections requested by the CHMP (English only) adopted 12/11/2007    

Sampling and testing

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Product defects

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Document(s) Language Status First published Last updated Effective Date
Crisis Management regarding Defects of Centrally Authorised Products - Classification of Batch Recalls for Quality Defects (English only) adopted 03/07/2008    
Defective Product Report template (English only)   03/07/2008    
Standard operating procedure for dealing with reports of defective medicinal products (English only) adopted 01/04/2007 08/10/2012 08/10/2012

Certificates

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