Qualification and Validation – public consultation on the revision of EU GMP Guidelines for Medicinal Products (EU GMP part I, Annex 15) launched

After discussion in the working groups in 2013, the DRAFT EU GMP guideline “Qualification and Validation” has entered into the next step being adopted as final draft for public consultation. The document reflects changes to other sections of the EU-GMP Guide such as Annex 11, ICH Q8, Q9, Q10, Q11 and changes in manufacturing technology. Besides the traditional approach to qualification and validation also other aspects such as product life cycle, critical process parameters (CPP), critical quality attributes (CQA), design space, continuous process verification etc. are being covered.

Direct link to the DRAFT EU guideline and other concerned documents:

GMP/GDP non compliance: where to look for reliable published facts?

Besides regulatory compliance, GMP (and also GDP) compliance is a must for pharmaceutical manufacturers. In this regard, there are different responsibilities assigned to the marketing authorization holder, the manufacturing authorization holder and the Qualified Person (QP), who is certifying GMP compliance of a particular batch of a medicinal product during batch release. Besides other items, this comprises the verification (by audits and other means, as far as applicable) of

  • GMP / GDP compliance of the MP manufacturer
  • GMP / GDP compliance of the API manufacturer
  • GDP compliance of the API distributer
  • excipients being suitable for use (“appropriate GMPs”).

Inspections of manufacturers by competent health authorities are regarded as important means in Europe to control, maintain and support the GMP compliance level. Besides own audits, how can the QP gather additional relevant information or where look for reliable published facts related to GMP / GDP compliance?
Such information is more and more published by the international health authorities (to be requested in writing or directly accessible) as listed hereunder:

EXCiPACT – The number of companies being certified according to this voluntary standard is constantly growing

EXCiPACT is a voluntary international scheme to provide independent 3rd party certification of manufacturers, suppliers and distributors of pharmaceutical excipients. The published list of companies being certified according to this voluntary standard is constantly growing and covers in the meantime 7 companies from 4 countries. In co-operation with Stuttgart based mdc GmbH, the auditors of blue inspection body GmbH have successfully conducted audits at 5 manufacturer sites.

Major GxP Events I & II/2014