GMP 2: Recent Changes in GMP Guidelines

21 September 2018
Comments 2
21 September 2018, Comments 2

In the first post of the series we introduced the concept of GMP and its transformation from its inception to the present day. Today we will look at examples of the recent changes introduced in the derived guidelines due to this change in paradigm.

As a consequence of the work performed at ICH level, the EUGMP and collateral guidances issued by governmental and non-governmental entities are in process of changing, adapting their contents to the new approach. The main changes introduced are summarized consecutively:

New Annex 15 of EUGMP (Validation), Applicable to medicinal products manufacturing and optional to API manufacturing. October 2015.

New Chapter 3 of EUGMP Part I (Premises and equipment) Applicable to medicinal products manufacturing. March 2015.

New Chapter 5 of EUGMP Part I (Production). Applicable to medicinal products manufacturing: March 2015.

New Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities Applicable to medicinal products manufacturing.  EUGMP Part III. June 2015.

Official Journal of the European Union. Guidelines of 19 March 2015 on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use. (2015/C 95/02). EUGMP Part III . March 2016.

MHRA ‘GXP’ Data Integrity Guidance and Definitions.  March 2018 (second version).

Data Integrity and Compliance with CGMP. Guidance for Industry. Draft April 2016.

Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use . November 2013.

Official Journal of the European Union. Guidance of 19 March 2015 on principles of Good Distribution Practice (GDP) of active substances for medicinal products for human use.  September 2015.

GAMP 5 GUIDE: Compliant GxP Computerized Systems (ISPE 2008).

IPEC. Good Manufacturing Practices for pharmaceutical excipients (2017).

Annex 16: Certification by a Qualified Person and Batch Release. Updated April 2016.

ICH Q3D. Elemental impurities (2014).

Submission of Quality Metrics Data Guidance for Industry. Draft November 2016.

Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. May 2018.

APIC Guide For Auditing Registered Starting Material Manufacturers Version February, 2018.


These guidelines, analysed in conjunction with the concept of GMP as a cultural framework within the organisation, will be of great help in understanding the concepts outlined by ICH.

In the following posts we will continue to study in depth issues related to the change of paradigm in GMP, trying to provide our vision of the subject and generating added value for readers.

2 responses on “GMP 2: Recent Changes in GMP Guidelines

  1. Roger says:

    Interessant blog. Suposo que anireu afegint després interpretacions de les guies, els canvis i que implica. És un dels mal de caps del sector.
    Pel que em vaig trobant, l’annexe 16, la ICH Q3D i el concepte de continuous process verification són els que més mal de caps estan portant al sector.
    Per últim, només afegir que trobo a falta el nou esborrany de l’annex 1 de productes estèrils, i que està en modificació actualment:

    • AFA says:

      Dear Roger,

      Thank you very much for your interest and for your comment.

      Indeed, the objective of this first series is to establish the context of the change in paradigm. Future entries will go deeper into the interpretation and consequences.
      Trending topics, such as Elemental Impurities, Serialization, Data Integrity and the concept of Continuous Process Verification, will for sure be included in future posts.

      Last, but not least, regarding the Manufacture of Sterile Medicinal Products, we preferred not to include the guide at this moment as is still under discussion and some major changes are still possible. In any case, this will surely be a topic to include in future discussions.

      Best regards.