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.
• 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.
• 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.