Course Description
Training course on achieving current GMP Compliance to EU GMP & PIC/S Annex 1 that became effective from 25 August 2023. The international relevance of Annex 1 is starting to become more apparent with the PICS Annex 1 that applies to 52 member countries of PICS: Pharmaceutic Inspection Co-operation Scheme, including the USA FDA and also with WHO involvement in Annex 1 revision drafting. In addition, 483 warning letters are starting to be issued with an Annex 1 ‘mindset’ although 483’s are based on CFR compliance.
Alongside Annex 1 revision the ICHQ9(R1) QRM has been revised to reduce subjectivity in risk assessments and cover risks in supply that impact product availability (drug shortage) plus ICHQ12 on Product Life Cycles considering regulatory and technical requirements was introduced. ICHQ12 included the term Established conditions (ECs) and in medicinal / therapeutic product manufacturing we now have to consider the Life cycle of environmental established conditions through Classification (ISO14644-1 – particles only), Qualification (Annex 1 microbial and particulate levels), Routine monitoring and Re-Qualification (Re-Certifications, Re-Calibration and Testing).
FDA have introduced initiatives around Quality metrics and Quality maturity where the effectiveness and adoption of a Pharmaceutical Quality System: PQS ICHQ10 is one of the key requirements to FDA metrics and Annex 1 so initiatives align. The impact and key points of ICH Guidance’s on CGMP compliance will be included.
Annex 1 presents challenges of new regulatory requirements, revised regulatory requirements (more to do) and in some requirements clauses lack clarity where understanding the regulatory intent is key to interpretation.
The training course focuses on the challenges and topics of impact presented by Annex 1 and considers solutions to meet current CGMP compliance that are being applied or considered to meet the effective Annex 1. Justifications for extensions to compliance to Annex 1 will be discussed.
Annex 1 Compliance: Challenges, Solutions and International Impact (EU GMP & PIC/S)
James L. Drinkwater is the current Head of GMP Compliance at Franz Ziel Germany. James is based in the UK for the global role and separately supports the Not-for-profit society: Pharmaceutical and Healthcare Sciences Society: PHSS an educational platform in GxP. James is the ex-Chairman (10 years) of the PHSS and currently Co-leads the Annex 1 and CCS Guidance focus groups.
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Course Description
Training course on achieving current GMP Compliance to EU GMP & PIC/S Annex 1 that became effective from 25 August 2023. The international relevance of Annex 1 is starting to become more apparent with the PICS Annex 1 that applies to 52 member countries of PICS: Pharmaceutic Inspection Co-operation Scheme, including the USA FDA and also with WHO involvement in Annex 1 revision drafting. In addition, 483 warning letters are starting to be issued with an Annex 1 ‘mindset’ although 483’s are based on CFR compliance.
Alongside Annex 1 revision the ICHQ9(R1) QRM has been revised to reduce subjectivity in risk assessments and cover risks in supply that impact product availability (drug shortage) plus ICHQ12 on Product Life Cycles considering regulatory and technical requirements was introduced. ICHQ12 included the term Established conditions (ECs) and in medicinal / therapeutic product manufacturing we now have to consider the Life cycle of environmental established conditions through Classification (ISO14644-1 – particles only), Qualification (Annex 1 microbial and particulate levels), Routine monitoring and Re-Qualification (Re-Certifications, Re-Calibration and Testing).
FDA have introduced initiatives around Quality metrics and Quality maturity where the effectiveness and adoption of a Pharmaceutical Quality System: PQS ICHQ10 is one of the key requirements to FDA metrics and Annex 1 so initiatives align. The impact and key points of ICH Guidance’s on CGMP compliance will be included.
Annex 1 presents challenges of new regulatory requirements, revised regulatory requirements (more to do) and in some requirements clauses lack clarity where understanding the regulatory intent is key to interpretation.
The training course focuses on the challenges and topics of impact presented by Annex 1 and considers solutions to meet current CGMP compliance that are being applied or considered to meet the effective Annex 1. Justifications for extensions to compliance to Annex 1 will be discussed.
Annex 1 Compliance: Challenges, Solutions and International Impact (EU GMP & PIC/S)
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