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Annex 1 Compliance: Challenges, Solutions and International Impact (EU GMP & PIC/S)
Annex 1 Compliance: Challenges, Solutions and International Impact (EU GMP & PIC/S)

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.

  • Revision of Annex 1 taking a Risk based approach
  • Holistic (Collective effectiveness of Control and Monitoring measures documented in a CCS)
  • Proactive (more data trending a bio-analytics for more informed and real time data that avoid need for CAPAs 
  • Technology management for the Product Life cycle strategy
  • ICHQ12 compliance/ requirements for continuous improvement
  • EC Article 23 Directive
  • Understand the international relevance of the revised Annex 1 and the impact it is having on stakeholders together with 483 observations that have an Annex 1 ‘mind set’
  • Understand the significance of ICHQ9(R1) QRM revision that becomes effective around the same time as Annex 1 and how less subjectivity in Risk assessments can be applied to meet this revision
  • Bench mark what the challenges are that stakeholders are having to deal with considering requirements and clarity. What are the key topics of discussions at conferences and with CGMP guidance working groups.
  • Evaluate solutions presented to meet the revised Annex 1 Compliance
  • With Contamination Control Strategies prepared or incomplete bench mark against published CCS guidance to identify gaps or present a way forward to compliance
  • Understand what the expectations are for legacy facilities, equipment following Annex 1 becoming effective 25 August 2023
  • There is encouragement to new technologies and more real time monitoring systems in Annex 1, understand the status of implementation and remaining challenges for adoption

Annex 1 Compliance: Challenges, Solutions and International Impact (EU GMP & PIC/S)

New Dates TBA, Live Online Training
Regular price €1.850,00
Unit price
per 
James L. Drinkwater

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.

START TIMES

1:30 PM Vienna time

12:30 PM London time

8:30 AM New York time

5:30 AM Los Angeles time

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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.

  • Revision of Annex 1 taking a Risk based approach
  • Holistic (Collective effectiveness of Control and Monitoring measures documented in a CCS)
  • Proactive (more data trending a bio-analytics for more informed and real time data that avoid need for CAPAs 
  • Technology management for the Product Life cycle strategy
  • ICHQ12 compliance/ requirements for continuous improvement
  • EC Article 23 Directive
  • Understand the international relevance of the revised Annex 1 and the impact it is having on stakeholders together with 483 observations that have an Annex 1 ‘mind set’
  • Understand the significance of ICHQ9(R1) QRM revision that becomes effective around the same time as Annex 1 and how less subjectivity in Risk assessments can be applied to meet this revision
  • Bench mark what the challenges are that stakeholders are having to deal with considering requirements and clarity. What are the key topics of discussions at conferences and with CGMP guidance working groups.
  • Evaluate solutions presented to meet the revised Annex 1 Compliance
  • With Contamination Control Strategies prepared or incomplete bench mark against published CCS guidance to identify gaps or present a way forward to compliance
  • Understand what the expectations are for legacy facilities, equipment following Annex 1 becoming effective 25 August 2023
  • There is encouragement to new technologies and more real time monitoring systems in Annex 1, understand the status of implementation and remaining challenges for adoption

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Annex 1 Compliance: Challenges, Solutions and International Impact (EU GMP & PIC/S)

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