EU Annex 1 – Manufacture of Sterile Medicinal Products

The new version of the GMPs Annex 1 published by the European Commission on 22 08 2022 has major updates, in both its structure and its content. This session guides you through the main new requirements by explaining change of Mindset (Quality Assurance and Sterility Assurance based on Quality Risk Management Approach), supporting by the international experience of the trainer specialized on coaching for preparation of audits and inspections of numerous Sterile Pharmaceutical Companies.

Course description

This interactive training will be supported by many examples and group discussions around Sterile manufacturing issues. The new version of EMA Annex 1 of Eudralex vol. 4 will accurately reviewed and each new expectation will be deciphered and analyzed to be translated into operational terms.

Course outline

Passing in Review all the chapters by focusing on main topics and identifying operational impact of these regulatory change:

• Scope and Principle:
  General Approach, Mindset, Quality Risk Management and CCS (Design, Control, Execution, Monitoring, Testing and Quality Continuous Improvement)
• Pharmaceutical Quality System (PQS):
  Sterility Assurance, Quality of Investigation for critical issues, Batch Impact, Skills of Batch Release Team

• Premises:
  • Barrier Technologies (Isolator and RABS)
  • Cleanroom Qualification
  • Decontamination Process (Cleaning and Disinfection)

• Equipment:
  • Indirect Contact Parts and Management, Maintenance interventions and Design of Equipment

• Utilities:
  • This chapter will be review in details because all the requirements inside are new. That’s the first time for example discussing about Biofilm.

• Personnel:
  • Qualification, behavior & Subcontracting activities for gowning grade by grade

• Production and Specific Technologies:
  For this section, the speakers will be able to adapt their speaking to answer to the specific cases of all the participants.
  At least Discussion around:
  • Terminal Sterilization vs Aseptic Process (Main Differences and specificities)
  • Sterilizing Filtration and PUPSIT
  • Lyophilization
  • Closed Systems and SUS

• Environmental Monitoring:
  • Risk Analysis
  • Trend Analysis
  • How to interpret results?
  • Strategy for identification

• Aseptic Process Simulation:
  • APS Design
  • Inherent and corrective Actions
  • Positioning APS in term of Sterility Assurance

• Quality control (QC) :
  • Sterility Test
  • Management of Raw Materials
  • Microbiological Laboratory Activities

The course will be illustrated from specific situations met by the speakers in Pharmaceutical companies.

Learning objectives

The course will be illustrated from specific situations met by the speaker in Pharmaceutical companies.

The main objective of this session is to have an exhaustive overview and a full understanding of the position of European inspectors and auditors regarding the new Annex 1.

Who should attend

This training is intended for Company Executives and Managers of Department involved such as Quality Assurance, Sterility Assurance, Production, Facilities, Engineering, Auditors, Qualified Persons and all support functions involved in Contamination Control Strategy.

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