EU Annex 1 - Manufacture of Sterile Medicinal Products

New draft released February 2020

The new version of Annex 1 has major updates, in both structure and content.
This session guides you through the changes, point by point.

Course description

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

Course outline

Point on Eu and US cGMPs on sterile productions.
Study on major differences between the new draft, the draft published in 2017 and the 2008 version
Study of all the points of the new draft chapters:

• Scope and Principle: Reinforcement of the specific terminology CCS (Contamination Control Strategy)
• Pharmaceutical Quality System (PQS) and requirement for an effective risk management system integrated into the product life cycle
• Premises: Focus on Barrier Technologies Systems (Isolators and RABS) – Cleanroom and cleanair equipment qualification – Disinfection
• Equipment
• Utilities: Focus on Water Systems
• Personnel: Focus on the Qualification of the personnel
• 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.
• Viable and non-viable environmental and process monitoring: Particular Focus on Aseptic Process Simulation
• Quality control (QC)

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

Learning objectives

The main objective of this session is to have an exhaustive overview and comprehension of the new draft of the Annex 1 published on February 2020.

Who should attend

This training is intended for personnel categories such as Quality Assurance, Sterility Assurance, Production, Facilities, Engineering, Auditors, Qualified Persons and all support functions involved in contamination in sterile environments.

#5230