Seminar series on the EU GMP Guide Annex 1

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In a series of webinars, the PTS Training Service presents the most important changes in the new draft of Annex 1 to the EU-GMP Guide.

In February 2020, the second draft of the revised EU-GMP Annex 1 for the manufacture of sterile medicinal products was published. This is open for consultation until July 20, 2020. Selected organizations and stakeholders can comment on the current draft using a questionnaire.

Since 2017, many companies have started implementing the draft. The new draft has again changed numerous passages, embedding individual sentences into other predefined points - what still applies now?

To address this, PTS offers this webinar series, which shows what has changed.

Webinar: Annex 1 and CCS

Contamination Control Strategy
Contamination Control Strategy CCS
Impact on the manufacture of sterile products

Content
• Key elements that make up the CCS
• Impact of the continuous principle in Annex 1
• Effects of the CCS on: construction and equipment, process, personnel, cleaning and disinfection, sterilization, environmental monitoring, media fill
• Workshop

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Webinar: Annex 1 and Manufacturing Management

Impact of Annex 1 on Manufacturing Management
New for sterile product manufacturing
GMP update for re-qualification

Content
• The role of Manufacturing Management (LdH) in the new Annex 1
• What does: adequate knowledge and experience in the manufacture of sterile dosage forms and their critical quality attributes mean?
• Tasks and responsibilities of the LdH in the new Annex 1
• Batch control within the framework of the contamination control strategy
• Use of new (digital) technologies – what must the QP consider?
• Effects of the CCS on manufacturing management
• Quality control

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Webinar: Annex 1 - Sterilization of Medicinal Products, Active Substances, Excipients, Packaging Materials

Annex 1 and Sterilization Processes
EMA Guideline for the sterilization of medicinal products, active substances, excipients, and primary containers
Selection and suitability of sterilization processes

Content
• Quality dossier (definitions, requirements, validation)
• Dry heat sterilization
• Depyrogenation with dry heat
• Sterilization by filtration
• Aseptic manufacturing
• Active substances and excipients
• Containers and packaging

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Webinar: Annex 1 - Meet your Expert

With a focus on technical aspects
Up-to-date: Annex 1 - not revised, but newly created
Cleanrooms, equipment
Room air technology

Content
• Brief summary of Part 1: CCS, PQS, personnel, production, technology, quality control
• Buildings, cleanrooms, layouts, cleanroom classification
• Equipment and instrumentation
• Utilities and room air technology
• Monitoring
• Media fill

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