Your Variation Identification Agent for Post Approval Change Management Watch Via in Action
March 2026The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has opened public consultations on proposed updates to GMP Annex 6 and Annex 15, aiming to align manufacturing standards with modern industry practices and quality risk management.
Annex 6 (Manufacture of Medicinal Gases) focuses on updating guidelines to reflect new technologies, digital systems, and current production practices. The consultation runs from 11 February to 11 April 2026.
Annex 15 (Qualification and Validation) proposes expanding scope to include active substance manufacturers and aligning with ICH Q9 (R1) on quality risk management. The consultation period is 09 February to 09 April 2026.
Stakeholders, including Australian manufacturers, are encouraged to submit feedback via the PIC/S EU Survey tool. The TGA adopts these annexes under its Manufacturing Principles, making participation important for regulatory alignment.
These revisions aim to enhance GMP compliance, validation practices, and global harmonization in pharmaceutical manufacturing.
Region: Australia
Source: https://www.tga.gov.au/news/news-articles/gmp-annex-6-and-annex-15-concept-papers-open-public-consultation
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