ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. In an attempt to address these challenges, in 2019 the ICH endorsed ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (and Annexes).

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Documentation FDA Communication Packaging 52

ISPE

MARCH 29, 2023

A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Online Exclusives A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

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Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

1 The European Commission (EC), the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S), and the WHO agreed to develop one common updated “Annex 1” for the manufacturing of sterile medicines. link] 3 Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

SEPTEMBER 12, 2022

Online Exclusives. Director, Office of Pharmaceutical Quality Operations. I'd like to concur that data integrity issues and poor data governance can be found in any sector of pharmaceutical manufacturing. Director, Office of Pharmaceutical Quality Operations. There is a lot of good engineering out there.

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