Document Documentation Packaging 
Express Pharma
DECEMBER 23, 2024
He also discussed the importance of having retention samples for raw materials and packaging materials and the role of quality control in investigating deviations and ensuring the stability of raw materials. He also stressed the importance of reviewing batch records and analytical records and the need for clear documentation practices.
Express Pharma
DECEMBER 30, 2024
He further highlighted the importance of thorough documentation, communication with regulators, and the need for a comprehensive understanding of the revised Schedule M guidelines.
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Drug Patent Watch
JANUARY 22, 2025
I'm talking about Good Manufacturing Practice (GMP), a set of guidelines that govern the production, testing, and packaging of generic drugs. Documentation and record-keeping : Manufacturers must maintain accurate and detailed records of their manufacturing processes, including batch records, quality control records, and training records.
FDA Law Blog: Biosimilars
APRIL 10, 2025
Documents that FDA discloses in response to FOIA requests can vary widely, from inspectional documents, like Form 483s and Establishment Inspection Reports, to correspondence between FDA and sponsors, and can be voluminous, such as 510(k) documents and other review memos.
European Pharmaceutical Review
JANUARY 25, 2024
This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.
GMPSOP
OCTOBER 16, 2022
Table of Contents Good documentation practice requires a system for control, implementation, maintenance and archival of GMP related documents and records. To implement good documentation practice and systems the site must assure that GMP documents and records are adequate, approved and in compliance with applicable GMP requirements.
European Pharmaceutical Review
AUGUST 23, 2022
Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively. Overall, validation, documentation and quality control were the major cGMP violations.
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