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.
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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FDA Law Blog: Biosimilars
FEBRUARY 2, 2025
The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues.
Pharmaceutical Technology
APRIL 26, 2023
Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.
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.
European Pharmaceutical Review
APRIL 8, 2025
Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.
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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