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.
European Pharmaceutical Review
FEBRUARY 22, 2023
The Parenteral Drug Association (PDA)’s long-awaited Technical Report 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing is now available. Key features of the PDA TR 90 report The document addresses the evolution of contamination control principles towards a holistic approach.
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European Pharmaceutical Review
JULY 1, 2022
A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. To overcome these concerns, Pluta presents the process and documentation activities undertaken by one company.
European Pharmaceutical Review
AUGUST 25, 2023
The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision?
European Pharmaceutical Review
JULY 5, 2023
43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing. Specifically, the document covers the development process of glass containers for pharmaceutical products, glass container sampling as well as definition of lots.
European Pharmaceutical Review
MARCH 13, 2024
FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.
European Pharmaceutical Review
JULY 18, 2023
Most of the quality management systems providers are focusing on capturing these large pharmaceutical markets. Also noted in the report was the shift towards cloud-based systems.
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