STAT
FEBRUARY 27, 2024
antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022. A much-anticipated inquiry by U.S.
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
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
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
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?
STAT
JUNE 20, 2023
Or they may share in the rebates that the PBMs pluck from pharmaceutical manufacturers — money that otherwise could be used by employers to lower premiums for their workers. Consulting firms and brokerages may receive a certain dollar amount for each covered employee and member.
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.
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