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.
Express Pharma
SEPTEMBER 13, 2024
Also, to establish a sense of transparency, especially for audits, and adhere to regulatory standards, manufacturers must have a Quality Management System (QMS) in place. This system assists in proper documentation and record-keeping.
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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
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.
Express Pharma
JUNE 12, 2024
With an impressive lineup of speakers and panelists, the summit promises deep insights into the evolving landscape of pharmaceutical manufacturing. The participants can gain deeper insights on recent focus areas such as Quality Management Maturity Models, Data and Documentation Imperative and Talent Capability Building.
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.
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.
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