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STAT+: FTC says pharmacy benefit managers are stonewalling requests for information

STAT

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.

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Continuous manufacturing: Changing the paradigm in the pharmaceutical manufacturing sector

Express Pharma

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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Strategic EPCIS Implementation: Optimizing Supply Chain Management through Strategic EPCIS Implementation

Pharmaceutical Commerce

This document outlines key strategies and testing protocols critical for optimizing EPCIS implementation, ensuring that pharmaceutical manufacturers can maintain compliance and operational efficiency.

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Drop Shipment Efficiency: Navigating Data Challenges in Indirect Partner Transactions

Pharmaceutical Commerce

This document details the benefits of DataX, a revolutionary solution tailored for pharmaceutical manufacturers. Designed to navigate the complexities of managing serialized data for drop shipments, DataX ensures secure, compliant, and efficient data exchange.

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IPA to host 9th Global Pharmaceutical Quality Summit

Express Pharma

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.

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PDA releases contamination control strategy report

European Pharmaceutical Review

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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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

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.