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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.

FDA 105
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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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How should cleaning validation sampling locations be chosen?

European Pharmaceutical Review

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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PDA revises report on glass container manufacturing

European Pharmaceutical Review

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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FDA warning letters highlight data integrity issues

European Pharmaceutical Review

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.

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QMS market to value nearly $4b by 2030

European Pharmaceutical Review

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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APL Health Care (Aurobindo )-Walk-In Interviews for IPQA/ Microbiology On 4th Feb’ 2023

Pharma Pathway

APL is a growing India multinational pharmaceutical manufacturing firm with turnover of over US$2.8 APL Health Care (Aurobindo )-Walk-In Interviews for IPQA/ Microbiology On 4th Feb’ 2023 Job Description Company Profile: Aurobindo Pharma Ltd’ (APL). Greetings from Aurobindo !!!