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Understanding WHO Guidelines for Batch Manufacturing Records

Dot Compliance

The World Health Organization (WHO) has established guidelines for BMRs to ensure consistency, quality, and safety across the global pharmaceutical industry. By following these guidelines, manufacturers can: Protect public health: Ensure that the products they produce are safe and effective for use.

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SQA Regulatory Surveillance Summary for January and February 2024

SQA

A health professional, in the context of a directed donation, did not create a document stating that, in their medical opinion, the use of sperm or ova would not pose a serious risk to human health and safety. Now the Ministry of Health has published revised regulations in accordance with Annex M of the Drugs and Cosmetics Rules.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – May

SQA

88, Microbial Data Deviation Investigations in the Pharmaceutical Industry, January 2022. World Health Organization (WHO). WHO Pharmaceuticals Newsletter, No. PDA Technical Report No. PDA Technical Report No. 88 presents a holistic approach for performing a microbiological investigation.

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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies. The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot.

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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies.The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices,were verifiedon the spot.

FDA 40