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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. The Importance of Adhering to WHO Guidelines Adherence to WHO guidelines for BMRs is essential for ensuring the quality, safety, and efficacy of pharmaceutical products.

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Streamlining Compliance in the Pharmaceutical Industry with the eQMS

Dot Compliance

In the pharmaceutical industry, the importance of regulatory compliance extends beyond fulfilling legal obligations. Compliance can be streamlined with the help of an electronic quality management system (eQMS) that incorporates regulatory standards into every operational aspect of a pharmaceutical organization.

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What is CAPA in the Pharmaceutical Industry?

Dot Compliance

A good CAPA system is critical to the pharmaceutical industry. It helps ensure product quality, patient safety, regulatory compliance and more. Regulatory Compliance Adherence to regulatory requirements, such as those outlined by the FDA’s 21 CFR Part 820, is mandatory for pharmaceutical manufacturers.

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What is CAPA in the Pharmaceutical Industry?

Dot Compliance

A good CAPA system is critical to the pharmaceutical industry. It helps ensure product quality, patient safety, regulatory compliance and more. Regulatory Compliance Adherence to regulatory requirements, such as those outlined by the FDA’s 21 CFR Part 820, is mandatory for pharmaceutical manufacturers.

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CAPA: Seven Steps for an Effective Process

Dot Compliance

In the pharmaceutical industry, a leading Corrective and Preventive Action (CAPA) process is essential for ensuring product quality and regulatory compliance. Step 3: Risk Assessment Assess the potential impact of the identified problem on product quality, patient safety, and regulatory compliance.

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Pharma – 2025 Health IT Predictions

Healthcare IT Today

Check out our community’s Pharma predictions: Dave Latshaw, CEO at BioPhy The competitive dynamics of the pharmaceutical industry will undergo substantial reorganization in 2025. The pharmaceutical industry is poised for a transformative shift in 2025, with artificial intelligence becoming deeply embedded in core operations.

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Everything You Need to Know about Batch Manufacturing Record (BMR) Reviews

Dot Compliance

These records are essential for ensuring consistency, safety, and compliance in the pharmaceutical industry. Document retention: Ensure that BMRs and related documents are retained for the required period, as specified by regulatory requirements.