Tag: Pharmaceutical manufacturing under GMP

How MHRA GMP Standards Address Cross-Contamination Risks in Pharma

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How MHRA GMP Standards Address Cross-Contamination Risks in Pharma Addressing Cross-Contamination Risks with MHRA GMP Standards Introduction to Cross-Contamination and MHRA GMP Cross-contamination in pharmaceutical manufacturing occurs when one product is inadvertently contaminated with another during production, packaging, or storage. This poses significant risks to patient safety and product efficacy, making it a critical concern…

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MHRA GMP Guidelines

The Future of WHO GMP Guidelines and Their Impact on Global Pharma Manufacturing

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The Future of WHO GMP Guidelines and Their Impact on Global Pharma Manufacturing Exploring the Future of WHO GMP Guidelines and Their Role in Shaping Global Pharmaceutical Manufacturing Introduction to WHO GMP and Global Pharma Manufacturing The World Health Organization (WHO)’s Good Manufacturing Practices (GMP)) have long served as a cornerstone for ensuring the safety,…

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WHO GMP Guidelines

Best Practices for Ensuring COFEPRIS GMP Compliance in Mexican Pharmaceutical Operations

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Best Practices for Ensuring COFEPRIS GMP Compliance in Mexican Pharmaceutical Operations Best Practices for Ensuring COFEPRIS GMP Compliance in Mexican Pharmaceutical Operations Introduction to COFEPRIS GMP Compliance The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the regulatory body responsible for ensuring the safety, quality, and efficacy of pharmaceutical products in Mexico. COFEPRIS…

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GMP in Latin America (ANVISA, COFEPRIS)

Best Practices for Achieving and Maintaining Schedule M (Revised) GMP Compliance

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Best Practices for Achieving and Maintaining Schedule M (Revised) GMP Compliance Proven Strategies for Achieving and Sustaining Schedule M (Revised) GMP Compliance Introduction to Schedule M (Revised) GMP Compliance Schedule M (Revised) under the Drugs and Cosmetics Act, 1940, outlines comprehensive Good Manufacturing Practices (GMP) to ensure the safety, efficacy, and quality of pharmaceutical products…

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SCHEDULE - M - Revised

Best Practices for Ensuring NMPA GMP Compliance in China

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Best Practices for Ensuring NMPA GMP Compliance in China Best Practices for Ensuring NMPA GMP Compliance in China Introduction to NMPA GMP and Compliance in China In the pharmaceutical industry, Good Manufacturing Practices (GMP) are essential for ensuring that products are consistently produced and controlled according to quality standards. In China, the National Medical Products…

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NMPA GMP Guidelines

Best Practices for Ensuring PMDA GMP Compliance in Japan

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Best Practices for Ensuring PMDA GMP Compliance in Japan Best Practices for Ensuring PMDA GMP Compliance in Japan Introduction to PMDA GMP Compliance Good Manufacturing Practices (GMP) are essential to ensuring that pharmaceutical products are consistently produced and controlled to meet quality standards. In Japan, the Pharmaceutical and Medical Devices Agency (PMDA) enforces GMP regulations…

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PMDA GMP Guidelines

How TGA GMP Guidelines Help with the Stability and Shelf Life of Pharmaceuticals

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How TGA GMP Guidelines Help with the Stability and Shelf Life of Pharmaceuticals Ensuring Pharmaceutical Stability and Shelf Life with TGA GMP Guidelines Introduction to Stability and Shelf Life in Pharmaceuticals Pharmaceutical stability and shelf life are critical for ensuring the safety, efficacy, and quality of medicines over their intended use period. The Therapeutic Goods…

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TGA GMP Guidelines

How EMA GMP Standards Support Drug Manufacturing for Export to EU Markets

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How EMA GMP Standards Support Drug Manufacturing for Export to EU Markets Ensuring Compliance for Drug Exports to the EU with EMA GMP Standards Introduction to EMA GMP Standards and Drug Exports The European Medicines Agency (EMA)’s Good Manufacturing Practices (GMP)) serve as a critical regulatory framework for pharmaceutical manufacturers aiming to export drugs to…

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EMA GMP Guidelines

How to Stay Compliant with MHRA GMP Guidelines in UK Pharmaceutical Operations

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How to Stay Compliant with MHRA GMP Guidelines in UK Pharmaceutical Operations Maintaining Compliance with MHRA GMP Guidelines in Pharmaceutical Operations Introduction to MHRA GMP Compliance The Medicines and Healthcare products Regulatory Agency (MHRA) enforces Good Manufacturing Practices (GMP) to ensure the quality, safety, and efficacy of pharmaceutical products in the UK. Compliance with MHRA…

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MHRA GMP Guidelines

WHO GMP and the Role of Documentation and Record-Keeping

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WHO GMP and the Role of Documentation and Record-Keeping The Critical Role of Documentation and Record-Keeping in WHO GMP Compliance Introduction to Documentation in WHO GMP Documentation and record-keeping are cornerstones of the World Health Organization (WHO)’s Good Manufacturing Practices (GMP)) framework. They ensure traceability, accountability, and compliance in pharmaceutical manufacturing. Proper documentation serves as…

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WHO GMP Guidelines