Tag: Quality Management Systems (QMS) in pharma

COFEPRIS GMP Standards and the Manufacture of Biologics in Mexico

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COFEPRIS GMP Standards and the Manufacture of Biologics in Mexico COFEPRIS GMP Standards and the Manufacture of Biologics in Mexico Introduction to COFEPRIS and GMP Regulations in Mexico In Mexico, the pharmaceutical industry is regulated by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which ensures that all pharmaceutical products meet the highest…

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GMP in Latin America (ANVISA, COFEPRIS)

Key Changes in Schedule M (Revised) GMP: What You Need to Know

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Key Changes in Schedule M (Revised) GMP: What You Need to Know Understanding the Key Changes in Schedule M (Revised) GMP Guidelines Introduction to Schedule M (Revised) India’s pharmaceutical sector is one of the largest globally, and its reputation depends heavily on adherence to stringent regulatory standards. The Schedule M (Revised) guidelines under the Drugs…

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SCHEDULE - M - Revised

TGA GMP Compliance for Small and Medium Pharma Companies in Australia

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TGA GMP Compliance for Small and Medium Pharma Companies in Australia Achieving TGA GMP Compliance for Small and Medium Pharmaceutical Companies in Australia Introduction to TGA GMP Compliance The Therapeutic Goods Administration (TGA) enforces Good Manufacturing Practice (GMP) standards to ensure the quality, safety, and efficacy of pharmaceutical products in Australia. For small and medium-sized…

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TGA GMP Guidelines

MHRA GMP Compliance for Small and Medium Pharmaceutical Companies

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MHRA GMP Compliance for Small and Medium Pharmaceutical Companies Achieving MHRA GMP Compliance for Small and Medium Pharmaceutical Companies Introduction to MHRA GMP Compliance For small and medium-sized pharmaceutical companies (SMEs), achieving and maintaining compliance with the Medicines and Healthcare products Regulatory Agency (MHRA) Good Manufacturing Practices (GMP) can be a daunting task. MHRA GMP…

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MHRA GMP Guidelines

How to Achieve WHO GMP Certification in Pharmaceutical Manufacturing

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How to Achieve WHO GMP Certification in Pharmaceutical Manufacturing A Step-by-Step Guide to Achieving WHO GMP Certification in Pharmaceutical Manufacturing Introduction to WHO GMP Certification The World Health Organization (WHO)’s Good Manufacturing Practices (GMP)) certification is a globally recognized standard that demonstrates a pharmaceutical manufacturer’s commitment to producing high-quality, safe, and effective medicines. Achieving WHO…

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WHO GMP Guidelines

PMDA GMP Guidelines for Biologics: Key Compliance Requirements

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PMDA GMP Guidelines for Biologics: Key Compliance Requirements PMDA GMP Guidelines for Biologics: Key Compliance Requirements Introduction to PMDA GMP Guidelines for Biologics Biologics, including vaccines, monoclonal antibodies, gene therapies, and recombinant proteins, are complex pharmaceutical products derived from living organisms. Due to the intricate nature of biologic manufacturing, ensuring the safety, efficacy, and quality…

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PMDA GMP Guidelines

The Impact of EMA GMP Standards on the Pharmaceutical Supply Chain

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The Impact of EMA GMP Standards on the Pharmaceutical Supply Chain How EMA GMP Standards Shape the Pharmaceutical Supply Chain Introduction to EMA GMP Standards and the Supply Chain The pharmaceutical supply chain is a complex network of processes involving the sourcing, production, storage, and distribution of medicinal products. The European Medicines Agency (EMA)’s Good…

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EMA GMP Guidelines

How to Prepare for a TGA GMP Inspection in Australia

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How to Prepare for a TGA GMP Inspection in Australia Comprehensive Guide to Preparing for a TGA GMP Inspection in Australia Introduction to TGA GMP Inspections The Therapeutic Goods Administration (TGA) conducts Good Manufacturing Practice (GMP) inspections to ensure pharmaceutical manufacturers comply with regulatory standards. These inspections are critical for maintaining product quality, safety, and…

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TGA GMP Guidelines

How to Prepare for an NMPA GMP Inspection

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How to Prepare for an NMPA GMP Inspection Preparing for an NMPA GMP Inspection: A Guide for Pharmaceutical Manufacturers Introduction to NMPA GMP Inspections The National Medical Products Administration (NMPA) is the regulatory authority responsible for ensuring that pharmaceutical products manufactured in China meet the highest standards of quality, safety, and efficacy. To maintain these…

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NMPA GMP Guidelines

How to Prepare for Schedule M (Revised) GMP Inspections in India

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How to Prepare for Schedule M (Revised) GMP Inspections in India Effective Preparation for Schedule M (Revised) GMP Inspections in India Understanding Schedule M (Revised) Inspections In the Indian pharmaceutical industry, Schedule M (Revised) under the Drugs and Cosmetics Act, 1940, establishes comprehensive guidelines for Good Manufacturing Practices (GMP). Regulatory inspections are a critical component…

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SCHEDULE - M - Revised