Tag: MHRA GMP requirements

WHO GMP Standards and the Role of CAPA (Corrective and Preventive Actions)

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WHO GMP Standards and the Role of CAPA (Corrective and Preventive Actions) Understanding WHO GMP Standards and the Role of CAPA in Pharmaceutical Quality Management Introduction to WHO GMP and CAPA Corrective and Preventive Actions (CAPA) are an integral part of the World Health Organization (WHO)’s Good Manufacturing Practices (GMP)). CAPA systems are designed to…

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WHO GMP Guidelines

How to Train Your Staff to Meet Schedule M (Revised) GMP Requirements

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How to Train Your Staff to Meet Schedule M (Revised) GMP Requirements Effective Training Strategies to Ensure Compliance with Schedule M (Revised) GMP Standards Introduction to Staff Training and Schedule M (Revised) The successful implementation of Schedule M (Revised) Good Manufacturing Practices (GMP) relies heavily on a well-trained workforce. Staff at all levels of a…

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SCHEDULE - M - Revised

How PMDA GMP Promotes Drug Quality Control in Japan

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How PMDA GMP Promotes Drug Quality Control in Japan How PMDA GMP Promotes Drug Quality Control in Japan Introduction to PMDA GMP and Drug Quality Control Drug quality control is essential to ensure that pharmaceutical products meet safety, efficacy, and quality standards before reaching consumers. In Japan, the Pharmaceutical and Medical Devices Agency (PMDA) enforces…

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PMDA GMP Guidelines

Common ANVISA GMP Violations and How to Address Them

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Common ANVISA GMP Violations and How to Address Them Common ANVISA GMP Violations and How to Address Them Introduction to ANVISA GMP Violations The National Health Surveillance Agency (ANVISA) is the regulatory body responsible for ensuring the safety, quality, and efficacy of pharmaceutical products in Brazil. One of the primary ways ANVISA enforces its regulatory…

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GMP in Latin America (ANVISA, COFEPRIS)

The Role of EMA GMP in the Manufacture of Orphan Drugs

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The Role of EMA GMP in the Manufacture of Orphan Drugs Ensuring Quality and Compliance in the Manufacture of Orphan Drugs with EMA GMP Introduction to Orphan Drugs and EMA GMP Standards Orphan drugs are pharmaceutical products developed to treat rare diseases, often affecting fewer than 1 in 2,000 people in the European Union (EU)….

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EMA GMP Guidelines

How TGA GMP Helps Prevent Counterfeit Drugs in Australia

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How TGA GMP Helps Prevent Counterfeit Drugs in Australia The Role of TGA GMP in Combating Counterfeit Drugs in Australia Introduction to Counterfeit Drugs and TGA GMP Counterfeit drugs pose a significant threat to public health, undermining patient safety and the integrity of the pharmaceutical industry. These falsified medicines may lack active ingredients, contain harmful…

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TGA GMP Guidelines

How NMPA GMP Guidelines Support Sustainable Practices in Pharma Manufacturing

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How NMPA GMP Guidelines Support Sustainable Practices in Pharma Manufacturing How NMPA GMP Guidelines Support Sustainable Practices in Pharma Manufacturing Introduction to NMPA GMP and Sustainability in Pharma Manufacturing The pharmaceutical industry is facing growing pressure to adopt sustainable practices in response to environmental concerns, resource limitations, and increasing regulatory expectations. In China, the National…

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NMPA GMP Guidelines

How WHO GMP Compliance Supports Pharmaceutical Supply Chains

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How WHO GMP Compliance Supports Pharmaceutical Supply Chains The Role of WHO GMP Compliance in Strengthening Pharmaceutical Supply Chains Introduction to WHO GMP and Supply Chains The pharmaceutical supply chain is a complex network that includes raw material suppliers, manufacturers, distributors, and healthcare providers. Ensuring the safety, quality, and efficacy of medicines across this chain…

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WHO GMP Guidelines

The Role of PMDA GMP in Preventing Pharmaceutical Contamination

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The Role of PMDA GMP in Preventing Pharmaceutical Contamination The Role of PMDA GMP in Preventing Pharmaceutical Contamination Introduction to Pharmaceutical Contamination and PMDA GMP Pharmaceutical contamination is a serious risk that can undermine the safety, efficacy, and quality of drug products, potentially endangering patient health. In Japan, the Pharmaceutical and Medical Devices Agency (PMDA)…

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PMDA GMP Guidelines

How ANVISA GMP Helps with Drug Stability and Expiry Dates

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How ANVISA GMP Helps with Drug Stability and Expiry Dates How ANVISA GMP Helps with Drug Stability and Expiry Dates Introduction to ANVISA GMP and Drug Stability The National Health Surveillance Agency (ANVISA) is Brazil’s regulatory body responsible for overseeing the safety, quality, and efficacy of pharmaceutical products. One of the key frameworks enforced by…

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GMP in Latin America (ANVISA, COFEPRIS)