Tag: Corrective and Preventive Actions (CAPA) for GMP

How COFEPRIS GMP Compliance Affects Pharmaceutical Product Development

December 20, 2024 digi

How COFEPRIS GMP Compliance Affects Pharmaceutical Product Development How COFEPRIS GMP Compliance Affects Pharmaceutical Product Development Introduction to COFEPRIS GMP and Pharmaceutical Development The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the regulatory authority responsible for overseeing the safety, quality, and efficacy of pharmaceutical products in Mexico. As part of its mandate,…

GMP in Latin America (ANVISA, COFEPRIS)

The Benefits of EMA GMP Certification for International Pharma Operations

December 20, 2024 digi

The Benefits of EMA GMP Certification for International Pharma Operations How EMA GMP Certification Drives Success in International Pharma Operations Introduction to EMA GMP Certification The European Medicines Agency (EMA)’s Good Manufacturing Practices (GMP)) certification is a globally recognized standard that ensures the quality, safety, and efficacy of pharmaceutical products. For pharmaceutical companies operating in…

EMA GMP Guidelines

The Role of MHRA GMP in Preventing Counterfeit Drugs

December 20, 2024 digi

The Role of MHRA GMP in Preventing Counterfeit Drugs How MHRA GMP Standards Help Prevent Counterfeit Drugs Introduction to Counterfeit Drugs and MHRA GMP Counterfeit drugs are a growing threat to global health, undermining the safety, efficacy, and trust in pharmaceutical products. These fake medicines often contain incorrect ingredients, improper dosages, or harmful substances, leading…

MHRA GMP Guidelines

The Role of NMPA GMP in Preventing Pharmaceutical Contamination

December 20, 2024 digi

The Role of NMPA GMP in Preventing Pharmaceutical Contamination The Role of NMPA GMP in Preventing Pharmaceutical Contamination Introduction to NMPA GMP and Pharmaceutical Contamination Pharmaceutical contamination can have serious consequences, ranging from compromised drug safety to severe public health risks. Contamination can occur at any stage of the pharmaceutical manufacturing process, including raw material…

NMPA GMP Guidelines

How TGA GMP Regulations Support Pharmaceutical Manufacturing Efficiency

December 20, 2024 digi

How TGA GMP Regulations Support Pharmaceutical Manufacturing Efficiency Enhancing Efficiency in Pharmaceutical Manufacturing Through TGA GMP Compliance Introduction to TGA GMP and Manufacturing Efficiency Efficiency in pharmaceutical manufacturing is critical for meeting market demands, reducing costs, and ensuring the timely delivery of high-quality medicines. The Therapeutic Goods Administration (TGA) in Australia enforces Good Manufacturing Practices…

TGA GMP Guidelines

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

December 20, 2024 digi

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…

WHO GMP Guidelines

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

December 20, 2024 digi

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…

SCHEDULE - M - Revised

How PMDA GMP Promotes Drug Quality Control in Japan

December 20, 2024 digi

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…

PMDA GMP Guidelines

Common ANVISA GMP Violations and How to Address Them

December 19, 2024 digi

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…

GMP in Latin America (ANVISA, COFEPRIS)

The Role of EMA GMP in the Manufacture of Orphan Drugs

December 19, 2024 digi

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)….

EMA GMP Guidelines