Tag: Risk management in GMP

The Role of PMDA GMP in Preventing Pharmaceutical Contamination

December 19, 2024 digi

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)…

PMDA GMP Guidelines

How ANVISA GMP Helps with Drug Stability and Expiry Dates

December 19, 2024 digi

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…

GMP in Latin America (ANVISA, COFEPRIS)

How Schedule M (Revised) GMP Standards Affect the Pharmaceutical Supply Chain in India

December 19, 2024 digi

How Schedule M (Revised) GMP Standards Affect the Pharmaceutical Supply Chain in India The Impact of Schedule M (Revised) GMP Standards on India’s Pharmaceutical Supply Chain Introduction to Schedule M (Revised) and the Pharmaceutical Supply Chain The pharmaceutical supply chain is a complex network encompassing raw material procurement, manufacturing, storage, distribution, and delivery to end-users….

SCHEDULE - M - Revised

How EMA GMP Guidelines Impact Drug Stability and Shelf Life

December 19, 2024 digi

How EMA GMP Guidelines Impact Drug Stability and Shelf Life Ensuring Drug Stability and Shelf Life with EMA GMP Guidelines Introduction to Drug Stability and EMA GMP Guidelines Drug stability and shelf life are critical aspects of pharmaceutical manufacturing, directly affecting the efficacy, safety, and quality of medicinal products. The European Medicines Agency (EMA)’s Good…

EMA GMP Guidelines

The Importance of TGA GMP Documentation and Record Keeping

December 19, 2024 digi

The Importance of TGA GMP Documentation and Record Keeping Ensuring Compliance Through TGA GMP Documentation and Record Keeping Introduction to TGA GMP Documentation and Record Keeping Documentation and record-keeping are critical pillars of Good Manufacturing Practices (GMP) as enforced by the Therapeutic Goods Administration (TGA) in Australia. These practices ensure the safety, efficacy, and quality…

TGA GMP Guidelines

How MHRA GMP Compliance Affects Pharmaceutical Product Stability

December 19, 2024 digi

How MHRA GMP Compliance Affects Pharmaceutical Product Stability Ensuring Pharmaceutical Product Stability with MHRA GMP Compliance Introduction to Pharmaceutical Stability and MHRA GMP Pharmaceutical product stability is a critical aspect of drug development and manufacturing, ensuring that medicines remain safe, effective, and of high quality throughout their shelf life. The Medicines and Healthcare products Regulatory…

MHRA GMP Guidelines

Common WHO GMP Violations and How to Avoid Them

December 19, 2024 digi

Common WHO GMP Violations and How to Avoid Them Understanding Common WHO GMP Violations and Strategies to Avoid Them Introduction to WHO GMP Compliance Adhering to the World Health Organization (WHO)’s Good Manufacturing Practices (GMP)) is essential for ensuring the quality, safety, and efficacy of pharmaceutical products. However, achieving and maintaining compliance can be challenging,…

WHO GMP Guidelines

How to Leverage NMPA GMP for Regulatory Approvals in China

December 19, 2024 digi

How to Leverage NMPA GMP for Regulatory Approvals in China How to Leverage NMPA GMP for Regulatory Approvals in China Introduction to NMPA GMP and Regulatory Approvals in China The pharmaceutical industry in China is tightly regulated by the National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA). NMPA…

NMPA GMP Guidelines

How PMDA GMP Ensures Compliance in Pharma Manufacturing Operations

December 18, 2024 digi

How PMDA GMP Ensures Compliance in Pharma Manufacturing Operations How PMDA GMP Ensures Compliance in Pharma Manufacturing Operations Introduction to PMDA GMP Compliance in Pharmaceutical Manufacturing In the highly regulated pharmaceutical industry, ensuring that drug products are manufactured in accordance with Good Manufacturing Practices (GMP) is critical to ensuring their safety, efficacy, and quality. In…

PMDA GMP Guidelines

TGA GMP Compliance for Pharmaceutical Manufacturers Exporting to Australia

December 18, 2024 digi

TGA GMP Compliance for Pharmaceutical Manufacturers Exporting to Australia How Pharmaceutical Manufacturers Can Ensure TGA GMP Compliance for Export to Australia Introduction to TGA GMP Compliance for Export Pharmaceutical manufacturers exporting to Australia must adhere to the stringent Good Manufacturing Practices (GMP) standards enforced by the Therapeutic Goods Administration (TGA). These regulations ensure that imported…

TGA GMP Guidelines