Tag: MHRA GMP requirements

The Impact of ANVISA GMP on the Brazilian Pharmaceutical Market

Posted on By digi

The Impact of ANVISA GMP on the Brazilian Pharmaceutical Market The Impact of ANVISA GMP on the Brazilian Pharmaceutical Market Introduction to ANVISA and the Role of GMP in Brazil The National Health Surveillance Agency (ANVISA) is Brazil’s regulatory body responsible for ensuring the safety, quality, and efficacy of pharmaceutical products, including drugs, medical devices,…

Read More “The Impact of ANVISA GMP on the Brazilian Pharmaceutical Market” »

GMP in Latin America (ANVISA, COFEPRIS)

How to Prepare for EMA GMP Inspections in Multi-Site Pharmaceutical Operations

Posted on By digi

How to Prepare for EMA GMP Inspections in Multi-Site Pharmaceutical Operations Comprehensive Guide to Preparing for EMA GMP Inspections Across Multi-Site Pharmaceutical Operations Introduction to EMA GMP Inspections Ensuring compliance with the European Medicines Agency (EMA)’s Good Manufacturing Practices (GMP)) is essential for pharmaceutical companies operating across multiple sites. EMA GMP inspections assess whether manufacturing…

Read More “How to Prepare for EMA GMP Inspections in Multi-Site Pharmaceutical Operations” »

EMA GMP Guidelines

How Schedule M (Revised) GMP Helps with Drug Stability and Shelf Life

Posted on By digi

How Schedule M (Revised) GMP Helps with Drug Stability and Shelf Life Ensuring Drug Stability and Shelf Life Through Schedule M (Revised) GMP Guidelines Introduction to Drug Stability and Shelf Life Drug stability and shelf life are critical parameters in pharmaceutical manufacturing. They ensure that a drug maintains its intended efficacy, safety, and quality throughout…

Read More “How Schedule M (Revised) GMP Helps with Drug Stability and Shelf Life” »

SCHEDULE - M - Revised

The Role of WHO GMP in Regulatory Approvals for Emerging Markets

Posted on By digi

The Role of WHO GMP in Regulatory Approvals for Emerging Markets How WHO GMP Guidelines Facilitate Regulatory Approvals in Emerging Markets Introduction to WHO GMP and Emerging Markets Emerging markets are rapidly becoming vital players in the global pharmaceutical industry, driven by growing healthcare demands and expanding manufacturing capabilities. However, gaining regulatory approval in these…

Read More “The Role of WHO GMP in Regulatory Approvals for Emerging Markets” »

WHO GMP Guidelines

How to Ensure GMP Compliance with MHRA Guidelines for Biologics

Posted on By digi

How to Ensure GMP Compliance with MHRA Guidelines for Biologics Ensuring GMP Compliance with MHRA Guidelines for Biologics Introduction to MHRA GMP Guidelines for Biologics Biologics, or biopharmaceuticals, are complex medicinal products derived from living organisms. These include vaccines, monoclonal antibodies, gene therapies, and cell-based products. Due to their intricate nature and sensitivity to environmental…

Read More “How to Ensure GMP Compliance with MHRA Guidelines for Biologics” »

MHRA GMP Guidelines

The Role of Technology in Achieving NMPA GMP Compliance

Posted on By digi

The Role of Technology in Achieving NMPA GMP Compliance The Role of Technology in Achieving NMPA GMP Compliance Introduction to NMPA GMP and Technology The pharmaceutical industry is one of the most highly regulated sectors globally, with strict standards in place to ensure the safety, efficacy, and quality of drugs. In China, the National Medical…

Read More “The Role of Technology in Achieving NMPA GMP Compliance” »

NMPA GMP Guidelines

How to Achieve GMP Compliance in TGA Regulated Clinical Trials

Posted on By digi

How to Achieve GMP Compliance in TGA Regulated Clinical Trials Ensuring GMP Compliance in TGA-Regulated Clinical Trials Introduction to GMP Compliance in Clinical Trials Clinical trials are critical for evaluating the safety and efficacy of new pharmaceutical products. The Therapeutic Goods Administration (TGA) in Australia enforces stringent Good Manufacturing Practices (GMP) to ensure the quality,…

Read More “How to Achieve GMP Compliance in TGA Regulated Clinical Trials” »

TGA GMP Guidelines

PMDA GMP Guidelines for the Manufacture of Injectable Drugs

Posted on By digi

PMDA GMP Guidelines for the Manufacture of Injectable Drugs PMDA GMP Guidelines for the Manufacture of Injectable Drugs Introduction to PMDA GMP and Injectable Drugs Injectable drugs are among the most critical pharmaceutical products, as they are administered directly into the body, often for serious medical conditions. The safety and efficacy of injectable drugs depend…

Read More “PMDA GMP Guidelines for the Manufacture of Injectable Drugs” »

PMDA GMP Guidelines

How COFEPRIS GMP Guidelines Address the Issue of Counterfeit Drugs in Mexico

Posted on By digi

How COFEPRIS GMP Guidelines Address the Issue of Counterfeit Drugs in Mexico How COFEPRIS GMP Guidelines Address the Issue of Counterfeit Drugs in Mexico Introduction to COFEPRIS and the Counterfeit Drug Problem The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the regulatory body responsible for ensuring the safety, quality, and efficacy of…

Read More “How COFEPRIS GMP Guidelines Address the Issue of Counterfeit Drugs in Mexico” »

GMP in Latin America (ANVISA, COFEPRIS)

How EMA GMP Standards Promote Sustainability in Pharmaceutical Manufacturing

Posted on By digi

How EMA GMP Standards Promote Sustainability in Pharmaceutical Manufacturing Sustainability in Pharmaceutical Manufacturing with EMA GMP Standards Introduction to Sustainability and EMA GMP Standards Sustainability has become a critical consideration in pharmaceutical manufacturing as the industry seeks to reduce its environmental footprint while maintaining high standards of quality and safety. The European Medicines Agency (EMA)’s…

Read More “How EMA GMP Standards Promote Sustainability in Pharmaceutical Manufacturing” »

EMA GMP Guidelines