Tag: GMP violations

TGA GMP for Over-the-Counter (OTC) Pharmaceutical Products

Posted on By digi

TGA GMP for Over-the-Counter (OTC) Pharmaceutical Products Ensuring Quality and Compliance in OTC Pharmaceuticals with TGA GMP Standards Introduction to TGA GMP for OTC Products Over-the-counter (OTC) pharmaceutical products play a crucial role in healthcare, offering consumers easy access to treatments for minor health conditions. In Australia, the Therapeutic Goods Administration (TGA) regulates OTC products…

Read More “TGA GMP for Over-the-Counter (OTC) Pharmaceutical Products” »

TGA GMP Guidelines

How to Improve GMP Compliance Using EMA Guidelines in Pharma

Posted on By digi

How to Improve GMP Compliance Using EMA Guidelines in Pharma Enhancing GMP Compliance with EMA Guidelines in the Pharmaceutical Industry Introduction to EMA GMP Guidelines and Compliance Good Manufacturing Practices (GMP) are the foundation of pharmaceutical manufacturing, ensuring product quality, safety, and efficacy. The European Medicines Agency (EMA) has established stringent GMP guidelines to regulate…

Read More “How to Improve GMP Compliance Using EMA Guidelines in Pharma” »

EMA GMP Guidelines

The Role of MHRA GMP in Managing Pharmaceutical Manufacturing Risks

Posted on By digi

The Role of MHRA GMP in Managing Pharmaceutical Manufacturing Risks How MHRA GMP Mitigates Risks in Pharmaceutical Manufacturing Introduction to Risk Management and MHRA GMP Pharmaceutical manufacturing is a complex process with inherent risks that can compromise product quality, safety, and efficacy. The Medicines and Healthcare products Regulatory Agency (MHRA) enforces Good Manufacturing Practices (GMP)…

Read More “The Role of MHRA GMP in Managing Pharmaceutical Manufacturing Risks” »

MHRA GMP Guidelines

How Schedule M (Revised) GMP Standards Support Generic Drug Manufacturing in India

Posted on By digi

How Schedule M (Revised) GMP Standards Support Generic Drug Manufacturing in India Enhancing Generic Drug Manufacturing in India with Schedule M (Revised) GMP Standards Introduction to Generic Drug Manufacturing in India India is renowned as the “pharmacy of the world,” with a significant share in the global generic drug market. Generic drugs provide affordable healthcare…

Read More “How Schedule M (Revised) GMP Standards Support Generic Drug Manufacturing in India” »

SCHEDULE - M - Revised

How ANVISA GMP Ensures Quality Control for Pharmaceuticals in Brazil

Posted on By digi

How ANVISA GMP Ensures Quality Control for Pharmaceuticals in Brazil How ANVISA GMP Ensures Quality Control for Pharmaceuticals in Brazil Introduction to ANVISA and the Role of GMP in Quality Control The National Health Surveillance Agency (ANVISA) is the regulatory authority in Brazil that is responsible for overseeing the safety, efficacy, and quality of pharmaceutical…

Read More “How ANVISA GMP Ensures Quality Control for Pharmaceuticals in Brazil” »

GMP in Latin America (ANVISA, COFEPRIS)

How NMPA GMP Helps Prevent the Production of Counterfeit Drugs

Posted on By digi

How NMPA GMP Helps Prevent the Production of Counterfeit Drugs How NMPA GMP Helps Prevent the Production of Counterfeit Drugs Introduction to NMPA GMP and Counterfeit Drugs Counterfeit drugs pose a significant threat to public health, as they can be ineffective, harmful, or even lethal to patients. In response to this growing problem, regulatory bodies…

Read More “How NMPA GMP Helps Prevent the Production of Counterfeit Drugs” »

NMPA GMP Guidelines

How TGA GMP Standards Support the Launch of New Pharmaceutical Products

Posted on By digi

How TGA GMP Standards Support the Launch of New Pharmaceutical Products The Role of TGA GMP Standards in Facilitating New Drug Launches Introduction to TGA GMP and Pharmaceutical Product Launches Launching a new pharmaceutical product is a complex process that requires rigorous planning, compliance, and quality assurance. The Therapeutic Goods Administration (TGA) in Australia enforces…

Read More “How TGA GMP Standards Support the Launch of New Pharmaceutical Products” »

TGA GMP Guidelines

Case Study: Achieving WHO GMP Certification in a Pharmaceutical Facility

Posted on By digi

Case Study: Achieving WHO GMP Certification in a Pharmaceutical Facility How a Pharmaceutical Facility Achieved WHO GMP Certification: A Case Study Introduction to WHO GMP Certification Achieving WHO GMP certification is a significant milestone for pharmaceutical manufacturers, signifying adherence to the highest standards of quality, safety, and efficacy. The certification not only builds trust among…

Read More “Case Study: Achieving WHO GMP Certification in a Pharmaceutical Facility” »

WHO GMP Guidelines

How to Integrate PMDA GMP with Other International Regulatory Requirements

Posted on By digi

How to Integrate PMDA GMP with Other International Regulatory Requirements How to Integrate PMDA GMP with Other International Regulatory Requirements Introduction to PMDA GMP and Global Regulatory Compliance The pharmaceutical industry operates in an increasingly globalized environment, with companies often marketing products in multiple countries and regions. For manufacturers, ensuring compliance with different regulatory requirements…

Read More “How to Integrate PMDA GMP with Other International Regulatory Requirements” »

PMDA GMP Guidelines

How EMA GMP Standards Promote Good Manufacturing Practices in Biotech

Posted on By digi

How EMA GMP Standards Promote Good Manufacturing Practices in Biotech Promoting Excellence in Biotech Manufacturing with EMA GMP Standards Introduction to EMA GMP Standards in Biotech Biotechnology is revolutionizing the pharmaceutical industry, enabling the development of complex therapies such as monoclonal antibodies, gene therapies, and cell-based treatments. Due to the intricate nature of these products,…

Read More “How EMA GMP Standards Promote Good Manufacturing Practices in Biotech” »

EMA GMP Guidelines