Tag: GMP in biopharmaceuticals

How to Address GMP Non-Conformities Identified in EMA Inspections

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How to Address GMP Non-Conformities Identified in EMA Inspections Steps to Address GMP Non-Conformities Identified During EMA Inspections Introduction to EMA GMP Inspections and Non-Conformities Good Manufacturing Practices (GMP) inspections by the European Medicines Agency (EMA) are critical for ensuring compliance with regulatory standards and safeguarding the quality of pharmaceutical products. However, even the most…

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EMA GMP Guidelines

How to Implement Lean Manufacturing in Compliance with Schedule M (Revised) GMP

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How to Implement Lean Manufacturing in Compliance with Schedule M (Revised) GMP Strategies to Implement Lean Manufacturing While Complying with Schedule M (Revised) GMP Introduction to Lean Manufacturing and Schedule M (Revised) Lean manufacturing is a methodology that focuses on minimizing waste and maximizing efficiency without compromising product quality. In the pharmaceutical industry, implementing lean…

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SCHEDULE - M - Revised

How MHRA GMP Supports the Manufacture of Orphan Drugs

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How MHRA GMP Supports the Manufacture of Orphan Drugs Understanding the Role of MHRA GMP in Orphan Drug Manufacturing Introduction to Orphan Drugs and MHRA GMP Orphan drugs are pharmaceutical products developed specifically to treat rare diseases or conditions, often affecting a small patient population. Due to the complexities involved in their development and manufacturing,…

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MHRA GMP Guidelines

GxP Compliance in Drug Manufacturing: What You Need to Know

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GxP Compliance in Drug Manufacturing: What You Need to Know Understanding GxP Compliance in Pharmaceutical Manufacturing Introduction: The Importance of GxP Compliance The pharmaceutical industry operates under stringent regulations to ensure that products meet the highest standards of safety, efficacy, and quality. At the heart of this regulatory framework is Good Practices (GxP), which encompasses…

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GMP vs. GxP (Good Practices)

WHO GMP and the Importance of Training and Education for Compliance

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WHO GMP and the Importance of Training and Education for Compliance The Role of Training and Education in Ensuring WHO GMP Compliance Introduction to WHO GMP and the Need for Training The World Health Organization (WHO)’s Good Manufacturing Practices (GMP)) are essential for ensuring the quality, safety, and efficacy of pharmaceutical products. Adhering to these…

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WHO GMP Guidelines

The Role of Sustainable Practices in TGA GMP Compliance

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The Role of Sustainable Practices in TGA GMP Compliance How Sustainable Practices Enhance TGA GMP Compliance in Pharmaceutical Manufacturing Introduction to Sustainability and TGA GMP Compliance Sustainability is becoming a critical focus in the pharmaceutical industry, where environmental responsibility aligns with regulatory requirements like Good Manufacturing Practices (GMP). The Therapeutic Goods Administration (TGA) in Australia…

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TGA GMP Guidelines

The Role of cGMP in Minimizing Risks in Pharmaceutical Manufacturing

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The Role of cGMP in Minimizing Risks in Pharmaceutical Manufacturing How cGMP Reduces Risks in Pharmaceutical Manufacturing Introduction to cGMP and Risk Management Current Good Manufacturing Practices (cGMP) are globally recognized regulatory standards that ensure pharmaceutical products are consistently manufactured to meet quality, safety, and efficacy requirements. Enforced by agencies like the FDA, EMA, and…

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What is cGMP?

How ANVISA GMP Guidelines Promote Drug Quality in Brazil

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How ANVISA GMP Guidelines Promote Drug Quality in Brazil How ANVISA GMP Guidelines Promote Drug Quality in Brazil Introduction to ANVISA and the Importance of GMP Guidelines The National Health Surveillance Agency (ANVISA) is the Brazilian regulatory body that ensures the safety, efficacy, and quality of pharmaceuticals in Brazil. As part of its mission to…

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GMP in Latin America (ANVISA, COFEPRIS)

PMDA GMP Compliance for Generic Drug Manufacturers

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PMDA GMP Compliance for Generic Drug Manufacturers PMDA GMP Compliance for Generic Drug Manufacturers Introduction to PMDA GMP and Generic Drug Manufacturing Generic drugs play a crucial role in the pharmaceutical industry, providing affordable alternatives to branded medications while maintaining the same efficacy and safety profiles. However, ensuring the quality and safety of generic drugs…

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PMDA GMP Guidelines

The Importance of Documentation and Record Keeping for EMA GMP Compliance

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The Importance of Documentation and Record Keeping for EMA GMP Compliance Ensuring EMA GMP Compliance Through Robust Documentation and Record Keeping Introduction to Documentation in EMA GMP Compliance Documentation and record keeping form the backbone of compliance with the European Medicines Agency (EMA)’s Good Manufacturing Practices (GMP)). These practices are essential for ensuring that pharmaceutical…

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EMA GMP Guidelines