Tag: Risk management in GMP

Best Practices for GMP Compliance in Clinical Trials in Asia

May 15, 2025 digi

Best Practices for GMP Compliance in Clinical Trials in Asia GMP Compliance in Clinical Trials: Best Practices in Asia Introduction to GMP Compliance in Clinical Trials Clinical trials are a critical phase in the development of pharmaceutical products, ensuring safety and efficacy before market approval. Adhering to Good Manufacturing Practices (GMP) is essential in clinical…

GMP in Asia (PMDA, NMPA, KFDA)

FDA GMP Guidelines for Sterile Product Manufacturing

May 15, 2025 digi

FDA GMP Guidelines for Sterile Product Manufacturing Comprehensive Guide to FDA GMP Guidelines for Sterile Product Manufacturing Introduction to Sterile Product Manufacturing and FDA GMP Guidelines Sterile pharmaceutical products, including injectables, ophthalmics, and biologics, are critical to patient health and safety. Due to their direct introduction into the body, these products must be free from…

GMP in North America (FDA, Health Canada)

How Lean Manufacturing Can Improve GMP for Clinical Trial Supplies

May 15, 2025 digi

How Lean Manufacturing Can Improve GMP for Clinical Trial Supplies Improving GMP for Clinical Trial Supplies with Lean Manufacturing Introduction Clinical trial supplies are critical to the success of pharmaceutical research and development, ensuring that investigational drugs are delivered to trial sites in compliance with Good Manufacturing Practices (GMP). However, managing these supplies comes with…

Lean Manufacturing and GMP

How to Use Technology for GMP Compliance in Asian Pharmaceutical Manufacturing

May 15, 2025 digi

How to Use Technology for GMP Compliance in Asian Pharmaceutical Manufacturing Leveraging Technology for GMP Compliance in Asian Pharmaceutical Manufacturing Introduction to Technology in GMP Compliance The pharmaceutical industry is rapidly evolving, with technology playing a critical role in ensuring Good Manufacturing Practices (GMP) compliance. In Asia, regulatory authorities such as Japan’s Pharmaceuticals and Medical…

GMP in Asia (PMDA, NMPA, KFDA)

How to Ensure Compliance with FDA and Health Canada’s GMP for OTC Drugs

May 15, 2025 digi

How to Ensure Compliance with FDA and Health Canada’s GMP for OTC Drugs Practical Tips for Ensuring GMP Compliance for OTC Drugs under FDA and Health Canada Introduction to GMP Compliance for OTC Drugs Over-the-counter (OTC) drugs are widely available to consumers without a prescription, making their safety, quality, and efficacy critical for public health….

GMP in North America (FDA, Health Canada)

How PMDA’s GMP Guidelines Support Pharmaceutical Product Development in Japan

May 15, 2025 digi

How PMDA’s GMP Guidelines Support Pharmaceutical Product Development in Japan A Step-by-Step Guide to PMDA’s GMP Guidelines for Pharmaceutical Product Development in Japan Introduction to PMDA and GMP Guidelines The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan plays a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products. Its Good Manufacturing…

GMP in Asia (PMDA, NMPA, KFDA)

How to Achieve Lean GMP in the Production of Active Pharmaceutical Ingredients (APIs)

May 15, 2025 digi

How to Achieve Lean GMP in the Production of Active Pharmaceutical Ingredients (APIs) Achieving Lean GMP in API Production Introduction The production of Active Pharmaceutical Ingredients (APIs) is a critical component of pharmaceutical manufacturing, demanding strict adherence to Good Manufacturing Practices (GMP). API production involves complex processes, stringent regulatory oversight, and the need for precision…

Lean Manufacturing and GMP

The Role of Lean Manufacturing in Enhancing Supplier GMP Compliance

May 15, 2025 digi

The Role of Lean Manufacturing in Enhancing Supplier GMP Compliance How Lean Manufacturing Enhances Supplier GMP Compliance Introduction In the pharmaceutical industry, the quality and compliance of suppliers play a crucial role in maintaining Good Manufacturing Practices (GMP). Raw materials, components, and outsourced services must meet stringent GMP standards to ensure product safety, efficacy, and…

Lean Manufacturing and GMP

Best Practices for GMP Documentation in North America

May 15, 2025 digi

Best Practices for GMP Documentation in North America Comprehensive Best Practices for GMP Documentation in North America Introduction to GMP Documentation Documentation is a critical component of Good Manufacturing Practices (GMP), ensuring consistency, traceability, and compliance with regulatory requirements. In North America, both the Food and Drug Administration (FDA) and Health Canada emphasize the importance…

GMP in North America (FDA, Health Canada)

The Role of GMP in Regulatory Approval for Drugs in Asia

May 15, 2025 digi

The Role of GMP in Regulatory Approval for Drugs in Asia How GMP Compliance Supports Regulatory Approval for Drugs in Asia Introduction to GMP and Regulatory Approvals Good Manufacturing Practices (GMP) are the foundation of pharmaceutical quality, ensuring that drugs are consistently produced and controlled according to established standards. Regulatory authorities in Asia, such as…

GMP in Asia (PMDA, NMPA, KFDA)