Articles Maintenance Manufacturing QA QC User Requirement Specification: How to Create URS for Successful Equipment Procurement 20 December 2023 gmpinsiders Explore the essentials of User Requirement Specification (URS) for successful project execution. Learn to craft effective URS documents.
Articles GDP Maintenance Manufacturing Microbiology QA QC Regulatory Good Documentation Practice: Ensuring Data Integrity and Compliance in the Pharmaceutical Industry 14 December 2023 gmpinsiders Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability.
Articles Maintenance Microbiology QA GMP Cleanroom Classifications: Understand Class A, B, C and D 8 December 2023 gmpinsiders Learn GMP cleanroom classes A, B, C, D for contamination control in pharmaceuticals. Understand air cleanliness & particle counts for compliance.
Articles eQMS QA Electronic Quality Management Systems – eQMS 5 December 2023 gmpinsiders Optimize compliance and quality control in the pharmaceutical industry with eQMS (Electronic Quality Management System). Streamline documentation, enhance regulatory adherence, and elevate overall product quality.
News FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products 3 December 2023 gmpinsiders Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products. Stay informed on key considerations for eye care innovations.
Articles QA Regulatory GMP Regulatory Bodies: Understanding the Key Differences 1 December 2023 gmpinsiders Explore global GMP standards with regulatory bodies like FDA, EMA, and WHO. Ensure compliance for pharmaceutical quality and safety worldwide.
Articles Maintenance Manufacturing QA QC Qualification vs Validation: Key Differences and Importance in the Pharmaceutical Industry 23 November 2023 gmpinsiders Discover the difference between qualification and validation in regulated industries. Ensure compliance with GxP regulations for quality and safety.
Articles GDP QA QC Regulatory Understanding GxP Regulations in The Pharmaceutical Industry 18 November 2023 gmpinsiders Navigate success in the pharmaceutical industry with GxP compliance. Explore GMP, GLP, GDP, and GCP for quality, safety, and regulatory excellence
Articles Research & Development Performance Characteristics in Analytical Method Validation: Understanding the Significance 15 November 2023 gmpinsiders Learn how method validation performance characteristics align with GMP to ensure consistent industry-compliant results.
Articles Research & Development Analytical Method Validation: How It Affects Testing Integrity and Why Is It Important 12 November 2023 gmpinsiders An overview of analytical method validation and its critical impact on testing accuracy, reliability, and compliance with regulatory standards.
