Articles Microbiology Types of Sampling Methods in Environmental Monitoring 25 September 2024 gmpinsiders
Articles QC Expiry Dates for Commercial and In-House Prepared Reagents In QC Labs 20 August 2024 gmpinsiders Discover the best practices for establishing and managing expiry dates for commercial and in-house prepared reagents in QC labs.
News FDA Issues Warning Letter to LS Promotions Inc. for cGMP Violations 13 August 2024 gmpinsiders FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and steps for compliance.
Articles QA Different Types of GMP Documentation Used In Pharma Industry 5 August 2024 gmpinsiders Explore the different types of GMP documentation in the pharmaceutical industry, essential for maintaining quality, compliance, and safety in manufacturing processes.
News EDQM Publishes Revised Ph. Eur. Water Monographs for Feedback 25 July 2024 gmpinsiders EDQM releases updated Ph. Eur. water monographs, including key changes to Water for Injection, Purified Water, and TOC standards. Open for feedback until Sept 30, 2024.
Articles Manufacturing Primary vs Secondary Packaging in Pharma Industry 22 July 2024 gmpinsiders Explore the critical role of primary vs secondary packaging in the pharmaceutical industry, highlighting differences, protection, preservation, and regulatory compliance.
News FDA Issues Warning Letter to Chinese Medical Device Manufacturer for GMP Violations 19 July 2024 gmpinsiders FDA issues warning letter to Chinese medical device manufacturer for GMP violations, including CAPA failures, inadequate investigations, poor design validation, and labeling issues.
Articles Maintenance Manufacturing QA QC IQ, OQ and PQ: Importance in GMP 16 July 2024 gmpinsiders Discover the importance of IQ, OQ, and PQ in GMP, ensuring equipment and systems are installed and function correctly to maintain high-quality manufacturing standards.
Articles Maintenance Manufacturing QA QC Data Integrity and Data Governance in GMP 7 July 2024 gmpinsiders Ensuring data integrity and governance in GMP: a comprehensive guide to accurate, consistent, and reliable data management practices for pharmaceutical professionals.
News FDA Issues Warning Letter Due to cGMP Violations 2 July 2024 gmpinsiders FDA issues warning to for CGMP violations. Addressing insanitary conditions, quality control, lab testing, and component verification.
Articles GDP Cold Chain Management in the Pharmaceutical Industry 27 June 2024 gmpinsiders Discover the essentials of cold chain management in pharma to ensure the safety and efficacy of temperature-sensitive products like vaccines and biologics.