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.
