Equipment quality in pharmaceutical manufacturing is ensured through IQ, OQ, and PQ phases, validating installation, performance, and user needs. Regulatory mandates prevent hazards, like mislabeling, with ongoing compliance via requalification. Expert guidance streamlines validation efforts for robust, compliant systems.
GAMP is the acronym used to summarize the term “Good Automated Manufacturing Practices“. These are a compilation of recommendations published by the International Society for Pharmaceutical Engineering (ISPE) in the form of a book to provide guidance on the compliance of computerized systems in regulated industries.
In the pharmaceutical industry, GMP inspections ensure quality and compliance, demonstrating commitment to safety and building trust with healthcare professionals and patients. Understanding the inspection process, guidelines, and common deficiencies is crucial for upholding industry standards and ensuring patient safety.
Is continuous improvement essential for pharmaceutical companies? Dive into methodologies like Lean, Six Sigma, and Kaizen for measurable results
Is your pharma company still relying on periodic CSV checks? Uncover how AI can elevate your validation processes, reduce risks, and give you a competitive edge in the market.
Find out why you should consider Quality Management and how we can support you on this journey
The challenge of efficient Computer System Validation (CSV) is one that many organizations face. But what if you could master CSV without the usual headaches?
In an interview with Pharmatechnik magazine, Alireza Zarei discussed the challenges of digital compliance in the pharmaceutical industry
From research to reality: TerraTrust, the green pregnancy test.
