A Practical Guide to GMP, Quality Systems, and Inspection Readiness in the Pharmaceutical Industry — Based on Real Industry Experience
Omschrijving
The pharmaceutical industry is one of the most regulated environments in the world. GMP, Pharmaceutical Quality Systems (PQS), validation, inspection readiness, data integrity, and regulatory compliance are daily operational realities.
Inside the Pharmaceutical Industry is a practical guide based on real industry experience. It explains how GMP, Quality Systems, Process Validation, Cleaning Validation, Deviation Management, OOS, CAPA, Root Cause Analysis, Quality Risk Management, and Supplier Control function in practice.
This book goes beyond theory. It includes practical guidance on technical writing, inspection-ready documentation, quality training, On-the-Job Training (OJT), and building inspection readiness across departments.
You will understand not only what regulations require, but how they work during audits, inspections, and daily manufacturing operations. You will also gain insight into how medicines are developed and produced under GMP regulations and ISO standards to ensure product quality and patient safety.
Pharmaceutical quality is responsibility behind every batch.
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