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Correctly Implementing GMP and GDP Requirements
Current regulatory requirements and their implementation in practice
1st edition 2019
Delivery immediately after receipt of payment
Excerpt from the GMP Compliance Adviser
The quality of finished medicinal products and their starting materials must not be adversely affected during storage. This basic requirement of the GMP regulations constitutes a great challenge. Substance changes, contaminations and mix-ups are known and common risks.
This pharma guide explains the current regulatory requirements for storage of medicinal products and describes their implementation in practice. You will learn which requirements the premises must meet and how you can ensure the required storage conditions.
GMP-critical aspects in connection with material handling, warehouse organisation and goods receipt are also discussed. A detailed case study provides risk-based concepts for storage at room temperature and challenges conventional limits. The study investigates the question: What is the point of "heating" medicinal products to 15–25 °C?
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