WHO Pharmaceutical products containing hazardous substances
Guideline on the handling of highly active material (drug product and API manufacutre). Focus on HVAC systems, also advice on personal proctective equipment (PPE)
WHO Technical supplements to Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products
Technischer Anhang zur WHO Guideline, mit u.a. Kapiteln zu Design und Wartung von Lagerhäusern, Feurschutz, Qualifizierung von Transportbehältern, etc.
PIC/S Questions & Answers DISTRIBUTION ACTIVITIES FOR APIs (PS INF 20 2011)
The document is intended to provide guidance to inspectors when inspecting areas relating to two topics: (a) Supply Chain & Distribution and (b) Repackaging & Relabelling operations
WHO Guidelines on transfer of technology in pharmaceutical manufacturing
This document gives guidance in principle and provides general recommendations on the activities necessary to conduct a successful intra- or intersite tranfer of technology (analytical transfer is also adressed). API and finished dosage forms are covered.
FDA Guidance for Industry: Non-Penicillin Beta-Lactam Drugs:
A CGMP Framework for Preventing Cross-Contamination
This guidance describes the importance of implementing appropriate steps during the manufacturing process to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam antibiotics.