Excipients are essential components of the medicinal product formulation. The quality of excipients is critical to ensure the safety, quality, and efficacy of medicinal products, because excipients provide a wide range of functionality.
Excipients can have multiple uses in medicinal products. Therefore, it is essential to apply principles of appropriate Good Manufacturing Practices (GMP) to excipients.
Users of excipients are increasingly required by regulatory authorities to ensure patient safety through the evaluation of risks and application of suitable GMP to the manufacture and supply of each excipient.
It should be recognized that once the excipient is in the supply chain, it may be subjected to further GMP related activities, such as re-packaging or re-labeling, before it reaches the final user. Such activities should be performed in compliance with GMP principles.
Pharmaceutical Excipients Guidelines
1. Guidelines on risk assessment for excipients GMP
Link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52015XC0321(02)&rid=6
2. Composition Guide for Pharmaceutical Excipients- IPEC
3. WHO Supplementary guideline for the manufacture of pharmaceutical excipients- Annex 5, WHO Technical Report Series 885
Link: https://www.who.int/publications/m/item/trs885-annex5
4. Eudralex Volumen 2C Guideline on Excipients in the labelling and package leaflet of medicinal products for human use
5. FDA Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients
Link: https://www.fda.gov/regulatory-information/......
6. WHO Good trade and distribution practices for pharmaceutical starting materials
Link: https://www.who.int/publications/m/item/annex-6-trs-996
7. Eudralex Volume 3 Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product CHMP/QWP/396951/06
Link: https://www.gmp-compliance.org/files/......
8. Eudralex Volume 3 VOLUME 3B Guidelines - Medicinal products for human use. Safety, environment and information: Excipients in the label and package leaflet of medicinal products for human use
Link: https://www.gmp-compliance.org/files/.....
9. The IPEC Excipient Information Package User Guide and Templates
Link:https://www.ipec-europe.org/uploads/publications/......
10. IPEC Excipient Stability Guide
Link: https://www.ipec-europe.org/uploads/publications/excipient-stability-guide/
11. The Joint IPEC-PQG Good Manufacturing Practices Guideline
Link: https://www.ipec-europe.org/.....
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