Industry Overview
Industry Overview
GLOBAL REGULATORY AUTHORITHIES
We work with globally recognized regulatory agencies in various parts of the world to ensure that all our products meet required stipulated regulatory standards. These agencies includes:
- FDA (US, China, India)
- EMA / MHRA / FAMHP
- Health Canada
- Swiss Medic
- ANSM
- PDMA
REGULATORY COMPLIANCE
The recent heparin contamination investigations have cast a spotlight on suppliers to the Pharmaceutical industry. As a result, the FDA is increasingly vigilant in inspecting overseas manufacturing facilities and in enforcing the manufacturers’ responsibilities to ensure their supplier’s compliance.
Under the CGMP at CFR Part 211.84, the regulation permits a manufacturer to release a shipment of raw material and/or packaging material based on the supplier’s certificate of analysis and a visual identification of the material or component.
The reliability of a supplier needs to be established through appropriate validation of the supplier’s test results at appropriate intervals. An established supplier qualification program would provide adequate evidence that the supplier can consistently provide reliable and safe materials. Suppliers should be monitored and regularly scrutinized to assure ongoing reliability. It is the manufacturer’s responsibility to ensure that their suppliers are suitable and qualified.
The reliability of a supplier needs to be established through appropriate validation of the supplier’s test results at appropriate intervals. An established supplier qualification program would provide adequate evidence that the supplier can consistently provide reliable and safe materials. Suppliers should be monitored and regularly scrutinized to assure ongoing reliability. It is the manufacturer’s responsibility to ensure that their suppliers are suitable and qualified.
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