The manufacturing operations of Amazon Filters’ customers from the Pharmaceutical Industry are controlled by country or regional based independent Regulators such as FDA and EMA. Information on two of these can be seen below and these are typical of most of the Regulators found across the world.
US Food and Drug Administration
FDA is responsible for protecting the public health of the USA by assuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.
This is achieved by approval of these products and inspection of facilities that manufacture these products. Facilities inspected include :-
- Vaccine and drug manufacturers
- Compounding pharmacies
- Facilities that conduct studies in people (clinical trials)
- Laboratories that conduct studies in animals or microorganisms when these studies are used to apply for FDA approval of a medical product
- Distributors of drug products
- Foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States
Their remit does not extend to suppliers to these industries (except API suppliers). FDA does not have the resources to inspect and approve suppliers even if they were invited by the suppliers to do so. The only reason for FDA to inspect a filter manufacturer would be if the company manufacturers filters that are medical devices e.g. intravenous fluid delivery filters or breathing circuit filters.
European Medicines Agency
The remit of the European equivalent to FDA is very similar although the structure is somewhat different. EMA is only responsible for medicines so has no responsibility for food safety. It also has a coordinating responsibility with the individual country based Medicines Inspectorates e.g. MHRA in UK, carrying out the approvals and inspections.
Similarly to FDA the MHRA will inspect both UK and overseas drug product and medical device manufacturers and distributors, but not their suppliers unless the material is an API. They do not have the resources to do this and it is outside their scope of responsibility. Like FDA, a European Medical Agency may inspect a filter company only if it manufactures a filter that is classified as a medical device, but only the part of the manufacturing operation that relates to the medical device.
Amazon Filters’ Manufacturing Facility and Quality Management Systems
Amazon Filters Ltd is fully conversant with the Quality Standards expected by its customers and how these are influenced by the organisations that regulate their operations.
All our products are fully traceable and validated. For filters typically used in the pharmaceutical industry the following additional steps are taken :
- The end of the each filter cartridge is marked with a part code, identifying the cartridge type, module batch and serial number.
- The inner and outer packaging labels are printed (in alpha-numeric and barcode form) with the filter part number, batch number and manufacturing date.
- These identifying numbers allow full product traceability back to manufacturing processes and raw material lot numbers.
- Supported by comprehensive Product Validation Guides providing detailed information on performance testing, materials of constructions and Quality Standards.
In addition, our facilities and processes have been regularly audited and have been shown to be in compliance with current GMP requirements for suppliers of disposable product contact items to the pharmaceutical and food industries as laid down by the US Food and Drugs Administration (FDA) (specifically with the relevant parts within 21CFR), the European Medicines Agency (EMA) and the Food Regulations relating to the European Community.
Meeting these standards is assured by the operation of third party accredited Quality Management Systems that are compliant with the requirements of ISO9001:2008 and confirmation of this is provided on the Certificate of Conformance supplied with each delivery of filters.
More details on Amazon Filters’ operations and products are freely available at our website www.amazonfilters.com.