Frequently Asked Questions
- Do you have an established QMS? YES. We are ISO certified. Standard: SI ISO 9001:2015. We were certified to ISO13485 from 2010 to July 2022. Due to that ISO13485 cover only manufacturing of medical devices and not biochemicals, therefore it is not applicable to Fermentek's class of activities.
- Is your facility registered by FDA? NO
- Do you have a Quality Manual? YES
- Do you certify your vendors, suppliers, sub-contractors? YES. Our raw materials suppliers must be ISO certified. We perform an audit at our subcontractors manufacturing site, and supervise their manufacturing operations
- Do you supply Certificate of Analysis? YES. COA is included in all shipments.
- Do you supply Certificate of Origin? Not routinely. Certificate of Origin is given to any customer who asks for. Certificate of Origin is backed by the certificates of origin of all animal-derived raw materials relevant to the product in question.
- If you supply products that contain animal material, can you provide information regarding the source, location, facility registration numbers and animal health? NO. In no case do we manufacture materials from animal source, though we use animal derived raw materials in some manufacturing procedures. In such cases, we only can present the documentation obtained from the vendors.
- Do you have a Change Control system? YES. In the case of GMP/API products, all changes introduced into the manufacturing procedure, raw materials, and analytical methods and specifications, are registered in the Product File, along with the reference to the corresponding product development documentation. A new version of the Master Product Record is then issued.
- Do you provide change notifications to customers? YES, only in cases of contract manufacturing of GMP/API products, and only if that had been agreed upon.
- Do you have a quarantine system for nonconforming product? YES
1. Finished goods storage is physically separated from the manufacturing.
2. No product may be stored in the "finished goods storage" unless all tests are successfully finished and it is finally approved and CoA is issued.
3. No product can be shipped without a final, approved CoA.
4. Nonconforming product is either immediately disposed of, or reworked, and does not leave the manufacturing area
- Do you have "Out of Specs" investigation procedure? YES
- Do you have a procedure for conducting recalls? YES
- Do you have a customer complaint handling system? YES
- Do you have a documented contingency plan established in the event of an emergency or a natural disaster? YES
- Do you have an employee training program? YES
- Do you have approved manufacturing instructions? YES
- Do you have controlled records of manufacturing procedures? YES
- Do you review your manufacturing and resting records prior to product release? YES
- Do you test your products to established specifications? YES
- Do you have stability data? Yes, for products manufactured under GMP regime.
- Do you have documented procedures for equipment / facility cleaning? YES
- Do you have an equipment calibration program? YES