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To provide written instructions for qualifying, disqualifying, and requalifying suppliers of finished product dietary supplements, in order to determine if suppliers meet our expectations.
Quality Control or Operations Management is responsible for qualifying, disqualifying, and re-qualifying suppliers of finished product dietary supplements.
QC will draft and send the Supplier Qualification Questionnaire to the potential supplier, requesting it be returned for evaluation as soon as possible. Summary Of QuestionsDoes your facility have a Food Facility Registration number? Expiration date: Please provide the address of the FDA-registered facility. Has your facility been inspected by the FDA or any other government agencies? If yes, which ones? Has your facility ever received a FDA Form 483 or a Warning Letter following an inspection?Has your facility ever had to conduct a recall?Please list all current DBAs (other business names), former DBAs, and parent companies for your facility: Please list all dosage forms produced without outsourcing in your facility (e.g., capsules, tablets, powders, etc.): How many full-time employees work at your facility? How many employees are part of quality control personnel? Will you please attach your current organization chart?Do you follow written procedures for quality control operations?Do you have training documentation of employees that includes date and training types?Do you follow written procedures cleaning your facility and maintaining the physical plant and grounds?Do you have a service contract with a pest control company?Do you follow written procedures for equipment and utensils?Do you follow written procedures instrument calibrations?Do you follow written procedures for cleaning and sanitizing equipment and utensils?Do you follow written procedures for controlling temperature and humidity in your facility?Do you create written specifications for components, in-process materials, labels, packaging components, and finished products?Do quality control personnel ensure all specifications for components, in-process materials, labels, packaging components, and finished products prior to releasing the finished products for distribution?Do you collect reserve samples for all finished products, and hold them in the same container closure system in which the packaged and labeled dietary supplement are distributed?Do you create master manufacturing records for each product and unique batch size you make?
Please attach an example master manufacturing record (please redact any proprietary or confidential information). Will you provide copies all master manufacturing records associated with our manufactured products at any time upon request?Do you create batch production records for each product you make? Please attach an example batch production record (please redact any proprietary or confidential information).Will you provide copies all batch production records associated with our manufactured products at any time upon request?Do you follow written procedures for product complaints?Do you follow written procedures for investigations related to product complaints, out of specification results, etc.?Do you follow written procedures for manufacturing operations?Do you take appropriate precautions to prevent against contamination of components or dietary supplements? Do you clearly identify, hold, and control under a quarantine system all incoming components, products awaiting disposition decisions by quality? Do you follow written procedures for packaging and labeling operations?Do you follow written procedures for holding and distribution operations?Do you maintain distribution records?Do your quality control personnel qualify the contract laboratories that you use? Which contract laboratories do you currently use for analytical testing? Which set(s) of FDA cGMP regulations does your facility comply with (e.g., 21 CFR 111, 110, 117, 210, etc.)? Do you have a table of contents for your standard operating procedures? If yes, please attach. Upon receiving the completed F-007 – Supplier Qualification Questionnaire from the supplier, QC will evaluate and fill out F-004 – Supplier Qualification. Per form F-004 – Supplier Qualification, QC will also perform an online search for any past or pending FDA, legal, regulatory, or other issues that might be concerning. Any missing or additional information needed for evaluation will be requested. If the supplier is qualified, it is recorded in the , and purchase orders may be made. If the supplier is disqualified, it is recorded in the , and purchase orders may not be made unless:Corrective actions are made by the supplier to gain qualification.
Supplier requalification should be done approximately every three years. QC will notify the supplier of the need for requalification and send the F-007 – Supplier Qualification Questionnaire, requesting it be returned for evaluation as soon as possible. Upon receiving the completed F-007 – Supplier Qualification Questionnaire from the supplier, QC will evaluate and fill out F-004 – Supplier Qualification.Per form F-004 – Supplier Qualification, QC will also perform an online search for any past or pending FDA, legal, regulatory, or other issues that might be concerning. Any missing or additional information needed for evaluation will be requested. If the supplier is requalified, it is recorded in the Supplier Qualification Log, and purchase orders may be made. If the supplier is disqualified, it is recorded in the Supplier Qualification Log, and purchase orders may not be made unless:Corrective actions are made by the supplier to gain requalification. All supplier qualification documentation will be stored in the folder for Contract Manufacturers. On-site audits may also be used as an alternative and preferred method of supplier qualification.
PURPOSE
RESPONSIBILITY
REFERENCES
F-004 - Supplier Qualification.docx
16.1 KB
F-007 - Supplier Qualification Questionnaire.docx
23.3 KB
PROCEDURES
New supplier qualification
Supplier requalification
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