InstantGMP Compliance Series - Supplier and Vendor Qualification
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There are specific requirements in the GMPs for qualifying suppliers and vendors. This presentation describes how to go about going this.
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InstantGMP Compliance Series - Supplier and Vendor Qualification
- 1. InstantGMP Compliance Series for cGMP Dietary Supplements Supplier and Vendor Qualification
- 2. Problems - Qualifying Vendors • FDA issued Warning Letters for GMP violations of Dietary Supplement Health and Education Act • Failure to adequately identify incoming dietary ingredients • Not establishing reliability of suppliers COA • Not validating testing done by supplier Electronic cGMP Manufacturing Execution System
- 3. Why Qualifying Vendors is Important • Essential to show materials come from approved vendors • Reduces amount of final product testing needed during or after production • Reduces risk of final product being contaminated or adulterated Electronic cGMP Manufacturing Execution System
- 4. How to Improve • Establish a Vendor Verification program • Program should include: – Audits of suppliers and vendors – Confirming the test results of certificates of analysis – Re-qualifying the vendor at periodic intervals • Check that COAs include specifications for identity, description, limits on contaminants, results, strength, and tolerances Electronic cGMP Manufacturing Execution System
- 5. DSHEA Requirements • Conduct at least one test to verify identify of each in-coming dietary ingredient • COAs for other components are OK if: – Test results are confirmed – COA contains test, methods, acceptance limits and results – There is documentation on how supplier was qualified – Periodic requalification is conducted – Quality reviews and approves supplier Electronic cGMP Manufacturing Execution System
- 6. Quality Surveys and Audits • GMP Quality Survey – Used to pre-qualify a vendor before deciding on a more formal audit – An example can be found at www.instantgmp.com/Quality-Assurance-Templates • On-Site Audit – Conducted by a Quality professional – Defines the authorized services or product Electronic cGMP Manufacturing Execution System
- 7. Vendor Verification Program • Qualification of all suppliers including components, ingredients and labels • Periodic audits and re-qualifying of vendors • Confirmation of vendor's test results and COAs • Reviews of specifications, procedures, and lab controls • Regular review of vendor’s documentation Electronic cGMP Manufacturing Execution System
- 8. Audit Plan • Agenda – list of areas and items to be reviewed • Documents Requested prior to Audit • Organizational structure • Facility inspection • Quality systems review • Documentation Control and Record Keeping • Training/ Personnel Electronic cGMP Manufacturing Execution System
- 9. Audit Plan - Manufacturing • Calibration procedures and documentation • Procurement and Materials • Processing and In-process inspection • Final inspection and testing • Distribution • QC Laboratory • Example at www.instantgmp.com/Quality- Assurance-Templates. Electronic cGMP Manufacturing Execution System
- 10. InstantGMP™ Find more videos on GMP Manufacturing in the Resource Center at www.instantgmp.com
Editor's Notes
- The staff at InstantGMP prepared the GMP for Dietary Supplements Compliance Series of presentations to focus on good manufacturing practices and GMP compliance for dietary supplements manufacturing. These are brought to you by our quality and manufacturing experts in the hope that it will help you avoid any GMP compliance issues in your shop. This presentation will address the qualification of suppliers and vendors.
- The FDA issued Warning Letters for GMP violations of Dietary Supplement Health and Education Act that with citations concerning supplier and vendor qualification and certification. They issued one to a dietary supplement manufacture when found the firm had failed to provide sufficient assurance that products received from a supplier were adequately identified and consistent with their purchase order. Another firm failed to qualify suppliers of components other than dietary ingredients. They did not establish the reliability of the suppliers’ COA through confirmation of the results of the suppliers’ tests or examinations. A third firm did not establish the reliability of the supplier’s COA for raw materials tests such as pH, Water-soluble substances, Residue on Ignition and Assay.
- An effective vendor qualification program is essential to ensure that material and components are procured from and provided by vendors that have been approved by a Quality Assurance representative. A well functioning vendor qualification program can significantly reduce the amount of testing that has to be done on in-coming materials. It also reduces the risk of a final product become contaminated or adulterated. The FDA is conducting ever more inspections of dietary supplement manufacturers and packagers and they are expecting a higher compliance rate in the future.
- The first step is to establish a Vendor Verification program. This program should include: 1) Audits of suppliers and vendors, 2) Confirming the test results of certificates of analysis and 3) Re-qualifying the vendor at periodic intervals Check that COAs from vendors include specifications for identity, description, limits on contaminants, results, strength, and tolerances.
- The Final Rule of the Dietary Supplement Health and Education Act requires that a manufacture of dietary supplements conducts at least one appropriate test or examination to verify the identity of each dietary ingredient that will be used in the manufacture of the dietary supplement. A firm may use certificates of analysis from supplier of a components (but not dietary ingredients), if certain criteria are met : (1) The firm first qualifies the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations; (2) the certificate of analysis includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (3) the firm maintains documentation of how it qualified the supplier; (4) the firm periodically reconfirms the supplier's certificate of analysis; and (5) the firm's quality control personnel review and approve the documentation setting forth the basis for qualification (and requalification) of any supplier.
- A GMP Quality Survey can be used to pre-qualify a potential vendor before conducting a more formal audit. An example can be found in the InstantGMP Resource Center at http://www.instantgmp.com/Quality-Assurance-Templates. The quality assessment, whether a survey or on-site audit must be conducted by a Quality professional. The assessment must define the service or product the vendor is authorized to supply. The assessment must be approved by a Quality representative.
- A Vendor Verification Program should consist of: Qualification of all suppliers including components, ingredients, labels, etc. audits and periodic re-qualification of vendors, Confirmation of vendor's test results and certificates of analysis Reviews of specifications, procedures, and lab controls Regular review of vendor’s documentation
- A typical audit plan for a qualifying a dietary ingredient vendor or other component supplier will include the following: Agenda – make a list items you expect to review during the audit - for example, Current Organizational Charts, previous FDA/Regulatory Inspections, EIRs, FDA-483’s, Warning Letters etc. Documents Requested prior to Audit - List any documents you would like the audit site to send prior to the audit. Organizational structure - clearly define the line of authority and responsibility for quality. Facilities – inspect all areas of the facility to determine if they are well designed, organized and clean. Equipment must be maintained and environmental controls employed. Quality Systems - records of all inspections, evaluations and validations performed should be analyzed. Documentation Control and Record Keeping - evaluate how control of documentation is done. Training/ Personnel - assess adherence to corporate policies and GMPs regarding cleanliness, garments and personal habits.
- The audit plan for assessing manufacturing will include an inspection of: Calibration procedures and documentation – check for Periodic inspection and calibration of tools, gages, testers, and equipment. Procurement and Materials – assure suppliers have been monitored and incoming materials requirements have been met Processing and In-process inspections – assure that quality characteristics have been evaluated and verified during the production process. Final inspection and testing – determine that these ensure the acceptability of the product. Evaluate if rejections have been investigated thoroughly and corrective actions implemented. Distribution – determine that traceability of the material/product was maintained throughout the distribution chain. QC Laboratory – Check the lab areas for acceptability and procedures for adequate validation and review. An example of an Audit Checklist can be found in the InstantGMP Resource Center at http://www.instantgmp.com/Quality-Assurance-Templates.
- Thank you for viewing our series on GMPs. You can find more videos and articles on GMP manufacturing in our Resource Center at www.InstantGMP.com.