InstantGMP Compliance Seriesfor cGMP Dietary Supplements

Supplier and Vendor Qualification

Electronic cGMP Manufacturing Execution System

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

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

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

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

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

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

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

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.

InstantGMP™

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