Recommendations for an Effective Vendor Qualification Program - Part 1 of 2

Written by Teresa Jaworski - Subject Matter Expert, QPharma

According to a June 16, 2010 article posted on the International Pharmaceutical Quality (IPQ) website, FDA Fast-Tracking Supply Chain cGMP Upgrades; Other GMP Changes, Quality Agreement Guidance Taking Shape, “FDA is fast-tracking a set of changes to 21 CFR Part 211 targeting control of raw materials, excipients and components used in pharmaceutical manufacturing.”

The Center for Drug Evaluation and Research (CDER) Office of Compliance Team Leader Brian Hasselbalch announced these impending GMP proposals at a Global Outsourcing Conference at Xavier University on June 14, emphasizing that “adulteration issues represent credible threats to our marketplace and that raw material controls have to be improved.”

Hasselbalch further explained “They will require drug producers to know who the original manufacturer is for all excipients and active ingredients, and any subsequent repackers and relabelers – that you know who they are, who handles [the material] in the supply chain, similarly to the EMA proposed pedigree.”

As discussed earlier in a September 2010 blog, the U.S. Food and Drug Administration (FDA) Guidance for Industry Q10 Pharmaceutical Quality System, which is in accordance with 21 CFR Part 820.50, specifies that Pharmaceutical companies are ultimately responsible for ensuring that processes are in place to assure the control of outsourced activities and quality.  We are now going to dig a little deeper to discuss how these controls can be accomplished.

A company should establish and implement processes that can determine the suitability and competence of a vendor for their specific needs.  These processes should include establishing approved procedures; performing audits; ensuring the vendor is qualified prior to selecting them as a vendor; and continuing to monitor the vendor’s performance after qualification including re-qualifying the vendor at established time intervals.

Establishing Approved Procedures

When establishing approved vendor qualification procedures, keep in mind that the procedures should include, at minimum, guidelines for the following:

• selecting a potential vendor for the products or services needed
• defining and documenting requirements and specifications to be met by the vendor
• determining whether the vendor is a critical or non-critical vendor
• auditing requirements for both a critical and non-critical vendor
• distributing the pre-audit questionnaire for completion by the potential vendor
• determining the vendor suitability as a result of the completed pre-audit questionnaire
• planning, scheduling and conducting on-site vendor audits
• preparing audit reports
• following up on any audit findings to ensure appropriate CAPAs have been implemented
• defining time intervals for re-qualifying/re-auditing vendor
• completing and maintaining vendor Quality Agreements
• developing and maintaining an Approved Vendor List
• storing all required vendor qualification documentation including pre-audit questionnaires, audit checklists and notes, audit reports, Quality Agreements, Approved Vendor List, etc.
• handling vendor relationships when requirements are no longer being met

It is also recommended that the following templates be included, or their location referenced, in the vendor qualification procedures to ensure consistency and to ensure that requirements are being met:

• Pre-audit Questionnaire, which should comprise requests for relevant information  such as the following:
• company name
• company location
• contact information (telephone, fax, email)
• company history
• product(s) or service(s) provided
• number of employees
• details of implemented quality systems
• dates of last regulatory audits (FDA, ISO, etc.)
• Audit Checklist for auditing critical vendors
• Audit Checklist for auditing non-critical vendors
• Audit Report
• Quality Agreement
• Approved Vendor List

Training should be conducted and documented on the approved procedures prior to being used, emphasizing the need for quality support during all phases of the vendor qualification process.

Stay tuned for Part 2, coming next Monday, November 15th!