News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts. WEEKLY
How to Develop a Practical (and Compliant) Vendor Qualification Program
This article introduces the "Q.U.E.S.T." approach for vendor qualification, a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well-informed purchasing-related decisions.
E = Evaluation Phase: Identification of the best potential vendor
Now that at least three vendors have been identified to meet the company's requirements, it is time for vendor evaluation.
First, each vendor is assessed against the company requirements as specified in the Question Phase. All of the potential vendors
previously identified will be able to meet each and every requirement specified—vendors that could not meet the requirements
have already been eliminated. This evaluation pertains to how well each vendor meets each requirement when compared to the
other short-listed vendors. The format of this evaluation can be as simple as a table with columns for the vendor and for
the requirements where a simple rating system is applied to each requirement for each vendor.
Table I: Example API vendor evaluation.
An example of such a table for the evaluation of an active pharmaceutical ingredient (API) supplier is shown in Table I. Once
the ratings are assigned, a simple average can be used to determine the best overall option. Keep in mind that this is not
the final step in the process. The Evaluation Phase has only identified and documented the best potential vendor.
S = Site Audit Phase: Onsite and offsite verifications
Table II: Example vendor type criticality assignment.
The next-to-last phase in the vendor qualification process involves a site audit of the potential vendor's facility. As the
cost of an audit is a potentially pricey activity, the site audit maybe performed onsite or offsite depending on the criticality
of the potential vendor type and is limited to the best potential vendor identified in the Evaluation Phase. Vendor types
need to be divided into critical and noncritical suppliers. A critical vendor is one that supplies goods or services that
directly controls or dictates the quality and integrity of pharmaceutical and biopharmaceutical products. A noncritical vendor
is one that supplies goods or services that assist and support the quality of these products. As the interpretation of the
definitions of critical and noncritical suppliers varies among companies, it is imperative that an approved and controlled
company document (or documents) clearly defines which vendor types are deemed critical and which are deemed as non-critical.
Examples of critical and noncritical vendor types are listed in Table III.
Table III: Example onsite verification form – contract packaging facility.
If the best potential vendor identified in the Evaluation Phase is a potential critical vendor, it is highly recommended that
this vendor be subjected to an onsite audit with predetermined (i.e., documented and approved) items requiring onsite verification.
The onsite audit procedure should contain clear pass/fail criteria for the onsite vendor audit. An example portion of a form
to be completed during the onsite verification for a contract packager is shown in Table III.
Table IV: Example offsite audit checklist – calibration contractor.
If the best potential vendor identified in the Evaluation Phase is a potential noncritical vendor, the vendor should be subjected
to an offsite audit with a separate predetermined (i.e. documented and approved) audit checklist containing predetermined
pass/fail criteria for the overall audit. While the verifications maybe similar to that of an onsite audit, the offsite audit
relies on verbal discussions, emails, and documentation provided by the potential vendor to determine acceptability of the
vendor's practices and quality systems. An example portion of a checklist for an offsite audit for a calibration contractor
is shown in Table IV.
Based upon the overall score for both onsite and offsite audits, a potential vendor is either accepted or rejected. If accepted,
the vendor is considered qualified. If rejected, the company can either work with the vendor to address the deficiencies and
perform a verification audit at a later date (but prior to using the vendor or considering the vendor qualified), or select
another potential vendor identified during the Evaluation Phase and subject that vendor to the Site Audit Phase.
Nancy Cafmeyer is a consultant at Advanced Biomedical Consulting (ABC), LLC, with over 28 years industry experience has consulted at numerous pharmaceutical, nutritional supplement, and medical device manufacturers and prior to working for ABC has held both hand-on and management positions at companies such as King Pharmaceutical, Geopharma, and Daniels Pharmaceuticals. Advanced Biomedical Consulting (ABC), LLC, PO Box 76405, St. Petersburg, FL 33734, tel. 888.671.4292, fax 727.897.9522.
Articles by Nancy Cafmeyer
Jonathan M. Lewis, a principal at Advanced Biomedical Consulting (ABC), LLC, has consulted at over 50 different biopharmaceutical, pharmaceutical, and medical device manufacturers and prior to starting ABC has held both hand-on and management positions at companies such as Cardinal Health, KMI, and PAREXEL International. Advanced Biomedical Consulting (ABC), LLC, PO Box 76405, St. Petersburg, FL 33734, tel. 888.671.4292, fax 727.897.9522
Articles by Jonathan M. Lewis
Survey
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
20%
To all process for new products only
13%
To select process for new products only
24%
To select processes for both new and legacy products
