Terms & Definitions
Common terms you may find helpful when using our website or communicating with colleagues:
Industry Expert – A paid professional working in the industry for an extended period of time, generally more than 15 years. This person has demonstrated skill and mastery over a given subject matter and has handson experience in the field. Demonstrated skill and ability that stands out from among their peers.
CMO – Contract Manufacturing Operation. This generally refers to a third party that has been contracted to perform manufacturing or packaging operations on behalf of a manufacturer. This may also be called a CSP, Contract Service Provider. Generally, a CMO is a manufacturer while a CSP is more general and can be a manufacturer, warehouse, testing facility, laboratory, etc.
CSP – Contract Service Provider. See definition above for CMO.
Approved Vendor – An approved vendor is someone who has gone through your company’s vendor qualification program. Once the vendor has been qualified they are generally:
- placed on an approved supplier list (ASL)
- routinely tracked and monitored
- their quality and performance metrics are reviewed annually
ASL – Approved Supplier List. This document is generally managed by Quality Assurance, Purchasing, or Supplier Controls. The document is revision controlled and maintained as a quality record. This document should be controlled within the Quality System. Vendors (or Suppliers) shall be added or removed from the list based on their ability to meet the customer’s requirements and quality standards. The vendor status and what they are approved for should be clearly indicated.
Vendor Audits – Vendor audits are generally conducted to
- qualify a new vendor,
- conduct a periodic re-qualification or monitoring of already qualified vendors
- address a quality Issue or a series of non-conforming events (a For Cause Audit)
As clients move from non-GMP to GMP activities they need to consider which vendors will be used for GMP manufacturing and testing. Vendors should be risk assessed and critical vendors should be audited. Audits generally check conformance of the vendor’s quality system, the ability to meet customer requirements, and the ability to meet FDA (or other) regulations.
For Cause Audit – An audit initiated due to a quality concern or know quality issue. Both FDA and industry perform “For Cause Audits” as needed. For cause audit generally have little notice and are driven by a specific quality concern. For Cause Audits should use subject-matter experts and quality professionals to objectively review the potential quality issue. Detailed records and a final audit report should be kept. This should not be an informal exercise.