The pharmaceutical Quality Unit has been the target of many FDA Warning Letters as the underlying cause of product quality and CGMP compliance problems. We have seen instances where the ultimate “no confidence” vote is cast when third-party experts are either recommended by FDA, or court ordered to take over their duties. (See The QA Pharm 9/25/10.)

Therefore, it’s very important to have a clear understanding of the regulatory responsibilities of the Quality Unit and to ensure that those responsibilities are effectively executed.

Remember—the Quality Unit is the only job description that appears in the Code of Federal Regulations!

Here’s my compiled list from FDA regulations and guidance documents that defines the job of the Quality Unit.

(It’s like being given the answers in the back of the book—and not just the odd-numbered problems.)

1.    To establish the quality system

  • Establish the quality management system to describe how the firm follows CGMPs and operates to maintain a state of control
  • Keep the quality management system current with good industry practices

2.    To audit compliance to the quality system

  • Audit for compliance to policies and procedures: on paper vs. practice.
  • Report quality system performance metrics, including trends, that help decision-making and taking proactive targeted actions

3.    To establish procedures and specifications

  • Ensure that procedures and specifications are appropriate and followed
  • Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.)

4.    To establish manufacturing controls

  • Ensure that appropriate manufacturing in-process controls are implemented
  • Ensure in-process controls are performed during manufacturing operations and results are satisfactory

5.    To perform laboratory tests or examinations

  • Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications
  • Approve or reject drug products manufactured, processed, packed, or held under contract by another company, i.e., final product release is not delegated to a contractor.
  • Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions

6.    To review and approve or reject all things CGMP

  • Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents
  • Review and approve/reject reprocessing and rework procedures
  • Review and approve/reject production batch records and make the final decision to release a product lot into commerce.

7.    To ensure investigation of nonconformance

  • Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes
  • Review complaints to determine if it relates to a failure to meet specification, if so investigate and report to FDA if it is serious and unexpected

8.    To keep management informed

  • Report on product, process and system risks—and keep management informed
  • Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure—and keep management informed.
  • Keep management informed—get it?

9.    To describe responsibilities in writing

  • Have a complete and compliant procedure that describes responsibilities
  • Follow the procedure

10. To remain independent

  • Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities
  • Be independent reviewer and approver with respect to manufacturing and process/ product development units
  • Don’t drink the “Kool-Aid”

Your assignment:

Conduct a facilitated off-site meeting comprised of members of your Quality Unit Staff and other operating areas. Walk through this list and ask: “How does our Quality Unit stand up to these requirements?” Develop an action plan.

republished and adapted with permission from The QA Pharm


•    Federal Register Vol. 43, No 190 – Friday, September 29, 1978, “Preamble to the Drug CGMPs”
•    The Code of Federal Regulations Part 210 and 211
•    Guidance for Industry, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (September 2006)