Saturday, August 6, 2011

TheTop Ten Responsibilities of the Pharmaceutical Quality Unit

The pharmaceutical Quality Unit has been the target of many FDA Warning Letters for not establishing an effective system to prevent 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

a.  Establish the quality management system to describe how the firm complies
CGMPs and operates to maintain a state of control

b.  Keep current with good industry practices, and applicable to the mission of your operation.

2.    To audit compliance to the quality system

a.  Audit for compliance to policies and procedures: on paper vs. practice

b.  Report on the performance of the quality system, including trends, that help
decision making for targeted actions

3.    To establish procedures and specifications

a.  Ensure that procedures and specifications are appropriate and followed

b.  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

a.  Ensure that appropriate manufacturing in-process controls are implemented

b.  Ensure in-process controls are performed during manufacturing operations and results are satisfactory

5.    To perform laboratory tests or examinations

a.   Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications

b.  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

c.  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

a.  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

b.  Review and approve/reject reprocessing and rework procedures

c.  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

a.  Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes

b.  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

a.  Report on product, process and system risks—and keep management informed

b.  Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure—and keep management informed

c.  Keep management informed—get it?

9.    To describe responsibilities in writing

a.  Have a complete and compliant procedure that describes responsibilities

b. Follow the procedure

10. To remain independent

a.  Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities

b.  Be independent reviewer and approver with respect to manufacturing and process/ product development units

How does your Quality Unit compare?
Please contact me to discuss how we can work with your senior staff and quality leadership to ensure your Quality Unit has robust processes to fulfill its regulatory responsibility, as well as help you to become an anticipating organization--rather than reactive.

John Snyder
The QA Pharm

The QA Pharm is a service of John Snyder & Company, Inc.

John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.

Contact us at


  • 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)
  • ICH Q10 Pharmaceutical Quality System (June 2008)


  1. wonderful information, I had come to know about your blog from my friend nandu , hyderabad,i have read atleast 7 posts of yours by now, and let me tell you, your website gives the best and the most interesting information. This is just the kind of information that i had been looking for, i'm already your rss reader now and i would regularly watch out for the new posts, once again hats off to you! Thanks a ton once again, Regards, QA online trainingamong the QA in Hyderabad. Classroom Training in Hyderabad India

    1. Thank you. Please keep checking back. Let me know how you use the information in your situation.

      The QA Pharm

  2. I am always pleased to hear that that my blogs are useful. Thank you.

    The QA Pharm

  3. Thank you, IPQA. Tell me more about yourself

    The QA Pharm

  4. very good informations

  5. Thank you, Kathiravan. If you have any questions, you can email me personally at

    The QA Pharm

  6. i want to kno about handling of deviations and handling of market complaint

    1. Hello Pooja.

      Are asking whether QA has a role with the Deviation and Complaint Handling systems?

      Yes, they definitely do have the role of reviewing and approving associated investigations. However, QA should not "own" the deviation or complaint. They do need to ensure the adequacy of the investigation.

      If QA were responsible for both conducting the investigation and reviewing/ approving the investigation, it would be a conflict of interest---QA would be reviewing its own work. The Deviation Owner should be a responsible person in the area where the deviation occurred, or the quality system owner associated with the failure.

      Thanks for your comment.

      John Snyder
      The QA Pharm

  7. How we can handle the nonconformances, IQA, IPQA and how can i prepare cleaning validation report? Pls reply me

    1. Gangadhar, thank you for your question. Please email me with more details. Thanks.

  8. very useful blog for QA Proffessionals.

  9. Thank you QA pharma for very usefull informtion. Very much helpfull it is.

  10. very useful information thank u

  11. should the control sample room be under qc or qa?

    1. In my opinion, Quality Assurance (QA) would ensure that procedures are in place and followed that govern the activities in the Sample Room. QA would also ensure that there are effective linkages with Sample Room procedures and other parts of the Quality Management System. Performing the activities associated with Sample Room belong to Quality Control (QC) since the activities are part of the lab testing functional processes. Think of QA as having oversight and not burdened with much of the "doing." Otherwise, QA would be overseeing its own work.

  12. Why QA Head should not report to the Plant Operation?

    1. Conflict of interest. If you (Plant Operations) control my (Quality) performance review and paycheck, I may be feel pressured to please you to survive the job, rather than exercise independent judgment.

  13. The FDA expectation is that QA will exercise its responsibility independently. That's rather difficult to do when your boss is responsible for making the product that you are tasked with releasing. I have seen far too many examples where QA does not have the fortitude to disagree with their boss who does their performance review. A QA professional may be characterized as "not a team player" or "fails to make decisions in best interest of the business", which is veiled language for: You rejected my product. In my experience, the unique role of QA is rarely appreciated by the plant manager when it comes right down to making the monthly financials.