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The Role of the Pharma Quality Unit

Pharma Quality Unit Top 10 Responsibilities

Did you know the Quality Unit is the only job description that appears in the Code of Federal Regulations? We’ve outlined the FDA regulations and guidance documents that define the job of the Quality Unit below. The pharma Quality Unit is responsible:

1) To Establish the Quality System

  • The Quality Assurance Unit must establish the quality management system to describe how the company complies to cGMPs and operates in a state of control.
  • Additionally, they are tasked with keeping the quality management system current with good industry practices.

2) To Describe Responsibilities in Writing

  • Complete procedures that describe the responsibilities of the Quality Unit must be in place.
  • Adherence to the procedure is mandatory, and strong Quality Unit leadership is integral in ensuring that established procedures are being followed.

3) To Audit Compliance to the Quality System

  • The Quality Assurance Unit must carry out regular audits for compliance to policies and procedures are essential to confirm that the procedures and policies on paper align with practices.
  • Quality metrics need to be reported regularly, including trends that aid in decision-making and bring about proactive, targeted actions.

4) To Remain Independent

  • Above all, the Quality Unit must remain an independent reviewer and approver with respect to manufacturing and process/ product development units.
  • In order for the Quality Unit to remain independent, the organization must ensure that no conflict of interest exists between regulatory responsibilities and daily activities.

5) To Establish Procedures and Specifications

  • The pharma Quality Unit must make certain that procedures and specifications are appropriate and followed.
  • They must also ensure that the procedures and specifications of companies under contract are also appropriate and followed, maintaining control and taking responsibility for third-party providers (contract manufacturers, contract laboratories, etc.)

6) To Establish Manufacturing Controls

  • It is the responsibility of the Quality Assurance Unit to ensure that appropriate manufacturing in-process controls are implemented.
  • They must also make sure that in-process controls are performed during manufacturing operations and results are in specification.

7) To Review Laboratory Tests or Examinations Performed

  • The Quality Assurance Unit must approve or reject drug products manufactured, processed, packaged, or held under contract by another company. In short, a contractor may not release the final product.
  • As part of this responsibility, the Quality Assurance team reviews data generated by laboratory testing using validated methods against scientifically-derived specifications. This includes the review of data generated from the analysis of components, containers, in-process materials, packaging materials and drug product.
  • Additionally, they must perform retests or reexaminations of approved components, drug product containers and closures after long storage or exposure to adverse conditions.

8) To Review and Approve or Reject All Things cGMP

  • The Quality Assurance Unit must review and approve or reject any document that details work instructions and sets specifications, such as procedures, protocols, and test methods. They are also responsible for reviewing, approving, or rejecting any changes to these documents.
  • Additionally, the Quality Unit reviews and approves or rejects reprocessing and rework procedures, as well as production batch records. To summarize, the Quality Assurance Unit makes the final decision to release a product lot for use.

9) To Ensure Investigation of Nonconformance

  • The pharmaceutical Quality Unit reviews complaints to determine if they relate to a failure to meet specification, and if so, the Unit investigates and reports to FDA, if needed.
  • They must also ensure the investigation is performed and the root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes.

10) To Keep Management Informed

  • In addition to reporting on product, process and system risks, they must also report the outcome of regulatory inspections, as well as ensure responses are complete and managed to closure, while keeping management informed of all updates.
  • The Quality Unit is responsible for holding regular management review meetings to keep management informed and ensure that they understand the updates and information being conveyed.



Carla Totton, Avomeen Head of Quality AssuranceOur expert blogger is Carla Totton, Avomeen’s Quality Assurance Manager. Carla has a decade of experience working in the pharmaceutical industry and has been ASQ CQA certified for the past 4 years. Throughout her career, she has effectively coordinated all functions of an internal QA organization, including the development, implementation, and monitoring of quality systems and procedures.