The number one reason for getting a 483 or a Warning Letter from the FDA is:
The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed. [CFR 211.22(d)].
So, the questions are:
What are the responsibilities of the Quality Unit?
What is the difference between Quality Control, Quality Assurance and the Quality Unit as the FDA defines it?
The following is quoted form the FDA Guidance – Guidance for Industry -Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
The Quality Unit
Many of the modern quality system concepts described here correlate very closely with the CGMP regulations (refer to the charts later in the document). Current industry practice generally divides the responsibilities of the quality control unit (QCU), as defined in the CGMP regulations, between quality control (QC) and quality assurance (QA) functions.
QC usually involves (1) assessing the suitability of incoming components, containers, closures, labeling, in-process materials, and the finished products; (2) evaluating the performance of the manufacturing process to ensure adherence to proper specifications and limits; and (3) determining the acceptability of each batch for release.
QA primarily involves (1) review and approval of all procedures related to production and maintenance, (2) review of associated records, and (3) auditing and performing/evaluating trend analyses.
This guidance uses the term quality unit (QU) to reflect modern practice while remaining consistent with the CGMP definition in § 210.3(b)(15). The concept of a quality unit is also consistent with modern quality systems in ensuring that the various operations associated with all systems are appropriately planned, approved, conducted, and monitored.
The CGMP regulations specifically assign the QU the authority to create, monitor, and implement a quality system. Such activities do not substitute for, or preclude, the daily responsibility of manufacturing personnel to build quality into the product. The QU should not take on the responsibilities of other units of a manufacturer’s organization, such as the responsibilities handled by manufacturing personnel, engineers, and development scientists.
- Manufacturing personnel and the QU are both critical in fulfilling the manufacturer’s responsibility to produce quality products.
- Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches (§ 211.22):
- Ensuring that controls are implemented and completed satisfactorily during manufacturing operations
- Ensuring that developed procedures and specifications are appropriate and followed, including those used by a firm under contract to the manufacturer
- Approving or rejecting incoming materials, in-process materials, and drug products
- Reviewing production records and thoroughly investigating any unexplained discrepancies (and establishing effective corrective and preventive actions)
Under a quality system, it is expected that the product and process development units, the manufacturing units, and the QU will remain independent. In very limited circumstances, a single individual can perform both production and quality functions. That person is still accountable for implementing all the controls and reviewing the results of manufacture to ensure that product quality standards have been met. Under such circumstances, it is recommended that another qualified individual, not involved in the production operation, conduct an additional, periodic review of QU activities.
Three key words to remember for the Quality Unit-
Responsibility – Authority – Independence
In summary, here are the basic responsibilities of the Quality Unit (and cannot be delegated to any other department):
- Making a final decision regarding release or rejections.
- Review and approve all appropriate quality-related documents.
- Establishing a system to release or reject all materials, in-process goods, and finished products.
- Reviewing completed batch production and laboratory control records of critical process steps before release of final product for distribution;
- Making sure that critical deviations are investigated and resolved;
- Approving all specifications and master production instructions;
- Approving all procedures impacting product quality.
- Making sure that internal audits (self-inspections) are performed; Approving suppliers, vendors, contract manufacturers and contract test laboratories;
- Approving changes that potentially impact product quality;
- Reviewing and approving validation protocols and reports;
- Making sure that quality related complaints are investigated and resolved;
- Making sure that effective systems are used for maintaining and calibrating critical equipment;
- Making sure that materials are appropriately tested and the results are reported;
- Making sure that there is stability data to support retest or expiry dates and storage conditions of products and components and
- Performing product quality reviews