What are the tasks and functions of the Quality Assurance department/ Quality Unit in the pharmaceutical industry?

It is important to note that a Quality Assurance department is not explicitly required by EU regulations in the pharmaceutical industry (for the manufacture of medicinal products). Nevertheless, such a department has become established in virtually all manufacturing companies. The GMP guidelines do not assign any direct responsibilities or clear tasks to the head of such a department, unlike other functions such as head of manufacturing, head of quality control or qualified person. There is only one reference to such a function in the relevant regulations on the manufacture of medicinal products, namely in the EU GMP Guidelines, Part 1, Chapter 2.9: "The heads of Production, Quality Control and, where relevant, Head of Quality Assurance or Head of Quality Unit, generally have some shared or jointly exercised responsibilities relating to quality, including in particular the design, effective implementation, monitoring and maintenance of the quality management system."

The situation is different for the manufacture of active pharmaceutical ingredients. The EU GMP Guidelines Part 2, Chapter 2.13 states: "There should be a quality unit(s) that is independent of production and that fulfils both quality assurance (QA) and quality control (QC) responsibilities. This can be in the form of separate QA and QC units or a single individual or group..."

In principle, this reflects quite well what has become established in manufacturing medicinal products. These departments are responsible for establishing, maintaining and updating a pharmaceutical quality assurance system.

Article 6 of Directives 2003/94/EC (and 91/412/EEC) obliges manufacturers to establish and implement such a pharmaceutical quality assurance system, which is then described in more detail in the EU GMP Guidelines Part 1, Chapter 1. According to this, the holder of a manufacturing authorisation must manufacture medicinal products in such a way that they are suitable for their intended use, comply with the requirements of the marketing authorisation (or clinical trial authorisation) and do not endanger patients due to inadequate safety, quality or efficacy. Achieving this quality objective is the responsibility of senior management and requires the cooperation and commitment of employees in many different departments and at all levels of the company, as well as the company's suppliers and distribution partners. In order to reliably achieve this quality objective, a comprehensively designed and correctly implemented pharmaceutical quality assurance system must be in place, which includes good manufacturing practice (GMP) and quality risk management principles. It should be fully documented and its effectiveness monitored.

In its Guidance for Industry - Quality Systems Approach to Pharmaceutical CGMP Regulations, U.S. FDA distinguishes more precisely between QC and QA functions: "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, labelling, 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."

To reflect this, the guideline refers to the Quality Unit (QU).

This is in line with the basic thinking in the EU, that the QU has the authority to establish, monitor and implement a quality system. These activities do not replace or exclude the daily responsibility of manufacturing personnel for product quality assurance. The QU should not take over the tasks of other departments within a manufacturing organisation. Both the manufacturing personnel and the QU are crucial to fulfilling the manufacturer's responsibility to produce high-quality products.

Guideline ICH Q10 (Pharmaceutical Quality System), which is also part of the EU GMP guidelines (Part 3), describes a comprehensive model for an effective pharmaceutical quality system that is also based on the quality concepts of the International Organisation for Standardisation (ISO), encompasses applicable Good Manufacturing Practice (GMP) regulations and supplements the ICH Q8 'Pharmaceutical Development' and ICH Q9 'Quality Risk Management' guidelines. ICH Q10 is a model for a pharmaceutical quality system that can be implemented in practice during the various phases of the product life cycle.

Important elements of a pharmaceutical quality system according to ICH Q10 are:

• Process performance and product quality monitoring system
• Corrective action and preventive action (CAPA) system
• Change management system
• Management review of process performance and product quality

EU GMP Guidelines Part 1, Chapter 1 adds the following:

• Self-inspection
• Product Quality Review
• Quality Risk Management

It is essential that:

• All manufacturing processes are clearly defined and verified,
• Critical steps in the manufacturing processes and significant changes to the process are validated,
• All facilities required for GMP are available,
• Instructions and procedures are written in clear and unambiguous language in the form of manuals,
• The procedures are carried out correctly and the operators are trained to do so,
• All significant deviations are fully recorded, the cause is determined and appropriate corrective and preventive actions (CAPA) are implemented,
• Records of manufacturing, including distribution, enable complete traceability of a batch,
• A system is in place to recall any product batch,
• Complaints are investigated, the causes are examined and appropriate measures are taken.

The elements described in the list above are at least supported or comprehensively created, monitored and implemented by quality assurance.

Please see in this context the available GMP training on general QA topics and GMP compliance.