The pharmaceutical industry, as a vital segment of the healthcare system, conducts research and manufactures and markets pharmaceutical and biological products and medical devices used for the acute/chronic treatment and diagnosis of disease.
Recent advances in drug discovery, primarily in the field of biotechnology and in the required controls over manufacturing processes, are presenting new challenges to the control of quality and to the systems that operate internally in the industry. The external regulations established by the federal Food and Drug Administration (FDA) and other regulatory bodies also add to these challenges.
The evolving role of the industrial quality professional requires more extensive education including food and drug law, business, as well as the traditional science/technology coursework.
Quality assurance (QA) and quality control (QC) departments develop and follow standard internal operating procedures directed toward assuring the quality, safety, purity, and effectiveness of drug products. The FDA has issued a primary regulation to the industry entitled Current Good Manufacturing Practice for Finished Pharmaceuticals (commonly referred to as the cGMPs or GMPs).
Numerous guidelines have been issued relative to specific dosage forms and operations such as aseptic manufacturing, validation and stability testing, etc., which impose significant compliance requirements. These guidelines also serve as the basis for compliance investigations conducted by the FDA and are used in regulatory agency inspections of facilities and operations.
QA Functions and Responsibilities
The QA department within any organization, because of its responsibilities, normally will report to a relatively high-level administrator within a company, depending on its size. In smaller companies they may report to the chief executive officer or the president. In larger corporations, they will sometimes report to the president or executive vice-president or chief of operations. In any case, however, responsibility for quality, as currently dictated by FDA, ultimately resides with top management which has responsibility for ensuring that appropriate resources are provided to meet all quality and compliance requirements. In all cases, the QA department will be independent of the economic issues associated with manufacturing and distribution of the product.
The QA department is responsible for ensuring that the quality policies adopted by a company are followed. In some organizations, QA serves as the primary contact with regulatory agencies and is the final authority for product acceptance (release) or rejection. It is customary for QA to play a major role in the identification and preparation of the necessary policies and standard operating procedures (SOPs) relative to the control of quality.
A second major responsibility of the QA department is the quality monitoring or audit function. Through this activity, it is able to determine if operations have adequate systems, facilities, and written procedures to control the quality of products produced. Thus, the QA function not only determines that the procedures are current and correct, but that properly trained operators are following them.
QC Functions and Responsibilities
Quality Control is responsible for the day-to-day control of quality within a company. This department is staffed with scientists and technicians responsible for the sampling and analytical testing of incoming raw materials and inspection of packaging components, including labeling. QC conducts in-process testing when required, performs environmental monitoring, inspects operations for compliance, and conducts the required release tests on finished dosage form. Finally, QC is responsible for monitoring product quality through distribution, including testing of product complaint samples, evaluating product stability, and so on.
Many companies have the heads of QC and production report to a common higher level of management, but with QC being independent of production. This higher-level management may be the same or different individuals, but it allows independent operation of both functions without direct conflict arising when reaching a final decision on the acceptability of final products.