ABSTRACT

In pharmaceutical manufacturing facilities, support laboratories play the crucial role of testing the product to verify its quality, safety, and stability at each stage of the manufacturing process, packaging, and product release. These labs are referred to as quality assurance (QA) and quality control (QC) laboratories and exist to support the manufacturing operations of the facility. The design of QA/QC laboratories requires an understanding of the facility; the processes and equipment used in the lab; the hazardous materials present; the heating, ventilation, and air conditioning (HVAC) systems used; and other requirements. Consideration must be given to the safety and protection of lab personnel and the product. Despite their small size relative to the facility at large, QA/QC laboratories are necessary to the operation of the facility, and a thorough understanding of good design practices is necessary to guarantee the efficiency and viability of the facility.