Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP Requirement for Tablets and Capsules Manufacturing Department

The manufacturing department is an important aspect of production in the pharmaceutical industry. It is responsible for the manufacturing, compression, and coating of tablets and capsules and ensure that cGMP rules are in place for manufacturing. A pharmaceutical department must be expertly managed and run for the company to protect and distribute a quality product. The layout and design of premises must aim to minimize the risk of error and permit effective cleaning and maintenance to avoid cross-contamination. In view of this, the designing of the pharmaceutical tablet- and capsule-manufacturing department should be as per the cGMP guidelines. The objective of this study was to design a manufacturing department based on international regulatory requirements utilizing consolidated, comparative, guidelines for designing. Further, the layout condition and the importance of layout planning, operation, and design of manufacturing of tablets and capsules were also studied. Determination of pallet space by calculation for storage of various categories of material, using various drug formulations with their per day production unit. A flowchart to help you understand the entire manufacturing process, a list of workstations based on the universal process model, and the amount of space needed for each workstation for tablets and capsules are all included. The manufacturing department is calculated by operating and the non-operational area, which is included in the study. According to the experimental study carried out for designing of pharmaceutical manufacturing department layout of tablets and capsules based on the consolidated guidelines and layout comparison to design and construct an effective manufacturing department to prevent the entry of dirt, dust, insect, and vermin. The interior surface of the manufacturing department must be (wall, floor, and ceiling) smooth and free from cracks and have a proper storage area to meet the temperature condition of various materials.