Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP Requirement for Liquid Oral and Ointment Department

A pharmaceutical plant facility layout plays a pivotal role in manufacturing quality products throughout the pharmaceutical industry. It is very crucial to have a well-designed plant facility layout to utilize all the resources that are available in the best possible way. In a pharmaceutical plant facility, arrangement of various departments, machines, equipment, and facilities are done. The experimental work covered in this paper shows selection of workstations by “Universal Process Model.” The manufacturing department is an important aspect of production in the pharmaceutical industry. 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 ointment and liquid orals 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, comprehensive guidelines for designing. Further, the layout condition and the importance of layout planning, operation, and design of manufacturing of ointment and liquid orals were also studied. Route chart for understanding the complete manufacturing process, list of workstations based on Universal Process Model, the space requirement for every workstation of ointment and liquid orals was studied. The manufacturing department is calculated by operating and the non-operational area is included in the study. To design a pharmaceutical manufacturing department, a layout for ointments and liquid orals should be designed based on the consolidation guidelines 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. Finally, “Block Layout” was developed. Three layouts were proposed for the ointment and liquid orals department.