Documentation is an essential part of quality system. QA department is responsible for preparing and auditing all the documents according to criteria and standards concerning quality management. This includes documents for the specification of each raw materials and ingredients; semi finished products and finished products as well as detailed testing methods as per each pharmaceutical formulation.
All actions pertaining to manufacturing of pharmaceutical formulations are documented and reviewed regularly and updated. These includes Standard Operating Procedures (SOP) for performing various operation, such as SOP for each equipment operation and cleaning as well as its calibration and maintenance, SOP for process and cleaning validation, SOP for sampling and product retain, SOP for environmental control and water treatment, SOP for animal test, SOPs for product recall, handling of products complains, stability study, and SOPs for self audit, etc.
