Documentation

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 intermediate and semi finished products and finished products as well as detailed testing methods as per 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 process and cleaning validation ,SOP for sampling as well as its calibration and maintainace, SOP for sampling and product retain, SOP for environmental control and water treatment, SOP for animal test, SOP for product recall, handling of products complains, stability study, and SOP for self audit, etc.