Standard operating procedures for quality control in the pharmaceutical industry

Abstract

Objectives: To develop quality control standard operating procedures (SOPs) and to highlight the importance of implementation and use of these SOPs in the pharmaceutical industry. Method: A pharmaceutical company, Aurobindo (Swift services), was regularly visited three times per week over a five-month period. The visits consisted of familiarisation visits followed by visits for induction and specific training. A set of SOPs were selected, developed and implemented. Key findings: Nine SOPs were developed and implemented. Seven SOPs were developed using a simple format and two SOP s were developed in the form of flow chart. The average time taken to carry out a procedure was recorded and included in eight SOPs. Conclusion: SOPs are tools which when followed correctly ensure the consistency of a process. This is important in the pharmaceutical industry to achieve high standards of quality. Inclusion of the time taken to carry out a procedure gives an indication to the user whether the task was carried out as expected.