Standard operating procedures in pharmaceutical quality systems

Abstract

Objective: To develop explanatory texts for a pharmacy curriculum and reference textbook and to develop model standard operating procedures (SOP s) on key quality and operational pharmaceutical activities. Method: Explanatory texts were written and model SOP s were developed. Emphasis on clarity, conciseness and user-friendliness was made when selecting the writing style and format of the documents. Key Findings: Three explanatory texts entitled ‘Master Standard Operating Procedure’, ‘Preparing a Standard Operating Procedure’ and ‘Good Manufacturing Practice’ were compiled and sixteen model SOPs were developed. Conclusion: Effective SOPs are required to achieve compliance with regulatory requirements and good practice guidelines. Explanatory texts and model SOP s are provided to assist in the development of a pharmaceutical quality management system. The texts developed are an effective training tool on the development of good quality SOPs and the model SOPs are an example of the good quality procedures being recommended.