Guidelines: Production

Production covers all operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing, packaging and repackaging, labelling and relabelling, to completion of the finished product. 

WHO good manufacturing practices  

Good manufacturing practice (GMP) is that part of a quality management system to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production; which may broadly be categorized into two groups: (1) cross-contamination/mix-ups and (2) false labelling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy.  For this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.