Quality Assurance and the Control of Microbial Risk in Medicines

QUALITY  ASSURANCE  AND  THE  CONTROL  OF MICROBIAL  RISK  IN  MEDICINES

INTRODUCTION

Manufacturers of medicinal products must comply with the requirements of their marketing authorization (product licence) and ensure that their products are fit for their intended use in terms of safety, quality and efficacy. A quality management system (QMS) must therefore be in place so that senior management can ensure that the required quality objectives are met through a comprehensively designed and properly implemented system of quality assurance (QA), encompassing both GPMP and quality control (QC).

QA encompasses, in turn, a scheme of management which embraces all the procedures necessary to provide a high probability that a medicine will conform consistently to a specified description of quality. It includes formulation design and development (R&D), GPMP, as well as QC and post-marketing surveillance. As many microorganisms may be hazardous to patients or cause spoilage of formulations under suitable conditions, it is necessary to perform a risk assessment of contamination for each product. At each stage of its anticipated life from raw materials to administration, a risk assessment should be made and strategies should be developed and calculated to reduce the overall risk(s) to acceptably low levels. Such risk assessments are complicated by uncertainties about the exact infective and spoilage hazards likely for many contaminants, and by difficulties in measuring their precise performance in complex systems. As the consequences of product failure and patient harm will inevitably be severe, it is usual for manufacturing companies to make worst-case presumptions and design strategies to cover them fully; lesser problems are also then encompassed. As it must be assumed that all microorganisms may be potentially hazardous for those routes of administration where the likelihood of infection from contaminants is high, then medicines to be given via these routes must be supplied in a sterile form, as is the case with injectable products. It must also be presumed that those administering medicines may not necessarily be highly skilled or motivated in contamination control techniques; additional safeguards to control risks may be included in these situations. This may include detailed information on administration as well as training, in addition to providing a high quality formulation.