Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.

In recent years, the trend in the pharmaceutical, biopharma, and device industries has been to devote more attention to holistic quality systems and to ensure standardization of the company’s overall quality systems rather than using process-by-process policies that may or may not align completely. The 2015 changes to ISO 9001 and ISO 14644-1 and -2 standards have magnified the industry’s focus on risk assessment and quality management systems, integrating and unifying our approach to ensuring quality across all aspects of pharmaceutical, biopharma, and medical device manufacturing.

Typically, supplier management programs use a supplier survey or an on-site audit to verify if a supplier is compliant with the requirements of a standard or regulation. However, for a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation. A value-added supplier management program should also consider items such as supplier capability, capacity, and contingency planning.

This two-part article focuses on risk management of facilities and equipment. It describes how a risk-based approach to facilities and equipment management fits into an integrated, effective quality systems structure. The principles discussed are equally applicable to all quality systems. The focus is on facilities and equipment because they represent a broad range of risk to product quality and are one of the key quality systems commonly identified in the pharmaceutical manufacturing industry.