The Truth Behind cGMP Adherence

Pharma appears to be constantly plagued by drug shortages, recalls, warning letters, and import alerts despite increasing emphasis from regulators on efficiency and reliability in pharmaceutical operations. The past few years have witnessed a growing number of deviations, with breaches in data integrity frequently cited, causing an erosion of trust in the industry as a result.

Ajaz Hussain, founder and CEO of Insight, Advice & Solutions LLC, and a CPhI expert panel, highlighted in the 2016 CPhI Annual Industry Report, that although some progress has been made within the industry, many challenges remain. As noted in a FDA report, product recalls and defect reporting data demonstrate unacceptably high occurrences of problems attributed to inherent defects in product and process design. Moreover, there are no formal benchmarks for the current state of pharmaceutical quality; and because of inadequate quality surveillance, it is difficult to make decisions on risk.

Another challenge, according to the FDA report, stems from the current regulatory review and inspection practices, which continue to take the “one-size-fits-all” approach instead of considering specific risks to the consumer from product failure modes. Inspection and review functions remain disjointed and are not well-connected to knowledge gained from product application review and vice versa.

Hussain stressed in the 2016 CPhI Annual Industry Report, that part of the solution lies in addressing human factors, i.e., improving human centricity in pharmaceutical operational practices. As noted by FDA, patient-focused manufacturing, quality, and regulatory solutions demand an adequate emphasis on staff/operator-centric quality management system, policies, and procedures. Hussain feels that the industry is lacking in this area.

Human factors need to be more closely considered in designing manufacturing processes, he said. The industry often finds itself trapped in a mindset of “file first, figure it out later.” It tries to meet standards instead of improving quality. Hussain believes that employee empowerment is in need of attention and it begins with senior leaders making adherence to cGMP regulations and compliance with standard operating procedures (SOPs) the normal, easy, and rewarding thing to do.

Source: CPhI Annual Industry Report 2016