Keeping an Eye on Quality

With infrequent inspections by regulatory authorities-and time lapses between the identification of a violation and remedial or regulatory action-patients place trust in the self-enforcement of quality practices by API and drug manufacturers. How is the bio/pharma industry addressing quality practices?

The number of warnings for API and drug product manufacturing nearly doubled from 2015 to 2016 (1). Typical warning letter violations included failure to validate processes, determine a root cause, implement corrective action and preventive action (CAPA) plans, establish or follow written procedures for the prevention of microbiological contamination, conduct routing environmental monitoring tests, and investigate unexplained discrepancies in batches. The agency also cited firms for the lack of quality plans, supporting data, control over data and laboratory records, and scientific evidence to support procedures.

In fiscal year 2016, FDA issued almost 700 Form 483 observations, slightly above the average issued in the previous three years (2). The most frequently cited observations were:

• Quality control unit procedures were not written or fully followed

• Scientifically sound laboratory controls or procedures were not employed

• Failure to thoroughly investigate discrepancies or failures in batches

• A lack of written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess

• Deficient environmental monitoring systems in aseptic processing areas.

What happens when FDA is not watching? In an industry-wide study, the editors of BioPharm International examined quality practices as described by experts in quality, regulatory affairs, analytics, and manufacturing and production roles at companies serving the US market. The results will be revealed in a session, Quality Practices: Meeting and Exceeding Regulatory Expectations, at the inaugural CPhI North America event (May 16-18, 2017) in Philadelphia.

The survey examined the role of the quality control department in a bio/pharma organization and its impact on GMPs, the prevalence of quality management systems and quality-by-design programs, factors contributing to quality problems, and the company’s approach to regulatory compliance.

Survey respondents also evaluated the performance and contributions of FDA in providing information to address quality-related problems; commented on the usefulness of FDA regulations, guidance documents, and agency staff expertise; and shared observations on key initiatives such as quality metrics, data integrity, and post-approval changes. Respondents also commented on actions FDA can take to improve the quality of drugs manufactured for the US market.

The study participants also commented on equipment failures, production errors, inadequate method development, and failures by the quality control team. Relationships with contract service organizations and materials and equipment suppliers--including quality agreements and supplier oversight--are also reviewed.

The presentation is scheduled for May 17 at 2:30-3:15 pm in the exhibit hall. Attendees with exhibit hall or higher passes are invited to attend this free session. See www.cphinorthamerica.com for details.

References

1. FDA, Inspections, Compliance, Enforcement, and Criminal Investigations,  accessed Dec. 20, 2016.
2. FDA, Inspection Observations,  accessed April 20, 2017.

Article Details

BioPharm International
Vol. 30, No. 5
Page: 6

Citation:

When referring to this article, please cite it as R. Peters, “Keeping an Eye on Quality," BioPharm International 30 (5) 2017.