From quality issues with Johnson & Johnsons’ infant pain reliever to contaminated high blood pressure medication, we all know too well the problems that can occur when mistakes happen in API manufacturing. The role of quality is paramount, since the implications of poor quality are too big to ignore.
Quality is so important in biopharma that it is falls under several different departments and programs at most firms, and there is a clear distinction between Quality Assurance (QA) and Quality Control (QC). To generalize them, Quality Assurance refers to the processes implemented and actions taken to proactively design and manufacture safe and effective drug ingredients. Quality Control is the more reactive program, which inspects and tests to verify that the API is safe and effective after it has been produced and it also is responsible for all of the documentation. According to current Good Manufacturing Practices (cGMP), QC is required, yet it is more vague about requirements for QA.
Yet regardless of the protocols implemented and rules followed in QA and QC, issues arise that can compromise the quality of projects and plants. There can be excess impurities in the API manufactured, standard operating procedures (SOPs) for handling equipment or maintaining clean rooms can be compromised, or documentation can contain errors. Regardless of the problem, every situation can be a lesson learned.
In fact, in addition to raw materials testing, in-process monitoring, release and stability testing and process validation, investigation of deviations from quality are required by the FDA as part of cGMP compliance.
According to FDA guidelines, meaningful investigations should be thorough, timely, unbiased, well-documented, and scientifically sound. The first phase of a quality investigation should include an initial assessment of the accuracy of the laboratory’s data. If this initial assessment indicates that no meaningful errors were made in the analytical method used to arrive at the data, a full-scale Out-of-Specification (OOS) investigation should be conducted.
Regardless of whether it’s required by the FDA or an internal issue, the key to learning from the mistake is to conduct a quality investigation. At Seqens CDMO NA, quality investigations are performed in response to any deviation from our SOPs or product specifications. As part of the investigation, we review and analyze the circumstances in which the deviation occurred to get to the root cause and its impact on products, processes, systems or staff.
We have a specially assigned Quality Assurance Group, responsible for initiating a quality investigation immediately upon notification of an issue. All pertinent facts from the investigation, notes and documentation are included to provide a comprehensive narrative and to ultimately assign a root cause. A thorough impact assessment also is performed to identify all corrective and preventative actions that should be taken, to not only rectify the situation but prevent it from happening again in the future.
CDMOs that strive for quality in every aspect of their operations are rewarded with successful projects, happy sponsors and safer staff. And, while issues will always arise that could jeopardize quality despite the best efforts, those CDMOs that have a plan in place and act quickly and honestly to rectify and learn from them, can minimize the severity and frequency of such issues and grow from them.
For other articles about quality control-related issues, check out Successful Audits in API Manufacturing Begin and End with Ongoing Quality Processes; or Incomplete Documentation Can Make or Break API Manufacturing Projects.