Compliance audits present their own orientation to an organization that wants to present the perfect front while being asked to air their dirty laundry. Is this inspection about smoke and mirrors or does the audited facility present a ‘zipped-tight’ posture toward the investigator? Continue reading
Many companies will try to resolve compliance actions by the Food and Drug Administration (FDA) through the use of an electronic document management system (EDMS) approach that is typically post mortem.
This is risky business at two critical levels. First, no EDMS approach will replace the operation of a comprehensive quality management system (QMS) that describes the integration of necessary GxP (compliance) driven quality processes. Secondly, the response will need to have a litany of justifications for a retrospective systematic approach. This is like trying to perform process validation on pre-existing production of unqualified products: it’s bad business! Continue reading
FDA classically has defined the requirements for validation under 21 CFR 820 and 210/211 regulations as a comprehensive testing process where all systems are given thorough examination and tested under equal weight, complete with an exhaustive evaluation process.
Recent guidance and initiatives by FDA (Process Validation: General Principles and Practices) and ICH (Q11: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES) have provided a streamlined risk based approach under an updated life cycle management methodology. Under this scenario, a new definition of validation has emerged, best described by FDA as;
“the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”
This is in contrast to the classical definition as perhaps best emphasized in the device regulations under 21 CFR 820.75:
“Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.” Continue reading
Most of us in the pharmaceutical and biopharmaceutical industry are very familiar with the terms corrective action & preventative action (CAPA) and commonly associate it exclusively with quality and manufacturing.
However, CAPA can be applied to many different business areas within an organization, including clinical research. A CAPA consists of a collection of tasks and actions executed to ensure and sustain quality and compliance in day-to-day processes. In clinical research, noncompliance can be extremely costly, both directly and indirectly. Continue reading
Anyone working in quality management is familiar with references to “Death by CAPA” or “CAPA Kills.” The industry is rife with similar catch phrases. The “truth” is they are not far from the “truth.” When my friend from FDA originally coined the expression “death by CAPA,” it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all that needed to be examined was always caught. To avoid your own CAPA calamity, let’s examine two key distinguishing features of a good approach to CAPA management. Continue reading