Undergoing a GxP-compliance regulatory inspection is a challenge for any company or site staff. Since various individuals, and even multiple departments, participate in inspections, you need a high level of pre-inspection organization and planning. In previous blogs,...
What is a CAPA? It is the acronym given to Corrective and Preventative Action, as defined by the FDA. A CAPA is triggered when a product, process, or documentation has a non-compliance issue. CAPAs can be triggered from small or large issues. A small issue might be repeated product loss from intermittent equipment error. Whereas a more significant CAPA trigger results from errors in product packaging that trigger a Form 483 from the FDA.
If you are in the pharmaceutical, biotechnology, or healthcare industries, you need proper CAPA support to bring your systems back to an acceptably maintained, calibrated, and validated condition. Solutions can range from small procedural changes to system redesign/revalidation. CAPAs are put in place for regulatory compliance but also reliable and profitable operations.
Who is the right team to investigate, document, solve, and resolve the issue?
CAPA investigation: Who? What? Where? When? and Why?
The parameters of a CAPA problem need to be correctly defined. Each CAPA investigation can be unique since there can be a single or several different root causes. Often a team is required with different areas of expertise to bring up all possible scenarios.
Areas of investigation can include:
- Equipment evaluation: For example, verifying vendor utilities as specified versus what was installed.
- Software evaluation: Code check if the proper alarms were programmed and work properly.
- Equipment comparison. For example, do similar pieces of equipment have the same problem? If not, what is the difference? These differences could be in process parameters, design, etc.
- Test runs: Physically test potential change controls before implementing (e.g., ramp rates, alarm settings, and proposed software changes) and return to the currently validated state.
- Operations evaluation: For example, does the event occur on a specific shift/operator time, times of the year, during other operation events, or only for certain product sizes?
- Interviews: Personnel such as Operators, Mechanics, and Supervisors may have knowledge that the area engineers don’t have. Use them; they appreciate the acknowledgment of their operations knowledge.
- Prior CAPA investigations: Sometimes, similar CAPAs for systems and equipment have occurred in the past outside of the effectiveness monitoring period. Information from these CAPAs will help to avoid the same mistakes, or even provide a forgotten solution.
CAPA Mitigation: How to minimize risk while work is progressing?
CAPAs take time to solve. A good risk assessment will help mitigate risks while the CAPA work proceeds.
Examples of mitigations can include:
- Operations Changes: For example, a reverse osmosis (RO) water system trips from low flow on Monday mornings. The short-term mitigation would be staggering cleaning systems’ use of RO until the situation was remediated. Another example is switching problematic processes to another line that doesn’t have that problem.
- Awareness Training: For the RO system example, operators and supervisors would be made aware of the situation so they could check usage before starting their work.
- Documentation: Document all events after CAPA has started to help see if additional causes exist and if mitigations are helping.
CAPA Activities & Documentation:
CAPA investigations generate a probable list of root causes. Each root cause will have its own activities and documentation.
Types of CAPA activities and the documentation required:
- Correction: Example – Replace a failed sensor or equipment component. Documentation includes the basic maintenance work order.
- Corrective Action: Example – Change calibration or maintenance schedules due to reliability. Documentation includes SOP changes.
- Preventative Action: For example, repair PLC control code to mitigate missing alarms or proper pump priming. This example would be a weekend software validation change control.
CAPA Effectiveness Monitoring / Closure:
After CAPA activities are completed, there will be a period of Effectiveness Monitoring before CAPA closure. If effectiveness monitoring fails, the CAPA will revert to the investigation phase. Successfully closing a CAPA will result in greater equipment uptime and remediate regulatory compliance issues.
PSC Biotech has experienced and efficient CAPA investigation and support services.
If you need CAPA Investigation and technical support service, contact PSC Biotech®. Our professional services group has the right technical expertise to ask the right questions and help solve your CAPA problem in a timely manner.
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