Standard Operating Procedures (SOPs) are an integral element of a pharmaceutical or medical device manufacturing quality management system. This guideline provides points to consider when writing SOPs for regulated processes and systems. Following these guidelines can help to ensure the clarity and readability of written instructions and facilitate training. In this piece, we’ll cover:
The Importance of a CAPA System
CAPA is an important part of the quality management system and is required by regulatory agencies such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Union (EU). A CAPA system must be implemented in order to maintain compliance with regulatory requirements, ICH Standards, and ISO standards. The importance of having a CAPA system in place is to identify and eliminate causes of problems in a timely and effective manner, in order to prevent or minimize the risk of adverse events or product failures. Overall, this helps to protect the public and maintain the safety and integrity of medical device or pharmaceutical products.
The US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Union (EU) have established guidelines and requirements for the implementation of CAPA in the medical device and pharmaceutical industries. These requirements are outlined in regulatory documents and guidelines, such as FDA’s 21 CFR Part 820 – Quality System Regulation, EMA’s ICH Guideline Q10 on Pharmaceutical Quality System, the European Union Medical Device Regulation (EUMDR), and ISO 13485:2016 for Medical Device Quality Management Systems. These documents apply to the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use and the systems supporting the development and manufacture of pharmaceutical drug substances. Some of the specific requirements for CAPA include:
- Establishing and maintaining procedures to identify, document, correct, and prevent causes of nonconforming products, deviations, or other problems or potential problems in the quality system.
- Conducting investigations to determine the root cause of nonconformities and developing corrective actions to address the root cause.
- Implementing corrective actions in a timely manner and verifying that the actions are effective in preventing the recurrence of the problem.
- Documenting the CAPA process and maintaining records of all CAPA activities.
- Reviewing and evaluating the effectiveness of the CAPA process on a regular basis to ensure that the system is working as intended.
It is important for medical device and pharmaceutical companies to carefully follow these requirements to ensure compliance with regulatory requirements and industry standards and to maintain the safety and effectiveness of their products.
What Triggers CAPA?
Nonconformities, deviations, and other issues in a manufacturer’s quality system can trigger the need for a CAPA. A CAPA may be necessary for a single event with a high severity of potential harm or a CAPA may be necessary for a response to a trend or series of similar events, even if the severity of potential harm is not high. These issues can be identified through a variety of sources, including:
- Customer complaints in which customers report problems or adverse events related to the use of a medical device or pharmaceutical product.
- Internal audit observations.
- Regulatory inspection observations.
- Product testing in which testing of medical devices and pharmaceutical products yields out-of-specification (OOS) results (Note that typically one single OOS result does not require a CAPA, but multiple OOS results, especially those with a similar root cause, should be escalated to CAPA).
- Monitoring of processes and systems (e.g., management review, periodic trending reports).
- Incident reports that describe adverse events or other problems that occur during the use of a medical device or pharmaceutical product.
What Does a CAPA Look Like?
When a nonconformity, deviation, or quality problem that meets the company’s procedural requirements for escalation to CAPA is identified, an immediate correction may be warranted, followed by a thorough investigation to determine the root cause of the problem, and a plan is developed to correct the problem and prevent it from occurring again in the future. A thorough investigation to determine the root cause of a problem is an important step in the CAPA process. The goal of the investigation is to identify the underlying cause of the problem and implement a corrective action, rather than just addressing the symptoms with an immediate correction. This is important because addressing the root cause of the problem will prevent the problem from occurring again in the future. This may include changes to processes, procedures, or the product itself.
A CAPA should be initiated when a nonconformity or potential problem is discovered. A CAPA report is a document that outlines the steps that will be taken to address a problem or potential problem in a medical device or pharmaceutical product, process, or system. This is an important part of the CAPA process because it helps to ensure that the problem is properly addressed and corrected in a timely and effective manner. The CAPA report should include a detailed description of the problem, a thorough investigation with objective evidence, the root cause of the problem, and the corrective and preventive actions that will be taken to address the problem. It should also include a timeline for implementing the actions and a plan for verifying that the actions are effective in preventing the recurrence of the problem. This helps to ensure that the problem is properly addressed and that any corrective and preventive actions are effective in preventing the problem from occurring again in the future. It also helps to ensure that the CAPA process is conducted in a consistent and systematic manner and that all necessary documentation is collected and maintained.
CAPA is a critical component of a manufacturer’s quality system and is an ongoing process. The CAPA process must be continuously monitored and reviewed to ensure that it is effective and that any identified problems are properly addressed. Ultimately, a strong and effective CAPA process will help maintain the safety and effectiveness of products and processes.
