If there has been a failing in one of your cannabis products or dietary supplements in your production facility, then you’re going to need to figure out what went wrong and how to prevent it from happening again. This is a part of GMP—Good Manufacturing Practices—in the food and pharmaceutical industries, and will also help you to achieve compliance.
Remember that failure to respond to an issue, consumer complaint, or delivering faulty products into the consumer market can cause production facilities to lose their licensing. It is best to follow GMP guidelines to prevent these things from happening and reduce risk.
What is CAPA?
CAPA basically means “Corrective Action Preventive Action”. Patients have a high level of trust when they purchase their cannabis products or dietary supplements. They trust that the products will work as prescribed and that they’ll be as safe as possible, with minimal side effects. Caregivers, physicians, and nurses also need to know that they can safely give these products to their patients.
CAPA is a process that solves problems. It will identify potential problems in the manufacturing processes, suggest corrective actions for what has gone wrong, and help to implement strategies for preventing it happening again in the future.
A strong CAPA program can save the company money and time by ensuring the same problems do not continue to reoccur. A good CAPA will be completely documented, ensuring that the investigation can be reviewed at a later date. This will allow managers to determine what preventative actions have worked in the past, and how to implement effective actions in the future.
Application of CAPA in Manufacturing
CAPA can be applied in many aspects of your manufacturing facility. It can be used for the specific manufacturing of a product, or in the product’s packaging or design. It can be used during the testing verification and validation process. It can be implemented for distribution, shipping, and transport too.
How to Implement CAPA
There are several steps involved in performing an effective CAPA.
The first step involves the realization of a problem. Questions may be asked which may need to be further defined later. A problem statement will then be asked that allows you to get deep into the problem. A diagram may be created to identify potential causes of the problem statement.
A description may be written up as to the Who, What, When, Where, Why, and How types of questions. Any potential causes to the problem may be reduced or eliminated. For what problems remain, theories may be developed. The problem may be tested to see if it can be turned on or off at will, or recreated. There will then need to be corrective actions done to ensure that the problem doesn’t occur again.
The active inspection phase may need to be adjusted, since it failed to identify the cause in the first instance. The final phase will be the actual implementation and validation of the final corrective action.
At times one minor problem may be part of a bigger issue. CAPA is also effective in determining hidden problems in the manufacturing process. The sooner you can perform an effective CAPA, the sooner you can find the root of a problem in your manufacturing process.
CAPA involve two distinct but related functions—corrective action and preventative action. Even though CAPA can be time-intensive, it can save you GMP production facilities from lost time and productivity in the future.