CAPA Meaning and Need of CAPA in Pharma Industry

First thing First, CAPA Stands for Corrective and Preventive Actions

Many pharmaceutical companies today lack good CAPA application and diversion management. These circumstances seriously compromise the quality of the products and question the efficiency of the laboratories. So we want to review how corrective and preventive actions are applied.

The risk in pharmaceutical manufacturing corresponds to an event that compromises the quality, efficacy and safety of the products. So it is evident that it is more than necessary to control it. In order to comply with the regulations, avoid non-conformities and protect the public, you will have to evaluate your production process.

With this in mind, it is important to understand that corrective action will not necessarily resolve the nonconformity or deviation that has occurred. In fact, it only corresponds to an event simultaneous to the appearance of the fault or after it has happened to control its reappearance. Instead, preventive action is intended to prevent nonconformity, even if it has not occurred.

How the CAPA system works

In order to evaluate the events, determine the methodology, identify the root cause and do an investigation,

The incorporation of CAPA systems is of great help in optimizing processes in the pharmaceutical industry.

Firstly, Corrective Action is not the action that resolves the nonconformity, this is one of the most common misunderstandings. "I detected this nonconformity and resolved it with this corrective action" is one of the most mistaken phrases. The action to take to resolve a nonconformity is Correction. The Remedial Action is the action taken simultaneously with the non - conformity or once resolved, to prevent their recurrence in the future. While Preventive Action prevents the occurrence of any nonconformity that has not yet occurred (or to manage an improvement)

CAPA Generally performed in following steps:

Analyze the problem ,

define the impact it had on the quality of the product and on the effectiveness of the process, as well as the estimation in terms of severity and probability of occurrence (or repetition). Apply a risk management process;

Define a method to identify the root cause or, at least, the most probable. For example, with the 5 whys rule, a succession of five questions that allow you to get to the bottom of the problem. Example:

(first why) - Why does the X team in line Y in production not work?

(second why) - Why is the Z component of team X broken?

(third why) - Why hasn't component Z been replaced for two years, even though the manufacturer indicated the need for an annual replacement?

(fourth why) - Why was the scheduled maintenance not carried out?

(fifth why, the root of the problem) - Why have the maintenance staff resigned and not yet been replaced?

Identify the root cause.

FDA inspectors and Americans in general have always preferred the checklist. The bible in this case is The Checklist Manifesto

Describe in detail the investigation

So that whoever is not inside my head can reconstruct the reasoning carried out in points 1 and 2;

If an investigation is not carried out, you must explain why, by providing a justification based on objective criteria (the investigation has already been carried out in non-conformity / linked complaint No. x, it is at a percentage of defect historically accepted and documented, etc.).