Corrective Action and Preventive Actions

Corrective Action & Preventive Action in the pharma industry is more than a regulatory and standardization requirement. It is applied to all critical components of the pharma industry as a problem-solving technique and helps to prevent them in the future. CAPA also serves regulatory requirements for the pharma industries in most major markets, such as the United States and the EU. 

CAPA is an essential element of the pharma quality system. It is applied across all departments and functions of the pharma industry to implement, track, verify, and document the effectiveness of corrective and preventive actions. 

What is a CAPA?

CAPA is a technique to improve the existing process, system, and practices by studying the root cause of the failures and taking necessary steps to prevent them from occurring in the future. The CAPA system also intends to solve the current problem by proposing corrective actions to make the system operational until appropriate preventive actions are devised and implemented.

The overall purpose of a CAPA is to prevent problems and failures that a pharma organization routinely faces. Examples include product recalls or equipment breakdowns, which have a significant impact on the quality of the pharma process quality, and can also create compliance issues.  

With CAPA, a pharma organization has a defined system of communicating preventive and corrective actions to relevant responsible departments or personnel and can be tracked for system improvement and follow-up. Traditional communication systems, such as email or verbal communication, do not have any regulatory authority or significance and are prone to errors and other shortcomings.

It is necessary to record CAPA in a documented form for better implementation and to present it to the regulatory body during the routine inspection. The format of CAPA can take varying forms, but it should contain all the relevant information.

Acceptance criteria are also part of CAPA implementation, which is used to verify the CAPA result. 

Importance of CAPA

Many factors make the CAPA an important element of the pharma quality system, and some of them include the following. 

Information collection

CAPA allows for collecting information about the product or system's error or failure. Information collection is the hardest part of the problem-solving process, often affected by various factors such as failure to understand a system, lack of resources & mindset. All these factors make the information collection process difficult and erratic. 

CAPA allows pharma organizations to collect information accurately whenever a problem arises. It also enables the collection of information scientifically with proper resources and at a fixed frequency.

The information collected through CAPA can be used to implement various corrective and preventive actions, considerable investment, and changes in existing systems throughout a specific department or an entire pharma manufacturing facility.

Investigation

CAPA enables a pharma organization to investigate problems by utilizing the information collected. The CAPA includes the detailed study of information gathered by personnel with expertise in their field and applying different methodologies, tools, and thought processes. It enables investigators to understand complex systems and connect all the dots. 

Without a proper CAPA, the investigation lacks the following attributes

● Irregular investigative cycle, i.e. for an incident, sometimes an investigation is conducted, while for other incident investigation is completely neglected.

● Difficult to understand real-world problems being faced a pharma organization, and at the same time total failure to understand complex systems for accurate reasoning and evolvement.

● Failure or inability to allocate dedicated resources such as personal and tools, resulting in wasting them

The shortcomings mentioned above, and like these, can affect the investigation process, which ultimately involves preventive actions.

Resultant actions

The CAPA allows the pharmaceutical organization to take accurate corrective and preventive actions based on the data obtained and the investigation performed. It also devises different mechanisms to monitor the resultant actions and ensure that a thorough follow-up u1p appropriately implements the actions.

It is difficult to suggest the resultant actions if investigative data is unavailable.

Documentation

One requirement of CAPA is that the activity must be documented and presented to regulatory regulations. It enables a pharma organization to enter all the minute details of the activity, such as problems, causes, and actions.

Additionally, documentation helps pharma organizations keep historical trends of the problems and their respective corrective and preventive actions for future reference.

With an effective CAPA system, it is easier to keep records of the historical problems suffered by-products and processes, as it lacks a common format and system. It also becomes difficult to collect and retain data on a regular basis. 

CAPA as a part of the quality system

Quality System in the pharma industry is a critical requirement and is a part of the continual improvement of process, performance, and product quality according to the ICH Q10 guidelines. Corrective Action and Preventive Action are integral parts of the quality system, which aims to enhance quality in the pharmaceutical life cycle by detecting and resolving problems as they are discovered. 

Quality system elements describe the requirement of CAPA as follows. 

● Pharma companies should have an appropriate system for implementing Corrective Actions and Preventive actions obtained through detailed investigation of different pharma components such as complaints, product rejections, audits, recalls, feedback, and regulatory inspections

● The CAPA should be applied to find the problem's root cause, rather than just data collection.

● In performing the activity, the CAPA should follow the level of risk mentioned in ICH Q9.

● The entire activity should focus on product and process improvement and enhance the understanding of product and process.

Application of CAPA in pharma environment

The CAPA is effective and useful in the entire pharma product life cycle and can be used to evaluate risk and devise corrective and preventive actions. 

Let's look at the application of CAPA in the pharma industry according to the quality system.

Pharmaceutical development

Pharmaceutical development involves designing and developing a new drug product in response to various factors such as market demand, the effectiveness of previous drugs, and improvement in existing products. The major goal of pharma development activities is to deliver the required therapeutic effects consistently and, at the same time, meet end-user requirements.

Pharma development companies Can use CAPA to detect and investigate variability in products and the resultant corrective and preventive actions to improve the Pharma drug development process.

Technology transfer

Technology transfer is the transfer of knowledge for development purposes. It can be between the development and manufacturing stages or between different facilities in manufacturing control, validation, and continual improvement. 

CAPA in a technology transfer environment can be used as feedback for system improvement and to remove discrepancies.

Commercial manufacturing

When the product is finally developed, it is shifted to the manufacturing stage for commercial production. In this stage, the pharmaceutical organization has to follow pre-developed manufacturing and quality procedures without making any amendments.

CAPA in commercial manufacturing is used to verify the existing process and detect any anomalies in the manufacturing of the developed product. It allows us to evaluate risk, implement any preventive or corrective actions to prevent affecting product characteristics and produce the product with desired quality attributes and design requirements in the development stage.

Product Discontinuation

Product discontinuation is a critical process in the pharma industry, where a pharma manufacturer no longer produces and manufactures a product for many reasons, and now it is subject to shutdown. Product dis-continuation involves several steps: document retention, samples, and reporting to regulatory bodies.

CAPA for product discontinuation helps solve problems and regulatory irregularities, which could become problems for an organization. The CAPA is implemented for the discontinued product and focuses on critical factors such as completely removing the product from the market, document retention, and remanufacturing to asses risk and execute any corrective and preventive actions.

CAPA format

The CAPA activity is recorded in an approved format that contains all the information collected during the activity. It can take any form but should include all relevant information, such as 

● Problem statement

● Department

● Risk level

● Propose corrective action and its due date

● Proposed preventive action and its due date

● Next review data

● Details of the personnel performing the CAPA

● Authorized signatures

How to perform CAPA in a pharma environment

There can be many steps in performing CAPA in a pharma organization, which mainly depends upon the type of problem and area of interest. A typical CAPA can include the following steps.

● Identify the problem or the risk. Review risks that could impact a particular pharma process and how they impact it. 

● Assess the identified risk or problem and categorize it into relevant categories according to the organization's policies.

● After assessment, propose relevant corrective actions to solve the problem in the initial stage. Also, describe the deadline for the implementation of disciplinary actions. 

● After implementing corrective actions, devise preventive actions to prevent the problem from occurring in the future. The timeline for proposing preventive action should also be mentioned.

● After implementing corrective and preventive actions, record all these measures to validate the effectiveness of the proposed measures. Document the entire activity in an approved format, recording all parameters such as proposed actions, date of implementation, deadline, and the result of the CAPA activity.

About the Author:

Muhammad Asim Niazi

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.