CAPA is an important Quality tool in the pharmaceutical industry. CAPA is defined as the corrective action and the preventive action. “A corrective action is a change implemented to address a weakness identified in a management system” whereas the preventive action is “The action to eliminate the cause of a potential nonconformity or other undesirable potential situation”. Management plays a key role in the successful implementation of the CAPA system for achieving the high quality pharmaceutical products. It helps the management to identify the problem that arises in the system and helps the administration to come up with the innovative ideas to improve the quality of the product.This Document discusses the Obstacles for achieving the integrated CAPA compliance, quality system CAPA procedure, Flow chart for implementing the CAPA system, phases of the CAPA system, benefits of the CAPA system ..
In this stage of the CAPA process there must be the problem that has been identified, defined and documented. The documentation should completely explain about how the information has been gathered and it also should have the proof for the existing problem.
In the appraisal stage the quality personnel member of the CAPA case will need to determine the impact of the quality on the company’s overall quality management system which include cost, function, safety, quality etc.. The determination regarding impact should include the risk to the customers as well as risk to the employers. Once the impact and the risks are identified then the seriousness is determined. Based upon the companies’ long term experience the companies will associate the varying degree of the seriousness based upon which the necessary corrective and preventive actions will be taken.
If you need assistance with writing your essay, our professional essay writing service is here to help!Essay Writing Service
Phase-3 discovery phase commences only when the remedial action does not solve the problem during phase-2 or when a long term action is required then the phase-3 action commences. Discovery phase is also called as the investigation phase and before the investigation commences specific goals are set in a manner such that these goals are accomplished before the phase-6.For accomplishing these goals specific strategy is developed which includes specific strategy for determining the contributing and root cause of the problem. It also include all specific circumstances related to the problem which include training, software, external factors, procedures, personnel, materials and equipment.
During the examination phase rooting out of the problem takes place after determining the possible and probable causes of the problem and data has been collected to refute these problems. The data that has been collected during this stage has been organized and documented .The sources for the examination phase can be from the testing results and review of the records, processes, service information, design control, operations which helps in determining the root cause of the problem. All the information is collected, organized and documented in readable form.
ACTION AND IMPELMENTATION:-
During this phase the REAL LIFE of the CAPA takes place. In this stage the investigator has to determine the root cause of the problem and he or she has to develop the methodology that prevents the problem to occur further. All the incidents in this stage are documented and for the successful implementation of this stage a successful CAPA SOFTWARE has been introduced which not only save the time and money but also keeps the records for the long term usage for tracking how the problem has been resolved.
OBSTACLES FOR ACHEVING INTEGRATED CAPA COMPLIANCE:-
CAPA management is an important part of the regulatory requirement which helps in reducing the liability, increases the customer satisfaction, helps in the reduction of the financial losses and strengthens the company’s reputation. To achieve the maximum benefits from the CAPA, it must be an integral part of the enterprise compliance and quality management system(ECQM) which helps in the collection of the data on the existing problem, investigators will analyze the potential data, digs out the root cause of the problem, addresses the issues and follows the procedures to avoid the similar problem in the future and documents the entire process.
CAPA can be effective only when it is an integral part of the company’s culture. However they were many obstacles which prevents for achieving a truly integrated quality management system. Among those are the
CAPA compliance is included in company’s standard operating procedures however it is difficult to achieve the process with systems that most companies have. They are different programs that don’t interface with each other, homegrown systems that don’t have universal recognition, delaying the resolution of the quality issues and clouding the compliance picture.
Companies should require the centralized control without which the documentation chain required by the regulatory agencies is frequently broken. Companies should document their CAPA procedures without which the FDA will not know the CAPA requirements have been fulfilled.
3-COMMUNICATION BARRIERS BETWEEN CULTURES AND SPECILATIES:-
Employees working in the company don’t speak the same language, literally. In addition the terms that an engineer uses to describe a quality system may be different from that marketing manager or the compliance officer.
4-LACK OF TRAINING:-
Majority of the employees that are working in the compliance issues are not well trained.so the Employees who are working in the quality management do not know, understand and take the responsibility as their role as the quality management.
5-DISCONNECT AMONG BUSINESS UNITS:-
CAPA management is frequently seen as a job for the quality management but not as a concern in which production, R&D, marketing or other departments which should be involved.
6-NON COLLECTION OF TRENDING DATA OR DATA NOT READILY AVAILABLE TO APPROPRIATE PERSONNEL:-
Without the integrated ECQM, most departments keep the records on their own systems without which the company management cannot see the Companies compliance picture. Without this vision, the management cannot predict and prevent possible deficiency to meet the CAPA regulations.
7-SEEKING A QUICK FIX VERSUS SEEKING TO CORRECT THE ROOT CAUSE:-
Companies generally focus on the product and the material issues rather than reaching below the surface to identify and address quality concerns. It results on focusing on product problems rather than on the systemic issues which prevents them to correct a root problem. However getting to the root cause is main aim of the CAPA.
TRUE CAPA implementation is to identify and correct the problem by putting practices to prevent the future issues which require the integration and flow of information freely among companies various departments and locations.
Five steps for success of CAPA system:-
1. Companies should implement an effective quality management system for tracking and logging the events utilizing centralized software system which helps in determining the root cause and implement an effective CAPA system. Moreover it also helps in the reduction on the boundaries between various departments.
2. Companies should implement an effective comprehensive investigation and root cause analysis which helps in developing the effective corrective and preventive action.
3. Accountability is maintained through notification and escalation procedures by utilizing the automated and the on the demand reporting. Communication helps in the resolution of the events in the timely manner whereas notification helps the management know where exactly the record is in and who is working on it. Notifications are approved to key personnel via record origination, record assignment, task completion and record approval. An escalation procedure helps in ensuring the key personnel about the dates approach and priority management responsible tool to the particular parties.
4. Easy accessibility of the Records, Notification and reports helps all the key personnel in the immediate response of the resolution process. Web based system also helps in to log in into QUALITY MANAGEMENT SYSTEM from any location which helps in quick response.
5. Effective checks are conducted to measure how well the CAPA plan worked Post implementation. A well-defined planning is essential for the elimination of the recurring events. This system helps in creating and assigning the effectiveness of the check records for each CAPA plan. If the issue is resolved, a review is conducted in the final stage.
Phases of CAPA system:-
CAPA system plays an important role in the quality management system. CAPA consists of the four important phases..
Planning for the Measurement, Analysis and Improvement Process
Establish the Data Sources and the Criteria
Measurement and Analysis
Measurement and Analysis
Identify the Action
Identify the Root Cause
Verification Of identified Action
Determine Effectiveness of Implemented Action
Reporting to Management
Phase – 4
Sample CAPA Process Flow
Corrective Action Request
No Action Needed
Root cause analysis and Corrective Action
Requirements of Corrective and Preventive action (21 CFR 820, Subpart J)
(1) For the corrective and preventive action, manufacturer should create and maintain the procedure and this procedure include some requirements for:-
a) Service record complaints, Audit report of quality, records of quality, and operations of work, quality data sources to justify the obtainable and possible cause of original product. For detection of returning quality problems, this type of statistical methodology should be employed
b) For the product, processes, and the system of quality, consider the cause of non-fulfillment of requirement.
c) For the reappearance of unusual product and problem related to quality, recognize the corrective and preventive action.
d) To decide the recognized corrective and preventive action is successful and has no adverse effect on finished devices; validate that corrective and preventive action.
e) For correct and prevent recognized problem of quality it is necessary to implementing and recording the changes in method and procedure.
f) Decide that information which are related to the problem of quality which is circulated and directly responsible to give surety such product quality for avoid of such problem.
g) For review of Management, submit the corrective and preventive action and information of recognized problem of quality.
(2) All actions necessary under this section, and their results should be documented
Benefits and futures of CAPA
(Fig -1- Benefits and Future of CAPA)
1.COST EFFECTIVE:-Many organizations do not implement a robust CAPA process because of its high cost.so CAPA is tracked by simple spreadsheets and home grown database which do not require full CAPA requirements. Where as Ready CAPA provides an application to meet quality management at an affordable price.
2. COMPLETE VALIDATION PACKAGE:-It is the part of the READY CAPA which ensures that the application is ready to use in days versus weeks
3. WORK FLOW APPROACH:-READY-CAPA enables to know that issues are tracked completely to resolution. CAPA helps in deciding the issues related to the problem and helps in solving and easily documented. It also helps in deciding the progress of the CAPA.
4.REGULATORY COMPLIANCE:-The procedures and policies followed by the companies must meet the regulatory compliance which includes the identification of the interphase system, constructed and tested the documents and policies and procedures.
5.CLOSED LOOP CAPA PROCESS:-It is implemented by the Ready CAPA electronic work flow. This helps in identifying the issues ,investigating the cause, action planning for the corrective and preventive action, implementing the actions, verifying the quality assurance approval, monitoring the periodic challenge option and closing
6. Closed loop CAPA helps to reduce the loss of data.
7. Closed loop CAPA management helps in providing the controlled environment.
8. CAPA helps in increasing the product quality by reducing the product cost and cycle time.
Now a days Quality has become an important issue in the pharmaceutical Industry. CAPA plays an important role in achieving the high quality of the pharmaceutical products. Many pharmaceutical companies are implementing the CAPA system which helps in reduction of the cost as well as improve the quality of the product. For the successful implementation of the CAPA, there should be a well-trained knowledgeable operator. The main aim of the CAPA is to identify the Root Cause of the problem and provide a solution to the problem that does not occur repetitively. Manufacturers when implementing the corrective and preventive actions must comply with the ISO standards for achieving the high quality. Management plays a key role in the successful implementation of the CAPA in the company for achieving the high quality of the product. Thus this document provides the guidance for the successful implementation of the CAPA.
Cite This Work
To export a reference to this article please select a referencing stye below:
Related ServicesView all
DMCA / Removal Request
If you are the original writer of this essay and no longer wish to have your work published on UKEssays.com then please: