MODUL E-LEARNING SMART CDOB || PENYUSUNAN CAPA SERTIFIKASI CDOB

Summary

This video explains the process of compiling Corrective and Preventive Actions (CAPA) for drug distribution certification (CDOB). It highlights the importance of addressing root causes for non-conformities and implementing effective corrective and preventive steps. The video outlines a CAPA matrix and provides an example related to drug mutation findings. It also explains the steps for inputting CAPA data into the CDOB certification application, emphasizing the importance of timely submission within 40 working days. Assistance services such as consultations and Deskapa are available to support PBFs in fulfilling the requirements.

Takeaways

• 😀 Corrective actions (CAPA) are steps taken to address problems that have already occurred, while preventive actions are proactive steps to prevent future issues.
• 😀 CAPA is an essential process for ensuring compliance with drug distribution certification (CDOB).
• 😀 The key elements for effective CAPA implementation include overcoming non-conformities, adhering to agreements, and ensuring the actions can be implemented within available resources.
• 😀 A CAPA matrix is used to document each step in the process, ensuring clarity and structure.
• 😀 An example of a CAPA finding involves improperly recorded drug mutation details like batch numbers and expiry dates on stock cards.
• 😀 The root cause for the issue in the example was a lack of SOP (Standard Operating Procedure) details on batch numbers and expiry dates, as well as insufficient SOP training for warehouse officers.
• 😀 Corrective actions for the example include proper recording of drug mutation information and revising the SOP to include necessary details.
• 😀 Preventive actions include socializing the revised SOP with all relevant officers to ensure uniform compliance.
• 😀 The CDOB certification platform allows users to input CAPA details, track progress, and manage findings within the system.
• 😀 The maximum time for fulfilling CAPA is 40 working days, with two opportunities to meet the deadline. Failure to do so results in rejection and requires resubmission.
• 😀 Desk consultations (Des KAPA) are offered to assist with the CAPA process, both offline and online, to ensure timely and compliant completion of the CAPA requirements.

Q & A

What does CAPA stand for in the context of CDOB certification?

CAPA stands for Corrective Actions and Preventive Actions. Corrective Actions address problems that have already occurred, while Preventive Actions are proactive steps to prevent similar problems from happening in the future.

What are the key steps in compiling CAPA after an inspection?

The key steps in compiling CAPA after an inspection include identifying non-conformities and the root cause, following applicable requirements and provisions, ensuring the actions are feasible, and implementing them effectively within the available resources.

Why is it important to address the root cause in the CAPA process?

Addressing the root cause is crucial because it ensures that the underlying issue is resolved, preventing the same problem from recurring. It helps create long-term solutions rather than just temporary fixes.

Can CAPA be implemented without the required resources?

No, CAPA must be compiled according to the available resources and capabilities. Implementing actions that are feasible and resource-appropriate is essential for success.

What example of a CAPA issue was provided in the video?

The example provided in the video was related to drug mutations not being recorded in an orderly manner on stock cards, specifically regarding the batch numbers and expiration dates.

What were the root causes identified for the drug mutation recording issue?

The root causes included the SOP not specifying the recording of batch numbers and expiration dates, and the fact that not all warehouse officers had received the necessary SOP socialization.

What corrective actions were recommended for the drug mutation recording issue?

The recommended corrective actions included recording drug mutations with batch numbers and expiration dates in an orderly manner, revising the SOP to include these details, and training relevant officers on the updated SOP.

How do you submit CAPA requests through the CDOB certification application?

To submit CAPA requests, log in to the CDOB certification application, select the CAPA request folder, fill in the necessary details such as the root cause and corrective actions, and attach supporting files. Ensure the information is accurate before submitting.

What is the time limit for fulfilling CAPA requirements, and what happens if it is exceeded?

The time limit for fulfilling CAPA requirements is 40 working days. If the CAPA is not fulfilled within this time frame, the application will be automatically rejected, and the PBF will need to resubmit.

What assistance is available for organizations struggling with the CAPA fulfillment process?

For organizations facing difficulties with the CAPA fulfillment process, Deskapa services are available. These services can be conducted online or offline and provide guidance to ensure CAPA is completed on time and according to regulations.