NSQ Drug: Route cause analysis and CAPA

These actions should be designed to address the root cause of the problem and prevent it from happening again in the future.

Rakesh Dahiya

February 2, 2023

1008

NSQ Drugs Substandard drugs Fail samples NSQ Samples Substandard samples — NSQ Drugs

Table of Contents

Author
Recent Posts

Rakesh Dahiya

SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com

Route cause analysis (RCA)

Route cause analysis (RCA) of a drug is a process used to identify the root cause of a problem or deviation that occurred during:

Manufacturing,
Testing,
Packaging,
Distribution of a drug.

The goal of RCA is to identify the underlying cause of the problem so that corrective and preventive actions (CAPA) can be implemented to prevent it from happening again in the future.

RCA process

The RCA process typically begins with the identification of a problem or deviation. This can be identified through a variety of means such as customer complaints, product testing, or internal audits.

Data collection

Once the problem has been identified, the next step is to gather data and information related to the problem.

This may include data from the records of:

Vender selection,
Raw material purchase,
Raw material specification,
Raw material testing record,
Packing material purchase,
Packing material specification,
Packing material testing record,

Validation of equipment,
Production records,
Standard manufacturing formula
Calibration of instruments,
Standard testing procedure
Finished goods testing record,
Self inspection records.

After the data has been collected, it is analyzed to identify potential causes of the problem. This can be done using a variety of tools and techniques such as:

Fishbone diagrams,
Pareto charts,
Cause-and-effect diagrams.

The analysis should identify the most likely cause of the problem, as well as any contributing factors.

Click for Guidance documents for industry

Corrective and preventive actions (CAPA)

Once the root cause of the problem has been identified, the next step is to develop and implement corrective and preventive actions (CAPA).

These actions should be designed to address the root cause of the problem and prevent it from happening again in the future.

CAPA procedure

CAPA may include changes to the manufacturing process, changes to the packaging or labeling of the product, or changes to the quality control procedures.

The effectiveness of the CAPA should be evaluated to ensure that it is effectively addressing the problem and that it does not create any new problems.

It is important to note that the RCA process is an ongoing effort and should be regularly reviewed and updated as necessary.

This will ensure that any new problems or deviations are identified and addressed in a timely manner.

Conclusion:

In conclusion, drug route cause analysis is an important tool for identifying and addressing problems that occur during the manufacturing, testing, packaging, and distribution of drugs.

By identifying the root cause of the problem and implementing corrective and preventive actions, manufacturers can ensure that their products are safe and effective for patients.

Must read

Guidance Articles for Industry

How to prepare SOPs in the Pharma Industry

Difference between branded and generic medicines

Understanding DQ, IQ, PQ, and OQ in the Pharma Industry

Duties and responsibilities of QA person in Pharma Industry

Types of Tablet Coating and its Functionality in pharma industry

Dissolution test: Importance in Pharma Industry

Lux level in Industry (Pharma, Cosmetics, Homeopathy & Medical Devices)

NSQ Drug: Route cause analysis and CAPA

Area required for manufacturing of Drugs, Cosmetics, Homoeopathic & Blood Centre

BA / BE Studies: Bioavailability & Bioequivalence