Way to Improve Investigation Report in Pharmaceuticals: It becomes very important for organizations to write an investigation report while getting any observations during routine audits or external audits. As before FDA had issued more than a hundred of 483 observations during the last few years.
The organization gets a chance to comply with the observation to get out of this trouble, it becomes the responsibility of manufacturers to write an effective investigation report.
What is an Investigation Report
An investigation Report is prepared while getting a deviation. Deviation occurs while not following standard test procedures, and SOPs during the manufacturing and packing of the products. the main purpose of investing report the identify the problems by the root causes investigation or either by investigation step by step to improve the quality, purity, efficacy, and safety of the product.
What does FDA Expect?
FDA mainly looks for an investigative approach to complaints, Deviation, OOS, EM data (investigate alert and action excursions), and aberrant peaks.
Define the scope: Has the same accident happened before, are the same product batches affected, other processes, and others products?
Conduct the Risk Assessment: Risk assessment is required as per ICH-Q9, and focuses on the patient impact.
Root causes: FDA expects an effective root cause, Organization provides the data if makes any claim, and proves it by attaching evidence. Re-training is often necessary, but not sufficient.
CAPA: make sure CAPA is linked to the root cause. if you have past CAPA failure don’t repeat the Previous Corrective and Preventive Action.
Check the effective measurements, what will you measure, when will you measure, and what is accepted standard is.
Elements for how communicating your expectations
- Problem statement:
- Clear: The statement should be short, accurate, and easy to understand.
- Who: Just write who was involved, don’t blame any
- What: Described the requirement or specification that was not met
- When: mention dates with time, when occurred, when identified.
- Where: where the process occurs, equipment, location and define steps involve during the process.
- Gives facts, not speculate
- Don’t fall into the root cause, it starts after conducting the investigation.
- Scope: While looking for a scop considered the 5 main points
- How big are the problems?
- Are other baches affected?
If anything is out of scope, Describe them well along with justification.
2. Risk Assessment:
Calculate the overall risk of patient impact at Low, Medium, and High for the detection, frequency, and severity. Risk assessment to be done as per ICH Guidelines Q9.
3. Root cause Analysis:
- Use the appropriate tool, and logical approach to identify potential root causes.
- Explain what you explored and how you reach a final conclusion.
- Linking Root cause with corrective and preventive actions.
4. Analyzing Data:
- Track the event through TracWise, at the same site (or another site) if a previous event occurs then use the analysis tools to explore the data by using any chart and table.
- Identify and isolate the data as per vendor, shift, trends pattern, and machine. when did the problem happens or start?
5. Effectiveness check or Rebust the CAPA:
Will CAPA is going to effective if tied with the root cause
Considered three important things: What will you measure, When will you measure, and What are the acceptance standards?
Note: In rare cases, immediate corrective actions taken at the start of the investigation will be enough, at that time no additional action is required. in this case, only provide a statement within the investigation report that no additional actions are needed.
Includes the Reviewers and Approvers. Distribute the copy of feedback to reviewers and approvers so that they can examine it.
Impart Training on root cause at every site