Un-Planned Deviation – II in Pharma
Details for Deviation No. ________
Department : Production
Investigation start date :
Investigation completion date:
|5.||QA Head||Quality Assurance|
|Sr.No.||Product||Batch No.||BMR Reference Number|
|1||Ambroxol HCL tablets 75mg||BMR_____________|
Details of Deviation:
During the in-process test of IPQA at compression stage IPQA observed some broken tablets from left side of the compression machine and 5.59 kg of tablets were rejected by QA and due to this the compression stage batch yield is 90.05%, which is less than standard yield limit (96-100%).
Immediate action taken by QA:
- IPQA immediately stopped the machine and isolated the container and labeled it “Hold”. IPQAalsoinformedQAHeadimmediately.
Investigation summary with probable root cause:
The investigation started considering associated risk analysis by using Cause and Effect analysis tool (i.e. Ishikawa/fish-bone Diagram) and the complete details are listed below:
|Man||In said batch, we are verifying associate risk considering above mentioned cause of fishbone diagram with respect to man and found that all process-related documents were clearly disseminated to personnel (instruction of machines, manufacturing procedures, precautions to be taken during manufacturing).SOPs of respective equipment like Operating and cleaning procedure for the machines are in place.
The personnel who performed the activities were well trained and skilled.
Sufficient personnel were there when the batch-processed, there was no shortage of personnel.
After complete investigation of the batch with respect to personnel, it was concluded that all the personnel involved in manufacturing of the batch were fully trained and no root cause observed related to man.
|Machine / Оборудование||In said batch, we are verifying associate risk considering above mentioned cause of fishbone diagram with respect to machine and found that correct equipment was used and equipment was properly maintained as per preventive maintenance schedule and complies with product requirements.
It was found that compression machine scrapper of gravity feeder at the ejection point was not properly adjusted and due to this the problem happened and no root cause observed related to machine.
|In said batch, we are verifying associate risk considering above mentioned cause of fishbone diagram with respect to method and found that working instructions regarding this procedure are clearly written and available.
In BMR all procedures regarding manufacturing are well defined, so there is no chance of negligence.
The QC results of blend stage are complying with the approved specifications.
No deviation observed and recorded during dispensing, granulation of batch.
All stage entries signed and authorized by designated personnel.
All stages of the manufacturing process were reviewed and found to comply with predetermined specifications.
After complete investigation of the batch with respect to method, it is concluded that all the methods used in manufacturing of batch were correct and logical and no root cause observed.
|1) In said batch, we are verifying associate risk considering above mentioned cause of fishbone diagram with respect to material and found that API and excipient were issued as per Raw material issue note; the calculation of the API was done correctly.
Handling procedures for all materials during manufacturing were verified and found to be satisfactory and no sign of discrepancy observed.
After complete investigation of the batch with respect to material, it is concluded that all the materials used in manufacturing of the batch were correct and no root cause observed during manufacturing process.
After a thorough and deep investigation for root cause analysis on different aspects using Fish–Bone diagram, no discrepancies were found in manufacturing process.The deviation occurred due to improper adjustment of the scrapper of gravity feeder at the ejection point.
Corrective Action and Preventive Action:
- Quarantine all the containers from previous IPQA in-process test.
- IPQA withdrew samples from various positions from each container from previous in-process test, performed the in-process testing for all physical parameters, visual check for broken tablets, and found that all the samples of previous container meet the acceptance limit except current container had the broken tablets. Remaining containers had no broken tablets.
- IPQA also verified all remains compressed tablets and will do random sampling from all other remains containers and performed the in-process testing for all physical parameters, found that all the samples of the previous container meet the acceptance limit.
- After the proper adjustment of scrapper of gravity feeder at the ejection point and IPQA verified the in-process testing for all physical parameters of again compressed tablets sample and after satisfactory result, the compression was allowed to continue.
- As per QA head the instruction, manual inspection was performed the last container. After inspection 5.59 kg of tablets were found breakage defect, all these tablets quarantined and remains good tablets were again performing the in-process testing for all physical parameters by IPQA and after satisfactory result, they allowed for the next process.
- The remaining tablets during an inspection from the under-hold container will be kept as “Non-recoverable”
- All the recoverable quantity record in the BMR.
- Training to be conducted to all concern personnel.
During a thorough investigation of the deviation for identification of the actual root cause of failure with respect to Man, Material, Machine and Method, we found that the batch was manufactured as per approved procedure. All the personnel that were engaged in the manufacturing process were properly trained and no non-conformances were observed during the whole process. It can be concluded that the deviation occurred due to improper adjustment of the scrapper of gravity feeder at the ejection point and the training was given to the operator and production technologist to prevent such kind of mistakes in future.
List of Annexures:
|S.No||Name of the Annexure||Annexure No.|
Investigation Report Approval Details:
|Done By||Checked By||Approved By|
|Name/ Sign||Name/ Sign||Name/ Sign|
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube