Details for Deviation No.______________
Department : Production
Investigation starts date:
Investigation completion date:
|4.||QA Officer||Quality Assurance|
|5.||QA Head||Quality Assurance|
|Product||Batch No.||BMR Reference Number
|1||Pioglitazone 30 mg tablets||BMR__________|
Details of Deviation:
Final batch yield was found 83.81 % which is less than the limit (85% – 100).
Details of investigation of Deviation:
The investigation team investigated root cause of the problem in the following aspect:
- Review of BMR from dispensing stage to inspection stage for identification of any type of non-compliance in previous stages of manufacturing:
- Verify all API and raw material dispensed quantity, approval of material, API calculations, and labels of API and excipients, that are attached in the BMR, and counseling the person that was involved in the dispensing of the batch, it was found that dispensing activity was done properly and as per the defined procedure.
- Granulation stage was verified and it was found that all the activities are done properly as per equipment operational SOPs and as per BMR instructions. The yield of the granulation stage was verified and found to be 99.58% (limits 97% – 100%). No non-compliance was observed.
- In compression stage machine setting parameters, the in-process tests of tablets, done by Production and QA were verified, and it was found that all the in-process tests results are complying with the specifications. Also, the batch yield of the compression stage was verified and it was found within the limit – 98.75% (limits 90% – 100%).
- During the inspection, 3.20 kg of tablets were found with rough surface by visual inspector and these tablets are segregated.
- All the segregated rough surface tablets were quarantined and Hold label was put on them, and they were left waiting for QA Head decision
- Final decision taken by QA Head – these tablets are not to be used for next process and these tables to be rejected and treated as “Non-recoverable”.
- All the recoverable quantity to be recorded in the BMR.
Root cause of deviation is the following – the batch yield is less because3.20 kg of rough surface tablets were rejected.
During a thorough investigation of the deviation for identification of the actual root cause the batch yield is less because 3.20 kg of rough surface tablets were rejected, we found that the batch was manufactured as per approved procedure. The product was manufactured, packed and tested as per standard procedure and there is no quality impact of this deviation on product.
List of Annexures:
|S.No||Name of the Annexure||Annexure No.|
Investigation Report Approval Details:
|Checked & reviewed by|
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