DOCTOR PACK INDIA PVT LTD CUSTOMER COMPLAINT INVESTIGATION REPORT

FM-QA-044 Rev No:00 Effective date:01.06.2011 Next Rev.date: 31.05.2013 Page 1 of 2

CC Investigation Number : 04/2011 Date of Initiation of Investiga tion: 08/10/2011 Product / Material: Compliant Description: Batch No. Product Description Due date for Investigation closure: 09/10/2011

5 ml Bottle N Design White (B.No.011) Qty: 100K Mix up of product 15 ml TR Design bottle(B 037)found instead of 5 ml N Design Bottle Complaint Observed Rate

B011

DC No./ Invoice No./ COA No. N Bottle In.#148 white dated 15th July 2011 Qty: 100K

15 ml TR Design bottle(B 037)found Major instead of 5 ml N Design Bottle Noticed by Customer in two cartons. In C.No.2073: All the bags were 15ml TR bottles In C.No.:2064 Out of six two were 15ml of TR Bottles.

Summary of the Failure: No such mix-ups incident reported in the Batch records of the both the lots. While investigating the newly inducted trainee in OQC, he was handled the inspections of both the lots at a time and thereby might have chances of mix-ups. Inspection by QC:Ganesh Sign & Date Supervisor / Head- QA: Balaji Sign & Date

Were there any obvious reasons for the compliant identified? YES / NO If YES, elaborate with proposed action: If NO, elaborate proposed action: 1. Line clearance procedure should be tightened. Photograph to be taken while approving line clearance. 2. Current approval procedure to be revised, Production Manager, QC Asst. Manager, QA Manager should ensure & approve the line clearance as per the new procedure. 3. Material handling to be done in a cotrolled way. ie at a time one has to handle/move one type of product only. 4. In Contract review , production /OQC personnel are also to be engaged. Findings and observations from above action: As above

DOCTOR PACK INDIA PVT LTD CUSTOMER COMPLAINT INVESTIGATION REPORT

FM-QA-044 Rev No:00 Effective date: Next Rev.date: Page 2 of 2

Corrective Action / QA recommendation : Recall all the mix-up cartons (about 6000) from the customer and replace the same qty with the same batch on or before 20th OCT 2011. OQC Inspector is given awareness training on GMP & Pre- Dispatch Inspection.

Conclusion: Recall the above said quantity Bottles from the customer and replace with current approved batch from production.

Head QA PREVENTIVE ACTION

Date:

1. Reconciliation is planned during Despatch with material management application domain. 2. At a time one product to be handled. 3. GMP awareness Re-training is planned. 4. Maintaining the production plan, not to overlap any similar variant at a time. 5. Involving all the process stakeholder in the Contract review process so as to understand very well the customer requirements.

Head QA:

Date:

ANNEXURE: TRAINING RECORD