Follow
1. As much as possible there should be no deviation in the manufacturing or packing process.
2. Deviation can be planned and unplanned If there is any deviation it should be classified as minor or major deviation.
3. In case of minor deviations in the production process which do not affect the final parameters of the product or its quality or durability. Deviation should be approved by Production Manager and Q.A. department and they simply perform the process.
4. Minor batch deviations (including approvals) should be limited to the specified batch only so that the batch can be completed.
5. After minor deviation, if the product specification is changed, the changes should be recorded / regularized / and approved by the Technical Director.
6. In case of major deviation in Mfg./Pkg. Process such as (i) any change in RM or its supplier and quantity per batch; (ii) any change in the primary packing material or its supplier.
7. The change should be valid for three consecutive batches.
8. The change should be studied for stability purposes. Party stability in case of loan license will be managed by the concerned party.
9. The change should be approved by Technical Director or Q.A based on data from validation and stability studies. Manager before implementing it in regular batch.
10. A detailed report on investigation and deviation will be prepared and kept on file for further reference.
Procedures for raising deviation reports
1. The request for deviation shall be raised by the manager of the concerned department. in the approved format with justification of deviations.
2. The Chief Technical Director of the location will comment on the deviation.
3. Comments of the Regulatory and Product Development Division. Whether the validity is done. Stability study is required for change control or not.
4. Decision regarding approval/sanction of deviation shall be taken by Q.A. Manager in case of loan license party or Technical Director in case of Promed products.
5. Closer comments will be made by referring to B.No. & Completion Date.
