STANDARD OPERATING PROCEDURE HANDLING OF DEVIATION

STANDARD OPERATING PROCEDURE

SUBJECT:                      HANDLING OF DEVIATION

DEPARTMENT         : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To lay down a procedure for Handling of Deviations in test method and production related processes and this policy is applicable to all products.

2.0       POLICY:    

Applicable for handling of process and system deviations

3.0       PROCEDURE:

3.1       Generally NO DEVIATION is allowed in testing RM, PM, In-process, Finished materials analysis.

3.2       The initiating department office shall raise the proposal of deviation form.

3.3       The fully filled deviation form shall be send to department head for further evaluation, format included in Annexure-1.

3.4       The department head or his designee of the initiating department shall review the form, and the form shall be marked as Approved or rejected. If any information required, the form may be sent back to the initiator for further details.

3.5       If deviations related to changes in manufacturing and packing that may impact the registrations   

for the product then it is to be intimated to the Drug Control Administration.

3.6       The QA In charge should take the opinions of all other departments and re-evaluate it.

3.7       Approved proposal of one copy shall be forwarded to initiating department and original should be documented in Quality Assurance.

3.8       If the deviation is planned for a particular batch, it is to be ensuring that the action committed shall not be extended beyond the batch.

3.9       Completed & closed reports shall be filed with documentation Assurance. All deviations need to be notified to customers/principal Company representative.

3.10     A review of deviations shall be carried out on Annual basis.

3.11     In case of any alteration required in the methods for the above mentioned, the altered method must be validated and should have the approval of the principal.

3.12     The revised method of testing must be justified and all results are documented and sent to the parent company.

3.13     Corrective actions will be taken by the Parent company

3.14     The revised method of testing should be precise, rugged and stability indicating.       

4.0       FREQUENCY: As and when required.         

5.0       RESPONSIBILITY

1.0            REVIEW GUIDE:  Deviation file

7.0        ANNEXURE: 1.Deviation report.

8.0        SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	√
Warehouse	x	x
General	x	x
Maintenance	x	x