sop of general Non-Conformance incidence

1.0. OBJECTIVE:

The objective of this SOP is:
1.1 To describe a procedure for handling of any observation of general Non-Conformance incidence.

2.0. RESPONSIBILITY:

2.1 Head of the Concerned Department / In-Process QA Personnel shall be:
2.1.1. Responsible for intimating the non-Conformance incidents to Quality Assurance through General Non-Conformance Report. .
2.2 Quality Assurance shall be:
2.2.1 Responsible for investigating and approving the process deviation report.
2.2.2 Responsible for Recommending and corrective actions to concerned department.

3.0. ACCOUNTABILITY:

Head – Quality Assurance

4.0. PROCEDURE:

4.1 Any abnormal finding or deviation from Standard Operating Procedure (SOP) other than those related

to batch manufacturing procedure shall be considered as an incidence of general Non- Conformance nature.
4.2 No general Non-Conformance incidence shall be permitted under normal operating conditions however, in case the general Non-

Conformance incidence is observed anywhere in the plant the concerned Department shall the immediate corrective action.
4.3 Such an incidence or observation shall be brought to the notice of Quality Assurance Head by the Head of concerned

Department / IPQA personnel through General Non-conformance Report as per Annexure – 1.
4.4 Each general Non-Conformance incidence report shall be numbered by the initiating Department in the following manner.

4.5 The number shall comprise of 4 characters.
4.6 The first character shall be an alphabet representing the originating Department as listed below:
Production General Block ‘A’
Production Cephalosporin Block ‘C’
Engineering ‘E’
Information Technology ‘I’
Purchase ‘P’
Materials ‘M’
Quality Assurance ‘Q’
Ware house ‘W’

4.7 The next 3 Character shall be a digit serial number starting from ‘001’.
4.8 Quality Assurance Head shall evaluate the observation of general Non-Conformance incidence for

its impact on product identity, strength, quality and purity.
4.9 After review Head – Quality Assurance shall give his recommendation, which may include steps to avoid such

incidence / deviation in future and additional testing of the product involved if required.
4.10 Original copy of the General Non-Conformance report shall be retained by Quality Assurance and one

photocopy shall be issued to Concerned Department.

5.0. REASON FOR REVISION:

This SOP is revised due to revision due date.

6.0. TRAINING:

Trainer — Head – Quality Assurance
Trainee — All departmental heads / Quality Assurance Personnel
Period — One day

7.0. DISTRIBUTION:

Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 2 : Head of Department – Cephalosporin -Block
Certified Copy No. 3 : Head of Department – General – Block
Certified Copy No. 4 : Head of Department – Warehouse
Certified Copy No. 5 : Head of Department – Engineering
Certified Copy No. 6 : Head of Department – Purchase
Certified Copy No. 7 : Head of Department – Materials
Certified Copy No. 8 : Head of Department – Information Technology
Original Copy : Head – QUALITY ASSURANCE

8.0. ANNEXURE:

Annexure – 1 : Format for General Non-Conformance Report.

9.0. REFERENCE:

In-house