sop for Responsibilities of Quality Assurance
1.0 OBJECTIVE:
To lay down a Procedure to define Role and Responsibilities of Quality Assurance Department.
2.0 SCOPE:
This SOP is applicable to define the Role and Responsibilities of Quality Assurance Department
3.0 RESPONSIBILITY:
QA Officer/ Executive
4.0 ACCOUNTABILITY:
Head QA: Approval
5.0 PROCEDURE:
5.1 Responsibilities of Quality Assurance is given below:
5.1.1 To impart cGMP, GLP, Behavioral, Motivational and other kinds of Training ensuring Compliance of the specified
procedure/guidance’s.
5.1.2 Handling of Quality Management System, Including Change Controls, Deviations, Incidents, Control of Non-Conforming
Materials/Products, Monthly Reports, Analytical Method Validations, Analytical Method Transfers,
Vendor Audits and Updating the Approved Vendor List (s), OOS, OOT, CAPA, etc.
5.1.3 Co-ordination with various Departments to implement cGMP in Plant.
5.1.4 Destruction, Review, Approval and Rejection of Documents.
5.1.5 In-Process Control.
5.1.6 Handling of Rework & Reprocess.
5.1.7 Handling of Yield Variations.
5.1.8 Monitoring and Control of Manufacturing Environment.
5.1.9 Designing and Monitoring the Storage conditions for Materials and Products.
5.1.10 Monitoring of Utility like HVAC, Water System etc.
5.1.11 Training.
5.1.12 Documents Control.
5.1.13 Qualification and Validation Activities.
5.1.14 Handling of Validation Failure.
5.1.15 Vendor Audit/Approval.
5.1.16 Preparation, Handling and ensuring compliance of various Regulatory Agencies & Customer Audits.
5.1.17 Investigation and Collection of Samples.
5.1.18 Annual Product Review.
5.1.19 Co- ordination with Regulatory Department.
5.1.20 Handling of Market Complaints.
5.1.21 Document Numbering System.
5.1.22 Batch Release / Rejection
5.1.23 Product Recall.
5.1.24 Handling of Return Goods.
5.1.25 Stability Studies of Products.
5.1.26 Management of Control Sample.
5.1.27 Reference Sample Management.
5.1.28 Preparation, Approval of SOP’s, BMR, BPR and Protocols.
5.1.29 Preparation of Calibration Policy and Implementation.
5.1.30 Internal audit.
5.1.31 Handling of ID. labels.
5.1.32 Analysis on contract basis.
5.1.33 Handling of OOS in stability.
5.1.34 Signature authorization in QA & QC department.
5.1.35 Handling of rounding of figures in QA & QC.
5.1.35 Artwork Approval
5.2 In the absence of respective designated as assigned, responsibility shall be carry forward to his or her designee.
6.0 ABBREVIATIONS:
BMR :Batch Manufacturing Record
BPR :Batch Packing Record
cGMP :Current Good Manufacturing Practices
CAPA :Corrective and Preventive Action
GLP : Good Laboratory Practices
HVAC :Heating Ventilation and Air Conditioning
OOS :Out of Specification
OOT :Out of Trend
WHO :World Health Organization
TRS :Technical Report Series
SOP : Standard Operating Procedure
QA : Quality Assurance
QC :Quality Control
SOP :Standard Operating Procedure
ID : Identification
8.0 ANNEXURES:
Not Applicable
9.0 DISTRIBUTION:
Master Copy : Quality Assurance Department.
Controlled Copy : Quality Assurance Department.
10.0 REFERENCES:
In House