by 1.0 OBJECTIVE
This SOP gives the responsibilities of Quality Assurance (QA) personnel.
2.0 SCOPE
This SOP is applicable for QA department.
3.0 RESPONSIBILITY
QA-Executive shall be responsible
4.0 ACCOUNTABILITY
Head- Quality Assurance
5.0 PROCEDURE
5.1 Establishing and approving Quality Policy, procedures and ensuring their compliance.
5.2 Approval of Standard Operating Procedures, Methods of Analysis, Specifications and Master Formulae Records.
5.3 Handling and disposition of market complaints.
5.4 Handling and disposition of deviations.
5.5 Co-coordinating for product recall, if any.
5.6 Approval and disposition of change control, out of specification, incident report.
5.7 Control, distribution and retrieval of quality records like SOPs, Method of Analysis, Specifications and Technical Directions.
5.8 Preparation, updation and approval of Site Master File, Quality Manual and Validation Master Plan.
5.9 Review and approval of artwork.
5.10 Evaluation and review of corrective and preventive actions.
5.11 Conducting Internal audits of plant and facility to appraise the effectiveness of various Quality Assurance Systems ensuring maintenance of cGMP status.
5.12 Co-ordinating external agency audits.
5.13 Co-ordinating with other departments for implementation of validation activities.
5.14 Conducting audits for vendors of raw and/or packaging materials.
5.15 Issuance of Batch Manufacturing Records to production and review the same after completion of the manufacturing activity and thereafter release of batch for sales, storage and distribution.
5.16 Reviewing data of new products under development.
5.17 Review of stability data
5.18 Execution of technology transfer documents related to both, process and analytical method transfer from Contract givers.
5.19 Preparation of annual product review.
5.20 Participating and co-coordinating in product registration activities through external consultants or otherwise.
5.21 Preparation of SOPs related to Quality Assurance Department and checking and reviewing for SOPs of other departments.
5.22 Assigning of item code to finished product and updating the respective list.
5.23 Execution of failure investigation.
5.24 Final release for dispatch of the finished goods.
5.25 Control sample management
5.26 Line clearance, in-process checks and management of shop floor.
5.27 Retention of records
6.0 TRAINING
Trainer : Head – Quality Assurance
Trainees: Staff of all the departments
7.0 DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
8.0 ATTACHMENT
| Sr. No. | Annexure No. | Title | Format No. |
| 1 | NA | NA | NA |
9.0 REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
