SOP For Functions Of Quality Assurance Department

 

1.0              OBJECTIVE:

            To lay down this procedure describe the functions of Quality Assurance Department.

2.0              SCOPE:

This SOP is applicable to all the personnel in Quality Assurance Department at -----------------------------

3.0              RESPONSIBILITY:

            The responsibility lies on all employee of Quality Assurance department.

4.0              ACCOUNTABILITY:                       

            The Accountability lies upon Quality Assurance Head.

5.0              PROCEDURE:

5.1              Issuing and control of records of all departments.

5.2              Preparing, approval and authorization of protocols.

5.3              Handling and procurement of manufacturing license and other certificates.

5.4              Maintain the batch authorization system.

5.5              Prepare the batch numbering system of drugs products.

5.6              Maintains and check the log book, formats of all departments.

5.7              Check on all in process steps of manufacturing unit.

5.8              Maintenance of records of quality assurance department like SOP formation, validation process, stability study reports, cleaning and sanitary records, personnel training and personal hygiene program.

5.9              Conducting and preparing the validation of process and validation of master plan.

5.10          Cross checking of all stores and production area to avoid the mix up contamination and cross contamination.

5.11          Cross checks for area clearance and packing line clearance.

5.12          Control the processes and production.

5.13          Auditing of vendors and maintained the records.

5.14          Maintain the change control system, incident report, planned and unforeseen deviations.

5.15          Handling of non-conformance reports, reprocessing and rework due to nonconformance of product.

5.16          Review of batch production record and annual product review.

5.17          Collections of control sample, periodically physical observation and maintenance of control samples.

5.18          Inspection of goods for dispatch and batch releasing.

5.19          Handling and investigation of product complaints.

5.20          Maintain the system for product recall.

5.21          Handling of returned goods.

5.22          Destruction of waste and rejected drug products and its components.

5.23          Destruction of records and documents.

5.24          Cleaning and sanitization of drain.

5.25          Cleaning and sanitization of manufacturing area.

5.26          Cross checks the Pest control activity, fumigation procedure and preparation of IPA, NaOH solution.

5.27          Prepare the site master file, quality manual, calibration and validation schedule, Annual training planner.

5.28          Prepare and conduct self inspection schedule.

5.29          Checking of all qualification of equipments.

5.30          Verifying of area qualification.

 

6.0              LIST OF ANNEXURE AND FORMATS:

 

Sr. No.	Title of Format	Format No.
01	NA	NA

 

7.0              REFERENCE:

7.1              SOP-QA-001

7.2              F/QA-001-01

7.3              SOP-QA-014

 

 

8.0              REVISION HISTORY:

 

Sr. No.	Date	Reason for Revision	Revision No
1.	31/10/2018	New SOP	R0
2.	31/10/2020	Schedule Revision	R1

 

9.0              ABBREVIATIONS:

                                    

Sr. No	Abbreviations	Details
01	SOP	Standard operating procedure
02	NaOH	Sodium hydroxide solution
03	IPA	Isopropyl alcohol

 

END OF DOCUMENT