Note : Some Responsibility of Quality Assurance may vary from

organization to organization.

1. To ensure implementation of cGMP practices on the shop floor

during manufacturing activities.
2. To follow Good Documentation practices and safety instructions.
3. To provide Line clearance on the shop floor (Manufacturing,
Packaging and Warehouse).
4. In process checks during manufacturing & packing activities.
5. Sampling of raw materials, packing materials, intermediates, and
finished products.
6. Spot check to verify that operations and systems comply with
relevant requirements.
7. Review of the executed documents and review the documents for
compliance including log books, Batch Manufacturing & Packing records,
Validation protocols and reports, etc.
8. To investigate the cause of any non conformance and its corrective /
preventive action.
9. Calibration of In process Quality Assurance (IPQA) instruments.
10. To ensure the preparation, Issuance, Revision and Retrieval of the
documents like Formats, Log books, Batch records & Protocols etc
11. To ensure proper document control on issued document and master
documents.
12. Control Samples Management.
13. To prepare the Annual Product Quality Review (APQR) and ensure
its implementation.
14. Preparation of protocols and performing Swab sampling for cleaning
validations.
15. To Prepare & review protocols and support execution of process,
cleaning validation.
16. To perform sampling for hold time studies.
17. Monitoring of the qualification, calibration and Preventive
maintenance schedule for equipment’s and instruments at shop floor.
18. Preparation and review of departmental SOP’s for cGMP compliance.
19. Preparation of of Master Formula Record , Batch Manufacturing
Record , Mater Packing Record & Batch packing Records
20. To approve or reject starting materials, packaging materials, and
intermediate, bulk and finished products in relation to their specifications.
21. Compilation and review of the Batch records, Certificate of Analysis,
Analytical protocol, etc which are required for release of batches.
22. Review & approve SOPs, change controls, deviations, Annual
Product Quality Reviews, Validation Master Plan (VMP) & Site Master File
(SMF).
23. To review the investigation reports for Incident reports, Out of
calibrations, Out of specifications, Out of trends etc.
24. Review of regulatory requirements and its compliance.
25. Periodic review of all quality functions and procedure for
appropriateness and review of related documents.
26. Responsible for all SAP, LIMS, ERP etc. transactions related to
release, reject or block or unblock of raw material, packaging material, in
process product and finished product.
27. To Provide Final Decision.
28. To check Tracking, implementation & effectiveness of
corrective & preventive action (CAPA) .
29. To review & Approve the investigation reports, Market Compliant, Out
of specifications & Out of trends etc.

Conclusion :

Quality Assurance is not only responsible to provide Quality products or to

ensure Quality throughout the Firm/Organization but also it is the
responsibility of individual personnel as well as the Senior Managemen

1.What is Quality Assurance :

Quality Assurance is a deep concept covering all matters that individually

or collectively influence the quality of a product. It is the complete & whole
of the arrangements made with the object of ensuring that the
manufactured products are of the quality required for their intended use.

2. Responsibility of Quality Assurance:

In process checks during manufacturing & packing activities, Providing Line

clearance in Manufacturing, Packaging and Warehouse, Sampling of
products in manufacturing and packing, Reviewing the manufacturing and
packing batch record, Issuance of  documents to other departments,
calibration of Instruments, Providing training to other department, Ensuring
online documentation and compliance throughout the plant,Review &
approve Standard operating procedure, change controls and deviations.

3. What is tablet :

Tablets is defined as the solid unit dosage form of medicines with

suitable excipients and prepared either by molding or by compression. It
comprises a mixture of active substances and excipients, usually
in powder form, pressed or compacted from a powder into a solid dose.

4. Name any three tablet processing problems :