Responsibility of Quality Assurance personnel in Pharmaceuticals

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 manufactured products are of the quality required for their intended use.

As per Oxford Reference Dictionary the term quality defines as –“A standard of how good something is as measured against other similar things.”

During the 1980s, the concept of company quality with the focus on management and people came to the fore in the U.S. It was considered that, if all departments follow & approached quality with an open mind, success was possible if management led the quality improvement process.

QA is not only limited to Pharmaceutical manufacturing, but also can be applied to any business or non-business activity, which includes design, consulting, banking,food Industry, beverage industry,cosmetic Industry, insurance, computer software development, retailing, investment, transportation, education, and translation etc.

Quality Assurance is A supporting department to other departments &
a decision maker throughout the firm/Organization.

Quality Assurance basically divided into three parts i.e In process Quality assurance or Manufacturing assurance or Shop floor Quality assurance, Documentation Quality assurance & Analytical assurance.

In process Quality assurance or Manufacturing assurance or Shop floor Quality assurance is responsible to ensure the quality of the drug products from Raw material store or warehouse to Release or Dispatch.

Documentation Quality assurance is related to the document related activities which includes Training, Quality Management System, Document Issuance, Market Compliant, Audit Compliance etc.

Analytical Quality assurance is responsible to review the analytical documents which are generated after analysis of drug Products.

Pl find the below detail responsibilities of Quality Assurance or Quality Unit (Starting from Trainee to Head QA) throughout the Plant/Organization (But Not Limited to) .

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 Management.


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