SOP on job responsibilities of personnel working in Quality Assurance.

Objective: To lay down the procedure for providing the job responsibilities of personnel working in quality assurance department.

Scope: The scope of this SOP is limited to the Quality Assurance department at formulation plant.

Responsibility: Head – Quality Assurance is responsible for assigning the job responsibilities of the personnel working in the Quality Assurance.

Accountability: Head-Q.A. shall be accountable for implementation and compliance of this SOP.

Procedure: Job Responsibility of Quality Assurance personnel are given below.

Job Responsibility of Quality Assurance:

Total responsibility of Quality assurance at unit level.

Creating and authorizing quality systems and procedures.

Reviewing and challenging specifications and test methods.

Reviewing vendor quality management.

Interacting with manufacturing and engineering personnel in planning for the construction, alteration, renovation, or purchase of premises, plant or equipment.

Interacting with the personnel of other departments concerned with the development of electronic data processing systems, wherever these are concerned with materials or products.

Ensure investigation for out-of specification analysis, process and procedure deviations and product failures are appropriately performed and documented and appropriate corrective and preventive actions based on the results of the investigations are identified and implemented.

Improving in- process controls.

Critically examining the environment with a view to minimizing product contamination.

Ensuring that goods are produced according to protocols accepted for registration. Oversee the communication and distribution of information on implemented changes, including those that may impact regulatory submissions.

Be notified of all circumstances which may affect the quality of products, whether before or after release for sale.

Having the final responsibility to management for the testing and release or rejection of all materials and products subject to the quality control system.

Be empowered to take samples for testing from any material or substance relevant to product quality.

Establish or approve master batch and packaging documents.

Evaluate any re-processing or re-working of products.

Certification of Export consignment as per export order.

Participate in the investigation of deviations discrepancies or test failure.

Evaluate complaints relating to product quality received from any source.

Review periodically the records relating to each product and report on compliance standards, problems if any and recommended action.

Periodic review of all quality functions and procedure for appropriateness and validity.

Examine returned goods, to determine whether they should be released, reprocessed or destroyed.

The person responsible for Quality Assurance should be part of the decision-making process in all matters that affect the quality of products including development, production, laboratory, storage, distribution, vendors and third party contractors.

Ensure that Pharmaceutical products are designed and developed in a way that takes account of the requirements of cGMP and other associated codes such as cGLP and cGCP.

Responsible to maintain all necessary controls on starting materials, intermediate products and bulk products and other in-process controls.

Ensure that Pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of Pharmaceutical products.

To conduct the self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system.

DMF preparation and preparation of documents required for product registration cell.

Assure process and cleaning qualification / validation and re-qualification / re-validation are properly planned, conducted and documented.

Assure that appropriate calibration and preventive maintenance of manufacturing equipment and laboratory instruments are conducted as scheduled.

Perform annual reviews of all drug products to assure that quality standards are appropriate and being met.

Serve as the focal point for communications with regulatory bodies concerning inspections, marketing applications and regulatory policies and procedures.

To fulfill the training need as per current needs with respect to cGMP, cGLP, safety & Hygiene and Job.

Any other assignment allocated by Head Q.A. & Corporate Q.A.

Review of water system.

Release and rejection of batches.

Evaluation of product by test manual controlled use of product, competitive evaluation of product and product monitoring in the market.

Inspecting of inter laboratory test and measuring the inspector accuracy.

Audit of packaging transportation and storage of product.