Quality Assurance

The Quality Assurance (QA) department is responsible for evolving, implementing and monitoring quality assurance activities having an impact on the quality of product and is independent of other functions in the Plant. QA is adequately staffed with competent personnel and has suitable and sufficient premises, equipment and facilities.

QA plays a role in identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. QA engages in system development, controlling and auditing of cGMP and

implementation of ISO 9001:2015 Quality Standard practices in the Plant through the Plan-Do-Check-Act cycle.

All activities of QA are carried out effectively by the following sections:

    1. In-process quality assurance (IPQA)
    2. Compliance
    3. Process Validation
    4. Training
    5. Documents Preparation, Distribution and Archiving

To supervise the effectiveness and applicability of the quality assurance system, QA performs the following activities:

    1. Implementation of cGMP and Training
    2. Process Control Including Line Clearance, Inspection, In-process Checks & Sampling
    3. Managing Change Control
    4. Handling of Deviation & Investigation
    5. Handling of Incidence
    6. Handling of Online Rejection
    7. Impact Analysis /Product Quality Risk Assessment
    8. CAPA Management of the site
    9. Self-inspection/Internal Auditing and Follow-up of External Audits
    10. Annual Product Quality Review (APQR)
    11. Market Complaints Handling & Product Recall
    12. Validation of Manufacturing Process
    13. Review of Product Stability Study Data
    14. Review of Quality Manual, Site Master File, VMP and other Quality Documents
    15. Documents like SOP, BMR, BPR, Master List Preparation, Distribution and Archiving
    16. Art-work of Packing Materials Checking, Approval and Controlling Retention Samples & Obsolete Documents Management

To communicate with related departments about quality issues as and when required

For proper coordination among the different departments, we developed a Quality Operation Management System which ensures that intended product quality standards are consistently achieved. QMS is dependent on an organizational structure with clearly defined roles & responsibilities together with the necessary resources to fulfill the responsibilities. “Quality we assure” is our commitment and we are marching onward to achieve this goal.