Role of Quality Assurance

1.0        Purpose       :  To establish Quality Assurance System in the Organization.

2.0       Objective   : To provide a documented procedure for establishment of Quality Assurance System in the Organization.

3.0        Scope           : To provide the guidelines for the proper implementation of the Quality

Assurance System.

4.0      Responsibility  :

·        All QA personal. 

5.0       Procedure :

Ø      Ensure all operations in Production / QC / Stores are performed in accordance with the relevant cGMP guidelines.

Ø      To accompany External audit personnel during inspections and prepare corrective action plan in conjunction with Production / QC / Stores and ensure implementation of corrective actions.

Ø      To approve all master documents BMR, MFR, MSDS, Specifications, SOP, Validation Protocols and reports.

Ø      Approve the artwork in co-ordination with Quality Control Department, Packaging Development Department and Production.

Ø      To issue BMR each page having unique signature for authenticity.

Ø      To review and control BMR and QC data for each batch of product and give final release before dispatch of the product.

Ø      To ensure that no changes are made in formula, process with out information and approval from license holder/customer. In order to regularize change in equipment, facility, utility, packaging and analytical procedure, raise change control for approval.

Ø      To co-ordinate all validation activities associated with production and QC i.e. process, equipment, utility, analytical method, testing equipments.

Ø      To prepare schedule and perform Internal audits to ensure GMP compliance. Corrective Action Plan to be put in place for the observation and shall be filed.

Ø      To register all customer complaint and co-ordinate investigation activities with QC / Production and to prepare final report.

Ø      To provide relevant cGMP training to new entrants and retraining to all qualified production / quality control staff.

Ø      To keep track of technical training schedule of Production / QC and keep detailed training file for all such activities.

Ø      To handle all out of specifications results as per SOP.

Ø      To ensure all relevant QA in process checks and line clearances are performed in day to day production activities.

Ø      To review and check periodically:

ü      Maintenance schedules.

ü      Pest control schedules.

ü      Stability test results.

ü      Calibration of equipments.