Wednesday, November 24, 2010
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
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.
Pest control schedules.
ü Stability test results.
ü Calibration of equipments.