1.0 PURPOSE :
To establish Quality Assurance System in the Organisation.
2.0 SCOPE :
To provide the guidelines for the proper implementation of the Quality Assurance System.
3.0 RESPONSIBILITY :
All QA personnel.
4.0 PROCEDURE :
4.1. Ensure all operations in Production / QC / Stores are performed in accordance with the relevant CGMP guidelines.
4.2. To accompany WRC / External audit personnel during inspections and prepare corrective action plan in conjunction with Production / QC / Stores and ensure implementation of corrective actions.
4.3. To approve all master documents BMR, BPR, Specifications, Sop’s, Validation Protocols & reports.
4.4. To approve the artwork in co-ordination with Quality Control Department, Packaging Development Department and production.
4.5. To issue BMR/BPR each page having unique signature for authenticity.
4.6. To review BMR/BPR and QC data for each batch of product and give final release before dispatch of the product.
4.7 To ensure that no changes are made in formula, process, with out information and approval from license holder/customer. In order to regularise change in equipment, facility, utility, primary pack and analytical procedure, raise change control for approval.
4.8 To co-ordinate all validation activities associated with production and QC i.e. process, equipment, utility, analytical method, testing equipments.
4.9. To prepare schedule and perform Internal audits to ensure GMP compliance. Corrective Action Plan to be put in place for the observation and reports there of shall be filed.
4.10 To register all customer complaint and co-ordinate investigation activities with QC / Production and to prepare final report.
4.11 To provide relevant CGMP training to new entrants and retraining to all qualified production / quality control staff.
4.12 To keep track of technical training schedule of Production / QC and keep detailed training file for all such activities.
4.13 To handle all out of specifications results as per SOP.
4.14 To ensure all relevant QA inprocess checks and line clearances are performed in day to day production activities.
4.15 To review and check periodically :
4.15.1 Maintenance schedules.
4.15.2 Pest control schedules.
4.15.3 Microbial environment monitoring.
4.15.4 Stability test results.
4.15.5 Calibration of equipments.