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
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.

1 comment:

  1. how is the batch size put on BMR

    ReplyDelete

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