SOP of 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 :
       Ensure all operations in Production / QC / Stores are performed in accordance
with the relevant cGMP guidelines.
      To accompany External audit personnel during inspections and prepare corrective
action plan in conjunction with Production / QC / Stores and ensure implementation
of corrective actions.
       To approve all master documents BMR, MFR, MSDS, Specifications, SOP,
Validation Protocols and reports.
       Approve the artwork in co-ordination with Quality Control Department,
Packaging Development Department and Production.
       To issue BMR each page having unique signature for authenticity.
       To review and control BMR and QC data for each batch of product and give final
release before dispatch of the product.
       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.
       To co-ordinate all validation activities associated with production and QC i.e.
process, equipment, utility, analytical method, testing equipments.
       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.
       To register all customer complaint and co-ordinate investigation activities with
QC / Production and to prepare final report.
       To provide relevant cGMP training to new entrants and retraining to all qualified
production / quality control staff.
       To keep track of technical training schedule of Production / QC and keep detailed
training file for all such activities.
       To handle all out of specifications results as per SOP.
       To ensure all relevant QA in process checks and line clearances are performed in
day to day production activities.
       To review and check periodically:
      Maintenance schedules.
       Pest control schedules.
       Stability test results.
       Calibration of equipments.