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SOP of QA Role

The document outlines the standard operating procedure for the role of quality assurance in an organization. It describes establishing a quality assurance system to ensure compliance with cGMP guidelines through monitoring production, quality control, and storage operations. It also details responsibilities like approving documents, batch records, and change controls, conducting audits, handling complaints, and providing training. The quality assurance team is responsible for releasing products and reviewing quality data.

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1K views

SOP of QA Role

The document outlines the standard operating procedure for the role of quality assurance in an organization. It describes establishing a quality assurance system to ensure compliance with cGMP guidelines through monitoring production, quality control, and storage operations. It also details responsibilities like approving documents, batch records, and change controls, conducting audits, handling complaints, and providing training. The quality assurance team is responsible for releasing products and reviewing quality data.

Uploaded by

Yousif
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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.

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