Q.A. Is Responsible For:

Maintaining GMP At All Stages Of Production And Control.

Review Of Production Records.

Review Of Product Specifications And Test Procedures

Release Of Finished Goods.

Quality Audits

Stability Studies

Vendor Validations

Product Complaints And Recall

Validation & Qualification.

Calibration Of Verification.

Elements Of Q.A. System

Specification And Clearly Written Job Responsibility For Each And Every Employee.

Specify And Clearly Written Standard Operating Procedure And Work Instructions.

Validated Processing Procedure.

Specification Of Raw Material, Packing Material, Work In Progress And Finished Goods.

Validation Analytical Method.

Data Collection And Statistical Evaluation Of Quality.

Vendor Audits.

A Complete Validation Master Plan.

A Well-Designed Complaint Handling And Product Recall System.

Develop/Issue/ Preview Of All Protocol Jointly With User Department.

Review Of All Material Documents / SOP’s

Quality Audits

Stability Studies

Vendor Validations.

Product Complaints And Recall.

Self Inspection.

Self Inspection

A Self-Inspection Team Comprising The Production Manager, Quality Assurance Manager, Quality Control Manager And Maintenance Manager Conduct Integral Audits Periodically As Per An Established Plan.

An Inspection Report Is Prepared After The Inspection Of Facilities And Systems. The Report Is Circulated To The People Concerned With An Action Plan And Target Date For Its Completion. External Audits Are Also Carried Out By Various Agencies From Time To Time And The Compliance With Any Points Raised Is Documented.

Review Of Results

The Efficacy, Safety And Quality Of The Product Are Ensured Through A Series Of Validations Carried Out Upon Manufacture And Analysis. Each Production Batch Is Reviewed By QA For Completeness Of Manufacturing, Analysis, Packing, IPQC, Yields Deviations Etc. Prior To The Release Of The Batch.

Appssessment Of Suppliers

The Company Maintains Its Own Vendor Audit And Appraisal System To Evaluate Suppliers.

Vendor Approval

A Complete Vendor Validation Plan Takes Care Of Suppliers Of Critical Starting Material And Packing Materials Which Are Assessed By Routine Audits/ By Questionnaires.

Approval/Authorization, Distribution, Control, Review, Storage And Destruction Of Production Records

Review Of Product Specifications And Test Procedures

Release Procedure (Finished Products)

Products Are Analyzed As Per Laid Down Specifications. The Products That Meet The Specification Are Released As APPROVED And May Be Dispatched. Any Product Not Meeting Specifications May Be Retested As Per SOP For OOS And Is REJECTED If It Does Not Comply.

Product Recalls

Quality Assurance Dept Would Make The Decision If A Recall Is Necessary And Define The Class Of Recall.