Manufacturing Facility Risk Assessment

1.0 PURPOSE

The purpose of this document is to provide a procedure for performing of quality risk management and evaluation of current controls and procedures for risk associated with the introduction of new equipment in the facility and identified the potential risk and risk mitigation plan for the same.

2.0 SCOPE

This QRM document is applicable to Introduction of new Equipment in the facility

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1.0 PURPOSE

The purpose of this document is to provide a procedure to identify the failure modes / process risks from Receiving of Materials to dispatch of Finished Goods, verify existing controls and provide recommendations for mitigation of residual risks, if any.

This risk assessment shall emphasize on potential risks of contamination and cross-contamination of product during receiving, storage, processing and dispatch of solid oral dosages form.

2.0 SCOPE

This QRM document is applicable to Risk assessment of  Tablet manufacturing and packing process.

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1.0 PURPOSE

The purpose of this document is to provide a procedure to identify the failure modes / process risks from Receiving of Materials to dispatch of Finished Goods in Dry powder injection facility, verify existing controls and provide recommendations for mitigation of residual risks, if any.

This risk assessment shall emphasize on potential risks of contamination and cross-contamination of product during receiving, storage, processing and dispatch of  Dry Powder Injection Facility.

2.0 SCOPE

This QRM document is applicable to Risk assessment of  Dry Powder Injection manufacturing and packing process.

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