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Audits

Internal Audits

Internal audits are a key management control activity that ensures the internal business processes are consistent. An internal audit is a form of audit process that occurs within the organisation to assess the conformity...

SOP for Quality Management System (Documentation) in Pharmaceutical Industry

 Objective: To lay down a procedure for origination and review of the Site Master File, Quality     Manual, Quality Policy, SOPs, forms and logs. Scope: This procedure is applicable for following documents: - Quality Manual/Policy -  Site...

SOP for Incident Handling in Pharmaceutical Industry: PharmaState

1. Objective: To lay down a procedure for handling of incidents. Scope: This procedure is applicable for accidental and untoward events occurring in factory premises. Incidents may occur even though standard procedures are not violated. ...

SOP on Data Integrity in Pharmaceutical Industry

Objective: To lay down a procedure for data integrity as part of quality management system. Scope: This procedure is applicable for all the data associated with GxP and quality management system. Responsibility: All department...

SOP for finished product Inspection and Release in Pharmaceuticals

Objective: To lay down a procedure for finished product inspection and release. Scope: This procedure is applicable for all type of finished pharmaceutical product. Responsibility: Quality assurance, Warehouse and Production. Procedure: 4.1 Physical...

FORM 483- Know more

The US Food and Drug Administration (FDA) conducts regular inspections of regulated pharmaceutical finished dose and active pharmaceutical ingredients (API) to determine whether the manufacturing facility is compliant to the guidelines set forth by...

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