Audit Process
Vendor is an individual or company that sells goods or services to someone else in the economic production chain. An audit is a independent, systematic…
Category: Audits
Process For Vendor Audit
Audit Process: The process of managing the Vendor Audit Program is conducted in the following phases: Initiation Pre-audit & Audit Planning Preparation of Audit Audit…
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…
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…
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…
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…
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:…
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…
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