Audits
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...
Audits
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...
Audits
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.
...
Audits
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...
Audits
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...
Audits
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...