SOP for Computer System Validation in Pharmaceutical Industry
Objective: To lay down a procedure for computer system validation. Scope: This procedure is applicable for all computerized system used in GxP regulated activities. This…
Category: Validation
SOP for Management of External Calibration/Validation Agency in Pharmaceutical Industry
Objective: To lay down a procedure for evaluation and approval of external calibration/validation agency. Scope: This SOP is applicable for all external service providers for calibration/validation …
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 Validation/Qualification Policy in Pharmaceutical Industry
Objective: To lay down a procedure for validation/qualification policy for equipment, system and instruments. Scope: This procedure is applicable for production/engineering equipment, utilities and laboratory instruments. Responsibility:…
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…
Cleaning Validation in Pharmaceutical Industry
“It is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing or manufacturing of medicinal products” It is based…
Performance Qualification (PQ) in Pharmaceutical Industry
Copyright Notice: This Article/SOP/Compilation/Published Content is protected by Indian & International Copyright Laws. Reproduction and Distribution of the same without written permission is prohibited. Mail us…
SITE ACCEPTANCE TEST (SAT)
Copyright Notice: This Article/SOP/Compilation/Published Content is protected by Indian & International Copyright Laws. Reproduction and Distribution of the same without written permission is prohibited. Mail us…
FAT – Factory Acceptance Test
Copyright Notice: This Article/SOP/Compilation/Published Content is protected by Indian & International Copyright Laws. Reproduction and Distribution of the same without written permission is prohibited. Mail us…
Operational Qualification (OQ) for Equipments
PROTOCOL Requirements are as follows: a) Validation Team b) Objective c) Scope d) Responsibility e) Equipment description f) Operation Checks: i) Verify calibration of…
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