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Validation Master Plan for Pharmaceutical Industry

Author of the document Prepared by         Designation: Signature Date: Reviewer of the document for correctness Reviewed by:         Designation: Signature: Date: Approver of the document for use Approved by: Designation: Signature: Date:         Table of contents: 1. Validation policy 2. Scope 3. Responsibility 3.1 Production department 3.2 Quality control department 3.3 Engineering department 3.4 Quality assurance department 4. Site...

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     activities. Responsibility: Engineering, Quality Assurance Procedure: 4.1. Engineering...

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 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: Production, Quality Control, Engineering, other concerned department, Quality assurance Procedure: 4.1 For...

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. ...

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 on few principles that are listed below: (B) Selecting worst...

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 at: info@pharmastate.com   For any suggestions & feedback, write to 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 at: info@pharmastate.com   For any Feedback or suggestion mail at: info@pharmastate.com Weblink...

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