SOP for Product Recall in Pharmaceutical Industry
1. Objective To lay down a procedure for product recall. 2. Scope This procedure applies to the recall of a batch or batches of any…
Category: Quality Assurance
SOP for Performance Qualification of LAF, RLAF and Dynamic Pass Box
1. Objective: To lay down a procedure for performance qualification of LAF, RLAF and dynamic pass box. Scope: This procedure is applicable for…
STABILITY STUDY PROTOCOL TEMPLATE – Pharmaceutical Industry
STABILITY STUDY PROTOCOL TEMPLATE (FOR ASPIRIN TABLETS 75mg) Prepared By Checked By Approved By Designation: Designation: Designation: Date: Date: Date: Sr.…
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…
SOP for Microbiological Analysis of Compressed Air and Nitrogen
1. Objective: To lay down a procedure for microbiological analysis of compressed air and Nitrogen. 2. Scope: This procedure is applicable for microbiological analysis of…
SOP for Building Maintenance Program in Pharmaceutical Industry
1. Objective: To lay down a procedure for building maintenance programme. 2. Scope: This procedure is applicable for maintenance activity of building like civil work,…
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…
SOP for Failure Investigation in Pharmaceutical Industry
Objective: To lay down a procedure for failure investigation. Scope: This procedure is applicable for investigation of process or system failure having impact on…
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…
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