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…
Category: Quality Control
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 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 Management of Chemicals used in Purified Water Plant in Pharmaceutical Industry
Objective: To lay down a procedure for management of chemicals used in purified water plant. Scope: This procedure is applicable for chemicals used in purified…
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 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 Repacking of Products in Pharmaceutical Industry
1. Objective: To lay down a procedure for repacking of finished products. Scope: This procedure is applicable for repacking activities of finished products to be…
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 Calibration Management in Pharmaceutical Industry
Objective: To lay down a procedure for management of calibration procedure. Scope: This procedure is applicable for QC instruments, production equipment, utility service and all other…
SOP on Handling Out Of Trend (OOT) Results
1. Objective: To lay down a procedure for handling out of trend (OOT) results during laboratory analysis. Scope: This procedure is applicable for chemical, physico-chemical…
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