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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 carried   out at factory premises. Responsibility: Production, warehouse, quality...

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. ...

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 equipment used for measurement. Responsibility: Quality control, Production, Warehouse,...

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...

FRIABILITY TEST

(A) Subjective:  Procedure for performing Friability test on Tablets. (B) Purpose: This procedure is applicable for friability test on tablets and calibration of friabilator used in pharmaceutical company. (C) Name of the Apparatus: Friabilator. (D) Significance of...

Cleanroom Standards – ISO Guidelines

(A) Background: Before global cleanroom classifications and standards were adopted by the International Standards Organization (ISO), the U.S. General Service Administration’s standards (known as FS209E) were applied virtually worldwide. However, as the need for international...

Procedure for Cleaning and Monitoring of Clean Room Pass Boxes

  Cleaning of Clean- Room Pass Boxes: (A) Subject:  Procedure for Cleaning of Class- Room Pass Boxes. (B) Purpose: This procedure is applicable for Cleaning of Clean- Room Pass Boxes used in the formulation plant of pharmaceutical...

Clean Rooms In Pharmaceutical Manufacturing

A  Clean- Room is an environment in which several parameters (like Contamination, Pressurization, Temperature & Humidity and Personnel Access) are controlled, monitored and maintained. Basically Clean- Room is an area in which the Quantity...

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