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FAT – Factory Acceptance Test

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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 instrument associated with equipment ii) Verify PLC (Programmable Logic Control) validation of equipment iii)  Control Panel Testing to perform...

Disintegration Test for Drugs

(A) Subjective:  Procedure for performing Disintegration test. (B) Purpose: This procedure is applicable for performing dissolution test on drugs used in pharmaceutical company. (C) Name of the Apparatus: Disintegration Test Basket. (D) What does Disintegration Test Indicates?...

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...

Working Principles for Dynamic and Static Pass Boxes

(1) Dynamic Pass Box: Procedure on the working of Dynamic Pass Box. (A) Objective:  This working principle is applicable for usage of Dynamic Pass Box in formulation plant of pharmaceutical company. (B) Responsible Person:  Production Officer/ Executive are the...

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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