VIAL WASHING MACHINE PQ PROTOCOL

VIAL WASHING MACHINE PQ PROTOCOL TABLE OF CONTENTS S. No. Description 1.0 Protocol approval 2.0 Overview 2.1 Purpose 2.2 Scope 2.3 Responsibilities and identification of execution team 3.0 Pre-Validation requirement 4.0 Equipment description 5.0 Validation procedure 6.0 Sampling plan and Acceptance criteria 7.0 Validation report 8.0 Validation approval 9.0 Observed deviation 10.0 List of attachment … Read more

SOP for operation of Strip Packing Machine

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SOP for operation of Strip Packing Machine Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of Strip Packing Machine. Scope This SOP is applicable for the operation of Strip Packing Machine used to pack the Tablets and Capsules into Strips in the formulation plant. Responsibility Production Operator/ Technician shall be responsible … Read more

SOP for operation of de-dusting and polishing machine

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SOP for operation of de-dusting and polishing machine Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of de-dusting and polishing machine. Scope This SOP is applicable for operation of de-dusting and polishing machine used to polish the Filled Capsules in Capsule Filling Area to the formulation plant. Responsibility Production Operator/ Technician … Read more

SOP on operation of Paste Kettle

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SOP on operation of Paste Kettle Standard Operating Procedure (SOP) Objective To lay down the procedure for operation of Paste Kettle Scope This SOP is applicable for operation of Paste Kettle in the formulation plant. Responsibility Production Operator/ Technician – For operation of the equipment. Production Officer/ Executive – To ensure that operation of the … Read more

Tablets In Pharma Industry

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Tablets In Pharma Industry NOTE- The provisions of this monograph do not necessarily apply to tablets intended for use other than by oral administration such as Vaginal preparations or Or mucosal preparations, and to lozenges, oral pastes and oral gums. Introduction Tablets are solid dosage forms each containing a unit dose of one or more … Read more

CAPSULES IN PHARMA INDUSTRY

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CAPSULES IN PHARMA INDUSTRY Capsules are solid dosage forms in which the drug substance is enclosed within either a hard or soft soluble shell. Generally, the shells are formed from gelatin. The capsule may be regarded as “container” drug delivery system, which provides a tasteless/odorless dosage form without the need of a secondary coating step, … Read more

Disintegration Test in Pharma Industry

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Disintegration Test in Pharma Industry This test determines whether dosage forms such as tablets, capsules, boluses pessaries, and suppositories disintegrate within a prescribed time when placed in a liquid medium under the prescribed experimental conditions. For the purpose of this test, disintegration does not imply complete solution of the dosage unit or even of its … Read more

SOP for cleaning of FBD bag

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SOP for cleaning of FBD bag Standard Operating Procedure (SOP) Objective To lay down a procedure for cleaning of FBD bags. Scope This SOP is applicable for the cleaning of FBD bags in the formulation plant. Responsibility Production Operator/ Technician – For cleaning of the equipment. Production Officer/ Executive – For checking the cleanliness of … Read more

SOP for operation of Tablet Inspection Machine

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SOP for operation of Tablet Inspection Machine Standard Operating Procedure (SOP) Objective To lay down the procedure for operation of Tablet Inspection Machine. Scope This SOP is applicable for the operation of Tablet Inspection Machine in the formulation plant. Responsibility Production Operator/ Technician – For operation of the machine. Production Officer/ Executive – To maintain … Read more

SOP for operation of Auto coater

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SOP for operation of Auto coater Standard Operating Procedure (SOP) Objective To lay down a procedure for operation of Auto coater. Scope This SOP is applicable for operation of Auto coater in the formulation plant. Responsibility Production Operator/ Technician – For operation of the machine. Production Officer/Executive -To maintain proper functioning of the equipment & … Read more

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