sop for placebo batch 1.0 PURPOSE To provide a procedure for numbering, manufacturing and packing of placebo batch and control to be followed for placebo batch. 2.0 SCOPE 2.1 Applicable to all placebo batches 3.1 References In house 3.2 Attachments 3.2.1 Attachment- I : Batch Manufacturing Record of Placebo Batch for Analytical … Read more
sop for Cleaning of Ampoule Filling and Sealing Machine 1.0 OBJECTIVE: To lay down a Procedure for Operation and Cleaning of Ampoule Filling and Sealing Machine. 2.0 SCOPE: This SOP is applicable for Operation and Cleaning of Ampoule Filling and Sealing Machine, Twelve Heads, in Production 3.0 RESPONSIBILITY: Officer Production 4.0 ACCOUNTABILITY: … Read more
sop for Fogging in Sterile and Non Sterile Area 1.0 OBJECTIVE: To lay down a procedure for Fogging in Sterile and Non Sterile Area. 2.0 SCOPE: This SOP is applicable for Fogging in Sterile and Non sterile Area using Fogging Machine 3.0 RESPONSIBILITY: Officer/Executive Production 4.0 ACCOUNTABILITY: Head Production 5.0 PROCEDURE: 5.1 … Read more
sop for for Filtration of Bulk Solution 1.0 OBJECTIVE: To lay down a procedure for Filtration of Bulk Solution. 2.0 SCOPE: This SOP is applicable for Filtration of Bulk Solution in Production Area 3.0 RESPONSIBILITY: Officer / Production Manager 4.0 ACCOUNTABILITY: Head Production 5.0 PROCEDURE: 5.1 Clean the Cartridge Filter Housing … Read more
sop for fumigation in production area 1.0 OBJECTIVE: To lay down a Procedure for Fumigation in Production Area. 2.0 SCOPE: This SOP is applicable for Fumigation in Production Area 3.0 RESPONSIBILITY: Officer / Executive – Production 4.0 ACCOUNTABILITY: Head – Production 5.0 PROCEDURE: 5.1 Fumigation should be carried out at the … Read more
sop for post cleaning after media fill 1.0 OBJECTIVE: To lay down a procedure for Post Cleaning after Media Fill of Production Line. 2.0 SCOPE: This SOP is applicable for Post Cleaning after Media Fill in Production Area 3.0 RESPONSIBILITY: Officer / Executive – Production Officer / Executive – QA Officer … Read more
sop for cip of mixing vessel mixing mobile vessel and holding vessel 1.0 OBJECTIVE: To lay down the procedure for Cleaning of Mixing Vessel/Holding Vessel, Cartridge Housing and Filter Housings and Pipe lines using CIP. 2.0 SCOPE: This SOP is applicable to Cleaning of Mixing Vessel/Holding Vessel, Cartridge Housing & Filter Housings and … Read more
sop for De-Bagging of Three Piece Vial Dropper Caps 1.0 OBJECTIVE: To lay down a procedure for De-Bagging of Three Piece Vials/Dropper/Caps. 2.0 SCOPE: This SOP is applicable for De-Bagging of Three Piece Vials/Dropper/Caps in Production area of Three Piece Line 3.0 RESPONSIBILITY: Officer/Executive – Production 4.0 ACCOUNTABILITY: Head –Production 5.0 PROCEDURE: … Read more
sop for calibration and verification of check weigher 1.0 OBJECTIVE: To lay down a procedure for Operation and Cleaning of Checkweigher. 2.0 SCOPE: This SOP is applicable for Operation and Cleaning of Checkweigher in Three Piece Line 3.0 RESPONSIBILITY: Officer/Executive – Production 4.0 ACCOUNTABILITY: Head – Production 5.0 PROCEDURE: 5.1 INSTRUCTIONS: 5.1.1 Check … Read more
sop for Batch number and Manufacturing and Expiry Date Coding System 1.0 PURPOSE To describe the unique Batch Number and Manufacturing and Expiry date coding system to be followed for the products manufactured. 2.0 SCOPE 2.1 This procedure applies to all products and batches manufactured 3.0 REFERENCE(S) 3.1 In- House 4.0 … Read more