sop for for Spillage Handling in parenteral area 1.0 OBJECTIVE: 1.1 To lay down the procedure for Spillage Handling. 2.0 SCOPE: 2.1 This SOP is applicable for Handling of Spillage of all Substances and Products in Injection (Parenteral) Area 3.0 RESPONSIBILITY: 3.1 Officer / Executive – Production 4.0 ACCOUNTABILITY: 4.1 Head – Production … Read more
sop for calibration of vessels with dipstick 1.0 OBJECTIVE: 1.1 To lay down a Procedure for calibration of vessels with dipstick. 2.0 SCOPE: 2.1 This SOP is applicable to calibration of vessels with dipstick in Injection Parenteral Departments 3.0 RESPONSIBILITY: 3.1 Officer /Executive Production 3.2 Officer /Executive QA 4.0 ACCOUNTABILITY: 4.1 Head Production … Read more
sop for Cleaning of Bins and Containers 1.0 OBJECTIVE: 1.1 To lay down a Procedure for Cleaning of Bins and Containers. 2.0 SCOPE: 2.1 This SOP is applicable for Cleaning of Bins and Containers in Injection 3.0 RESPONSIBILITY: 3.1 Officer / Executive Production 4.0 ACCOUNTABILITY: 4.1 Head – Production 5.0 PROCEDURE: 5.1 Transfer … Read more
cip of mixing 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 and Filter Housings and Pipe Lines using CIP … Read more
sop for batch manufacturing 1.0 OBJECTIVE: To lay down a procedure for Batch Manufacturing. 2.0 SCOPE: This SOP is applicable for Batch Manufacturing in production area 3.0 RESPONSIBILITY: Officer/Executive Production 4.0 ACCOUNTABILITY: Head Production 5.0 PROCEDURE: 5.1 PRECAUTIONS: 5.1.1 Always follow manufacturing instructions according to the respective BMR. 5.1.2 Prepare One Batch … Read more
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