sop for Fogging in Aseptic and Non Aseptic Area 1.0 OBJECTIVE: 1.1 To lay down a procedure for Fogging in Aseptic and Non Aseptic Area. 2.0 SCOPE: 2.1 This SOP is applicable for Fogging in Aseptic and Non Aseptic Area in Injection Parenteral 3.0 RESPONSIBILITY: 3.1 Officer / Executive Production 4.0 ACCOUNTABILITY: 4.1 Head … Read more
Receipt of Batch from Production to Packing Department 1.0 OBJECTIVE: 1.1 To lay down a procedure for Receipt of Batch from Production to Packing Department. 2.0 SCOPE: 2.1 This SOP is applicable for Receipt of Batch from Production to Packing Department in Injection Parenteral 3.0 RESPONSIBILITY: 3.1 Officer / Executive Production 4.0 ACCOUNTABILITY: 4.1 Head … Read more
Online Rejection in parenteral 1.0 OBJECTIVE: 1.1 To lay down the Procedure for Online Rejection in parenteral 2.0 SCOPE: 2.1 This SOP is applicable for Online Rejection at area 3.0 RESPONSIBILITY: 3.1 Officer / Executive – Concerned Department 4.0 ACCOUNTABILITY: 4.1 Head – Production 5.0 PROCEDURE: 5.1 Officer /Supervisor of concerned department shall … Read more
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