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 Inward Outward register in Production 1.0 OBJECTIVE: To lay down the procedure Making entries in inward and Outward register in production. 2.0 SCOPE: This procedure is applicable for Making entries in inward and Outward register in production. 3.0 RESPONSIBILITY: Officer /Executive/Assistant Manager Head Production: To ensure execution and compliance. Head … 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 for De Cartoning of Ampoules 1.0 OBJECTIVE: To lay down a Procedure for De-Cartoning of Ampoules. 2.0 SCOPE: This SOP is applicable for De-Cartoning of Ampoules in Production area 3.0 RESPONSIBILITY: Officer / Executive – Production 4.0 ACCOUNTABILITY: Head – Production 5.0 PROCEDURE: 5.1 PREREQUISITES: 5.1.1 If any shipper observed with … 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 Preparation of Master Lists 1.0 PURPOSE To provide the procedure for preparation of master list. 2.0 SCOPE 2.1 This SOP is applicable for preparation of master list for Standard operating Procedure, Equipment’s, Accessories, Instruments, Departmental Staff, FDA Approved Competent Technical staff, Product, Drain Points, Sampling Points of Potable Water, Purified Water, … Read more
sop for Verification of Steroids Inactivation 1.0 OBJECTIVE: To lay down a Procedure for Verification of Steroids Inactivation. 2.0 SCOPE: This SOP is applicable for Procedure for Verification of Steroids Inactivation 3.0 RESPONSIBILITY: Quality Control (Officer/ Executive): Preparation of this SOP. Quality Assurance (Officer/ Executive): Issuance & retrieval of this SOP. 4.0 … Read more