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
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 In Process Checks 1.0 PURPOSE To define a procedure for in process checks to be performed during manufacturing and packing of pharmaceutical products to ensure that all the critical parameters are within the specified limits standards. or 2.0 SCOPE 2.1 This procedure applies for in process checks to be performed during … 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 Transport Validation 1.0 PURPOSE: 1.1 To lay down a procedure for transit study to ensure that the high level of product quality is maintained throughout the distribution network. 2. SCOPE: This procedure is applicable to products manufactured and dispatched to various … Read more