Tag Archives: Srinagar

SOP For Design Qualification of Colloid Mill OBJECTIVE To design, engineer, and supply the Colloid Mill and to provide assurance that the machine is manufactured and it comply with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in …

SOP For Installation qualification of 300 L Gelatin Melting Reactor PURPOSE: To describe the Installation Qualification of 300 L Gelatin Melting Reactor its accessories and to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the …

SOP for Design Qualification of Blister Packing Machine (Model – BQS) OBJECTIVE To design, engineer, and supply the Blister Packing Machine  (Model: BQS) and to ensure that it complies with the Scope of Supply. To prove that each operation proceeds as per the design specification and the tolerances prescribed there …

SOP for Sampling of In-process blends, uncoated tablets, coated tablets and filled capsules OBJECTIVE : To provide a procedure for representative sampling of  In-process blends, uncoated tablets, coated tablets and filled capsules. RESPONSIBILITY : Officer – Quality Assurance. Head – Quality Assurance to ensure compliance. PROCEDURE : After receiving the …

Installation qualification of Blister Packing Machine (Hoonga) PURPOSE To describe the Installation Qualification procedure to be used during qualification of Blister Packing Machine (Hoonga), its accessories and to define the Specification of the system in order to Ensure that the equipment meets the specification as Design Qualification. Aid verification of …

SOP for Operational qualification protocol of Gelatin Melting Reactor PURPOSE: To describe the Operational Qualification of 300 L Gelatin Melting Reactor, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per user requirements. ensure that the equipment …

SOP for Operational Qualification of Capsule Printing Machine PURPOSE:  To describe the Operational Qualification of Capsule Printing Machine its accessories and to define the specification of the system in order to: ensure that the machine meets the Operational / Design limits as per user requirements ensure that the machine will …

SOP for Design Qualification of Capsule Printing machine OBJECTIVE To design, engineer, and supply the Capsule Printing Machine and to provide assurance that the machine is manufactured as per the URS and it comply with the Scope of Supply. To prove that each operation proceeds as per the design qualification …

SOP for Installation Qualification of Capsule Printing machine PURPOSE To describe the Installation Qualification of Capsule printing machine, its accessories and to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the installation as per equipment …

SOP FOR OPERATIONAL QUALIFICATION of Soft Gelatin Encapsulation System PURPOSE To describe the Operational Qualification of Arbes Encapsulation System (CAP-X-8) along with Tumble Dryer and Gravity Feed Pipes, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as …

SOP For Procedure for calibration of Autotitrator (METTLER TOLEDO) OBJECTIVE To lay down the procedure for Calibration of Autotitrator  (METTLER TOLEDO DL50). SCOPE This SOP shall be applicable for the Autotitrator (METTLER TOLEDO DL50). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. PROCEDURE FOR CLEANING Check that the power supply …

Procedure for calibration of the calculator OBJECTIVE To lay down the Procedure for Calibration of the calculator. SCOPE This SOP provides guidance to calibrate the calculators, which are used for simple and complex calculations of analysis in the quality control department. Scientific calculator Desktop calculator Calculator used in the computer …

Change Control Review SOP Change Control Review is the procedure for review and change control of formats originated through Standard Operating Procedures (SOPs), This procedure is applicable for review and changes control of formats in the instances, where only the respective format(s) required to be reviewed, with out revising the …

SOP For Calibration procedure for pH meter OBJECTIVE To describe the calibration procedure for   pH meter. SCOPE This SOP shall be applicable for the calibration procedure for pH meter RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control   Manager PROCEDURE Operate the Instrument as per procedure. Insert the pH electrode and temperature …

Change Control in Pharma Industries Change Control in Pharma Industries is a  procedure to ensure that no changes are made in any approved pharmaceutical product, manufacturing process, GMP-related equipment/facility/utility, computer system, Standard Operating  Procedures (SOPs), Standard  Cleaning  Procedures (SCPs), Master Production Records, specifications, standard test procedures, the vendor of raw …

HANDLING OF MARKET COMPLAINTS To provide the procedure for handling of market complaints and to ensure that all complaints related to drug products are recorded and investigated promptly with the aim of addressing them in a timely manner to satisfy the complainant, adhere to compliance requirements as well as to …

SOP For Control of Completed Batch Production OBJECTIVE : To provide a procedure for the proper control of completed Batch Production Records (BPR) after the release of finished drug products for distribution. RESPONSIBILITY : Officer – Quality Assurance. Officer – Documentation. Head of Quality Assurance Department to ensure compliance. PROCEDURE …

Review of Batch Production Records OBJECTIVE : To provide a procedure for the review of the Batch production records (BPR) before releasing drug products, in order to verify compliance with cGMP requirements and all established specifications and written procedures in the manufacturing of the product batch. RESPONSIBILITY :  Quality Assurance …

SOP For Release of Finished Products OBJECTIVE : To lay down the procedure for QA release of Finished Product for distribution. RESPONSIBILITY : Quality Assurance Officer. Head of Quality Assurance Department to ensure compliance. PROCEDURE : After receiving Finished Product Release Report (FRR)  (Annexure – 1) from Production Department, QA …

SOP For Process Area clearance during batch/product changeover OBJECTIVE : To provide a procedure for  Process area clearance during batch/product changeover. RESPONSIBILITY : Officer Quality Assurance for implementation Head of Quality Assurance Department to ensure compliance. PROCEDURE : Note: Type-A  Area clearance : During the batch changeover of the same …