Tag Archives: SRI JAYAWARDENEPURA KOTTE

SOP for delabelling and repacking of vials Objective: To lay down a procedure for Delabelling and Repacking of vials. Scope This SOP is applicable on procedure for Delabelling and Repacking of vials for Production dry powder Injection facility. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for …

SOP for cleaning of vial filling machine and its parts Objective To lay down a procedure for cleaning of vial filling machine and its parts. Scope This SOP is applicable for cleaning of vial filling machine and its parts for Production dry powder Injection facility. Responsibility Production Officers / Executive. …

SOP on cleaning of Liquid filling machine (Watson Marlon ) Objective: To lay down the procedure for cleaning of liquid filling machine (Watson Marlon). Scope This SOP is applicable for the procedure of cleaning of liquid filling machine shall be accountable for the compliance of SOP. Responsibility Production Officers / …

SOP for operation of sticker labeling machine (Maharshi) Objective: To lay down a procedure for operation of sticker labeling machine. Scope: This SOP is applicable for sticker labeling machine. Responsibility: Production operator/Technician- responsible for operation of sticker labeling machine. Production officer/ Executive – to ensure that operation of sticker labeling …

SOP for operation of shrink wrapping machine Objective: To lay down a procedure for operation of shrink wrapping machine. Scope: This SOP is applicable for shrink wrapping machine. Responsibility: Officers or above – Production. Accountability: Production Head. Abbreviations SOP : Standard Operating Procedure. MASTER FORMULA OF MEBENDAZOLE TABLETS Procedure: Pre-startup: …

SOP on cleaning of shrink wrapping machine Objective: To lay down a procedure for cleaning of shrink wrapping machine. Scope This SOP is applicable for cleaning of shrink wrapping machine in production area. Responsibility Production operator / technician – responsible for cleaning of machine. Production officer / Executive – to …

SOP for cleaning of sticker labeling machine (Maharshi) Objective: To lay down a procedure for cleaning of sticker labeling machine. Scope This SOP is applicable for the cleaning of sticker labeling machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. MASTER FORMULA OF …

SOP for operation & cleaning of electronic balance 50Kgs (lakshmi Samson) Objective: To lay down a procedure for operation & cleaning of electronic balance 50kgs (Make Lakshmi Samson) Scope This SOP is applicable for operation & cleaning of electronic balance 50kgs (Make Lakshmi Samson). Responsibility Production officer/ Executive Accountability Production …

SOP for operation & cleaning of electronic balance 3 Kgs (lakshmi Samson) Objective: To lay down a procedure for operation & cleaning of electronic balance 3 kgs (Make Lakshmi Samson) Scope This SOP is applicable for operation & cleaning of electronic balance 3 kgs (Make Lakshmi Samson). Responsibility Production officer/ …

SOP on cleaning of Aspirator assembly and disposal of waste raw material collected during filling operation. Objective  To lay down the procedure for cleaning of aspirator assembly and disposal of waste raw material collected during filling operation. Scope This SOP is applicable for cleaning of aspirator assembly and disposal of …

SOP for cleaning of PVC flaps of Laminar Air Flow To lay down a procedure for cleaning of PVC flaps of Laminar Air Flow. Objective: Scope This SOP is applicable for cleaning of PVC flaps of Laminar Air Flow. Responsibility Production operator / Technician – responsible for operation of cleaning …

PURPOSE: To describe the Operational Qualification of Vertical Laminar Reverse flow Containment Station, 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 will be operationally qualified in accordance with current …

PURPOSE To describe the Installation Qualification of Vertical Laminar Reverse Flow Containment Station 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 general arrangement drawing. Ensure that the system …

PURPOSE: To describe the Operational Qualification of Medicament Preparation Vessel, 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 shall be operationally qualified in accordance with current Good Manufacturing Practices. …

PURPOSE: To describe the Installation Qualification of Raw Gelatin Storage Vessel 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 general arrangement Drawing. Ensure that the system …

PURPOSE To describe the Installation Qualification procedure to be used during qualification of Aluminium Strip Defoiler to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Ensure that the system installation meets acceptance criteria Ensure that the equipments will …

Deviation Handling and Quality Risk Management This  guidance Based on WHO recommended requirements, these documents provide further explanations with examples in order to facilitate implementation. Deviation handling Quality Risk Management was mainly designed to be used prospectively when manufacturing operations are defined and validated. The potential deviations are identified and …

Procedure for Operation & Cleaning of Mass Mixer 1.0       OBJECTIVE:             To Lay Down the Procedure for Operation & Cleaning of Mass Mixer. 2.0       SCOPE:             This SOP is applicable for production Department for Operation & Cleaning of Mass Mixer            3.0       RESPONSIBILITY: 3.1       Officer production & …

Operation & Cleaning of Laser Printing Machine 1.0       OBJECTIVE:             To Lay Down the  Procedure for Operation & Cleaning of Laser Printing Machine. 2.0       SCOPE: This SOP is applicable for production Department for Operation & Cleaning of Laser Printing Machine   3.0       RESPONSIBILITY: 3.1       Officer production …

Operation & Cleaning of Induction Sealing Machine 1      OBJECTIVE: To Lay Down the  Procedure for Operation & Cleaning of Induction Sealing Machine. 2.0       SCOPE: This SOP is applicable for production  Department for Operation & Cleaning of Induction Sealing Machine   3.0       RESPONSIBILITY: 3.1       Officer production …