Objective: To lay down a procedure for cleaning during media fill trial and decontamination after completion of media fill trials. Scope: This SOP describes the procedure for cleaning during media fill trials and decontamination after completion of media fills trials. Responsibility: Production Officers / Executive. Accountability: Production Head shall be accountable for the compliance of…
Upcoming results from late-stage data will have major impact on sector By CHARLEY GRANT Updated Nov. 22, 2016 5:06 p.m. ET After a year of drama for the health-care industry, ranging from the EpiPen pricing scandal to the collapse of Valeant Pharmaceuticals International and Theranos to the unknown future of Obamacare to a series of mergers,…
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Objective: To lay down a procedure for cleaning and sanitization of controlled area. Scope: This SOP is applicable for cleaning and sanitization of controlled area. Responsibility: Production Officer / Executive. Accountability: Production Head shall be accountable for compliance of SOP. Abbreviations SOP : Standard Operating Procedure. S.S. : Stainless Steel Procedure: Following are the areas…
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Objective: To lay down a procedure on Batch Preparation of vial filling process. Scope This SOP is applicable for batch preparation of vial filling process.. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. RM : Raw Material PM : Packing material…
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Objective To lay down the procedure of operation and cleaning of Pneumatic Lifting Table & visual Inspection machine. Scope This SOP is applicable for the operation and cleaning of Pneumatic Lifting Table & Visual Inspection used in the vial decartoning room of the sterile Injectable facility. Responsibility Production officer / Executive. Accountability Production Head shall…
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SOP for cleaning of strapping machineObjective: To lay down a procedure for cleaning of strapping machine. Scope This SOP is applicable for cleaning of Strapping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. Procedure The cleaning of Strapping machine is to be done after day’s production is…
Objective To lay down a procedure for cleaning of BOPP taping machine. Scope This SOP is applicable for cleaning of BOPP taping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. BOPP : Biaxial Oriented Polypropylene IPA : Isopropyl Alcohol Procedure The cleaning of BOPP taping machine is…
Objective: To lay down a procedure for cleaning of Ink Jet printing machine. Scope This SOP is applicable for the cleaning Ink jet printing machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. Cleaning Procedure Press “ON/OFF” switch and wait for two minutes. Image 9030 will be display…
Objective: To lay down a procedure for cleaning of laminar air flow units. Scope: This SOP is applicable for cleaning of laminar air flow units of Dry Powder Injectable facility. Responsibility Officers or above – Production. Accountability Production Head Shall be responsible for the implementation and compliance of the SOP. Abbreviations LAF : Laminar Air…
Objective: To lay down a procedure for cleaning of vial inspection machine. Scope This SOP is applicable for cleaning of vial inspection machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure Procedure Daily cleaning The cleaning is to be done after the days work is over or whenever…
Objective: To lay down a procedure for cleaning of carton coding machine. Scope This SOP is applicable for cleaning of carton coding machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. IPA : Isopropyl Alcohol Procedure Check that there are no coding stereos of the previous batch before…
Objective: To lay down a procedure for cleaning of vial sealing machine. Scope This SOP is applicable on procedure for cleaning of vial sealing machine for Production dry powder Injection facility. Responsibility Production Officers /Executive Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. No. : Number…
Objective: To lay down a procedure for cleaning of vial washing machine. Scope This SOP is applicable for cleaning of vial washing machine. Responsibility Officers – Production. Accountability Production Head. Procedure The cleaning is done after the day’s work is over or whenever necessary. Ensure that the left over vials are removed from the machine….
VALIDATION OF HVAC SYSTEM INSTALLATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM TABLE OF CONTENTS Sr. No Description Page No. 1 Objective 2 System / Equipment Description 3 Responsibility 4 Execution Team 5 Installation Verification 6 Installation Check 7 Documentation Requirement 8 Deviation Report 9 Installation Qualification Summary & Conclusion 10 Abbreviations 11…
Objective: To lay down a procedure for operation of labeling machine of pharmaceutical company. Scope: This SOP is applicable for sticker labeling machine. Responsibility: Production operator / Technician – responsible for operation of machine. Production officer / Executive – to ensure that operation of the machine is carried out as per SOP. Accountability: Production Head…
Objective: To lay down a procedure for cleaning of vial labeling machine. Scope This SOP is applicable for the cleaning of vial labeling machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. Cleaning Procedure At the end of the shift /batch change over of same product Switch off…
Objective: To lay down a procedure for Cleaning of sterilizing tunnel. Scope This SOP is applicable for Cleaning of sterilizing tunnel for Production dry powder Injection facility. Production Officers / Executive. Responsibility Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. WFI : Water for Injection. S.S….
Objective: To lay down a procedure for cleaning of Bung processor cum steam sterilizer. Scope: This SOP is applicable for cleaning of Bung Processor Cum Steam Sterilizer for Production dry powder Injection. Responsibility: Production operator / technician – responsible for cleaning of bung processor cum steam sterilizer. Production officer / Executive – to ensure that…
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Objective: To lay down a procedure on usage of Dynamic pass box. Scope This SOP is applicable for usage of Dynamic pass box ID.No PIDPB-01, PIDPB-02, PIDPB-03 and PIDPB-04. Responsibility Production Officer / Executive. Accountability Production Head shall be accountable for compliance of SOP. Abbreviations SOP : Standard Operating Procedure. IPA : Isopropyl alcohol IRM…
Objective: To lay down the procedure for cleaning of garments washing machine. Scope This SOP is applicable for cleaning of garments washing machine. Responsibility Production operator / technician – responsible for cleaning of garment washing Production officer / Executive – to ensure that cleaning of garment washing machine is carried out as per SOP. Accountability…
