SOP

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SOP for cleaning of vial inspection machine

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 …

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SOP for cleaning of carton coding machine

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 …

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SOP for cleaning of vial sealing machine

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 …

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SOP for cleaning of vial washing machine

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 …

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VALIDATION OF HVAC SYSTEM

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SOP for operation of sticker labeling machine

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 …

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SOP for cleaning of vial labeling machine

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 …

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SOP for cleaning of sterilizing tunnel

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 …

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SOP for cleaning of bung processor cum steam sterilizer.

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 / …

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SOP on usage of Dynamic pass box

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. …

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SOP for cleaning of garment washing machine.

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 …

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SOP for operation of Air borne particle counter.

Objective: To lay down a procedure for operation of air borne particle counter. Scope This SOP is applicable for operation of air borne particle counter. Responsibility Officers or above (Production) shall be responsible for the operation of air borne particle counter. Accountability Production-Head shall be accountable for the compliance of …

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SOP for preparation of disinfectant solution

Objective: To lay down a procedure for preparation of disinfectant solution. Scope This SOP is applicable for preparation of disinfectant solution at dry powder Injectable facility. Responsibility Officers /above –(Production Injectable) is responsible for preparation of disinfectant solution. Accountability Production Head shall be responsible for the compliance of the SOP. …

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Production Question and Answer

1.Question: Definition of Good Manufacturing Practices (GMP) as per WHO ? Answer: WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.” GMP covers …

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MAINTENANCE OF VENTILATION SYSTEMS (EXHAUST)

OBJECTIVE            To lay down a procedure for Maintenance of Ventilation System SCOPE This SOP is applicable to Ventilation System (Exhaust).  RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE Weekly Maintenance Check condition of the belt for wear, tear and damage and replace if damaged and  clean the area with …

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MAINTENANCE OF VENTILATION SYSTEMS (SUPPLY)

OBJECTIVE            To lay down a procedure for Maintenance of Ventilation System SCOPE  This SOP is applicable to Ventilation System (Supply). block. RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE Weekly Maintenance Check condition of the belt for wear, tear and damage and replace if  damaged and  clean the area …

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CLEANING OF WATER OVER HEAD TANKS & SUMPS

CLEANING OF WATER OVER HEAD TANKS & SUMPS OBJECTIVE                                               To lay down a procedure for Cleaning of Water Over Head Tanks and Sumps SCOPE  This SOP is applicable to Water Over Head Tanks and Sumps. RESPONSIBILITY             Technical Supervisor / Engineer ACCOUNTABILITY                     Sr.Executive / Manager PROCEDURE Obtain work permit for carrying …

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MAINTENANCE OF DEHUMIDIFIERS, BRY-AIR MAKE, MVB MODEL

OBJECTIVE                                               To lay down a procedure for Maintenance of Dehumidifier SCOPE This SOP is applicable to all Dehumidifiers. RESPONSIBILITY             Technical Supervisor / Engineer ACCOUNTABILITY                     Sr.Executive / Manager PROCEDURE Daily Maintenance Check and ensure no unusual noise form the Actuator motor, Process air & Reactivation motor. Ensure the motor should be …

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Preparation, Approval, Review and Control of Standard Operating Procedures

OBJECTIVE:     To lay down the procedure for the preparation, approval, review and control of Standard Operating Procedures. RESPONSIBILITY:    All the personnel of  all department to be familiar with this Standard Operating Procedure (SOP). The approving authorities to ensure compliance to the preparation, approval and Review procedure. Head – QA or his …

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MAINTENANCE OF SCREW CHILLER MAKE: YORK

OBJECTIVE                                               To lay down a procedure for Maintenance of Screw Chiller SCOPE This SOP is applicable to Screw Chiller. RESPONSIBILITY             Technical Supervisor / Engineer ACCOUNTABILITY                     Sr.Executive / Manager PROCEDURE Daily Maintenance  Check and ensure oil level as per the mark …

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