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 …
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SOP for cleaning of inkjet printing machine
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. …
Read More »SOP for cleaning of laminar air flow units.
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. …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »VALIDATION OF HVAC SYSTEM
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 …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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 / …
Read More »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. …
Read More »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 …
Read More »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 …
Read More »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. …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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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