HPLC Columns management
HPLC Columns management HPLC Privileges on application software waters
Author: Pharma Editor
SOP on Procedure for operation of analytical balance
OBJECTIVE To lay down a procedure for operating and cleaning of analytical balance) SCOPE This SOP shall provide the Operating procedure of analytical balance of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE Description of balance: XS 204 DR is analytical class balance with a touch screen display terminal having…
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SOP on Operating procedure for tap density apparatus make : electrolab
OBJECTIVE To lay down the procedure for Operation of Tap density apparatus, Make Electro lab. SCOPE This SOP shall provide the Operating procedure of Tap density apparatus of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE Before starting the operation Check for the area cleanliness and instrument cleanliness. Connect the…
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SOP on Operating procedure for sieve shaker in quality control
SOP on Operating procedure for sieve shaker in quality control To lay down the procedure for the Operation of the Mechanical Sieve Shaker, Make an Electro Lab. SCOPE OF SOP This SOP shall provide the Operating procedure of Mechanical Sieve Shaker of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control. ACCOUNTABILITY Head QC/QA. PROCEDURE…
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Procedure for calibration of Instruments/ Equipments.Quality Assurance
OBJECTIVE : To lay down policy for calibration of Instruments/Equipments. RESPONSIBILITY : Personnel of the concerned department to calibrate the instrument/equipment and investigate the failure, if any. Heads of the concerned department to ensure compliance. Procedure : All the instruments associated with the processing and testing of materials and products shall be calibrated. There shall…
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Operation qualification protocol for air handling unit & air distribution system
Operation qualification protocol for air handling unit & air distribution system Purpose: The purpose of this protocol is: Verifying the operational attributes of the Heating Ventilation and Air Conditioning system is critical to serve the intended purpose. To establish the suitability of the draft SOP prepared for the operation of System. To document the observations…
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Installation qualification protocol for air handling unit and air distribution system
Installation qualification protocol for air handling unit and air distribution system OBJECTIVE The objective of this protocol is to provide an outline for the inspection of static attributes, written procedure and guidelines and respective acceptance criteria for the Installation and Operational Qualification of Air handling unit . The Air-Handling unit caters to:- AREA DETAILS – Name…
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SOP on cleaning of production area footwears.
Objective The SOP describes cleaning procedure for footwear used in production area. Scope This SOP is applicable for the cleaning procedure for footwear used in production area. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations IPA : Isopropyl alcohol Description Cleaning of the section footwears is…
SOP for operation, cleaning and maintenance of Fogger.
Objective To lay down the procedure for operation, cleaning and maintenance of Fogger. Scope This SOP is applicable for the operation, cleaning and maintenance of Fogger used in the Aseptic area of Sterile Injectable Facility. Responsibility Production officer / Executive. Accountability Production Head shall be accountable for compliance of SOP. Abbreviations SOP : Standard Operating…
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SOP on sterilization of vial filling and bunging machine parts
Objective: To lay down a procedure for sterilization of vial filling and bunging machine parts. Scope This SOP is applicable for sterilization of vial filling and bunging machine parts. Responsibility Production Officers/ Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. Procedure Controlled Area Operation. Load…
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SOP for Operation of Vacuum Leak Test
Objective: To lay down a procedure for operation of vacuum leak test Scope: This SOP is applicable for operation of vacuum leak test. Responsibility: Production Officers / Executive. Accountability: Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure MMI : Man Machine Interface NST : Non sterile side…
SOP on cleaning of Pre-filters of LAF Unit, Sterile Garment cubicle, Dynamic pass box.
Objective: To lay down a procedure for cleaning of the pre-filters of LAF Unit, garment cubicle, dynamic pass box. Scope This SOP is applicable for cleaning of pre-filters of LAF Unit, garment cubicle, dynamic pass box. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP :…
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SOP for disposal of rejected primary and secondary packing materials
Objective: To lay down a procedure for Disposal of rejected primary & secondary packing materials. Scope This SOP is applicable on procedure for Disposal of rejected primary & secondary packing materials for Production dry powder Injection facility. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. WFI : Water…
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SOP On Installation, Operational and Performance qualification of Equipment
OBJECTIVE : To lay down the procedure for Installation, Operation and Performance qualification of Equipment. RESPONSIBILITY : Validation team comprising of representatives from functional department, Engineering department and Quality Assurance department. Head – QA, Head – Engineering and Head of the concerned department to ensure compliance. PROCEDURE Any equipment or instrument purchased shall…
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Preparation, Approval and Control of Standard Cleaning Procedures for equipments
Preparation, Approval and Control of Standard Cleaning Procedures for equipments OBJECTIVE : To lay down the guidelines for the preparation, approval and control of Standard Cleaning Procedure (SCP) for all the applicable equipments. RESPONSIBILITY : All the personnel involved in the cleaning of equipments. Heads of concerned departments to ensure compliance. PROCEDURE Every equipment …
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SOP on Assembly of cartridge filter in housing.
Objective: To lay down a procedure on assembly of cartridge filter in housing. Scope This SOP is applicable for assembly of cartridge filter in housing. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. WFI : Water For Injection Procedure Close the valve of compressed air or Nitrogen Line…
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SOP for collection and disposal of waste & rejected material from plant
Objective: To lay down a procedure for collection and disposal of waste & rejected material from plant. Scope: This SOP is applicable for collection and disposal of waste & rejected material from plant. Responsibility: Officers or above – Production. Accountability: Production Head. Abbreviations SOP : Standard Operating Procedure. S.S. : Stainless Steel WFI : Water…
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SOP for operation and cleaning of Sterile garment cubicle
Objective: To lay down a procedure on operation and cleaning of sterile garment cubicle. Scope This SOP is applicable for the operation and cleaning of sterile garment cubicle. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. LAF : Laminar air flow U.V. : Ultra violet Procedure Operation: Sterile…
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SOP for final packing of products.
Objective: To lay down a procedure for final packing of products Scope This SOP is applicable for final packing of products for Production dry powder Injection facility. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. BOPP : Biaxial Oriented Poly Propylene. MFG. : Manufacturing EXP. : Expiry Procedure…
SOP on cleaning and sanitization of goggles used in aseptic area
Objective: To lay down a procedure for cleaning and sanitization of goggles used in aseptic area. Scope This SOP is applicable for procedure of cleaning and sanitization of goggles used in aseptic area. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure….
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