Tag Archives: Repton

In-process checks during Packaging Operation of tablets and capsules

OBJECTIVE : To lay down the procedure for in-process checks during the packaging operation of tablets and capsules. RESPONSIBILITY : Officer-Production Packaging. Head of Production Department. Officer-Quality Assurance Head of Quality Assurance Department to ensure compliance. PROCEDURE Inspection of Packaging Materials : The production Officer and QA-Officer shall check that …

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Installation qualification for WFI generation plant

Installation qualification for WFI generation plant  RESPONSIBILITES Inspection  Customer or their authorized representatives are responsible for this SAT document. All documents shall be checked and approved by QA or their authorized representatives. Production personal will perform this test. OBJECTIVE To confirm, by physical inspection and testing, that the fabrication and …

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SOP on Procedure for operation of HPLC (waters-alliance)

SOP on Procedure for the operation of HPLC (waters-alliance) In the pharmaceutical industry, where precision and accuracy are non-negotiable, High-Performance Liquid Chromatography stands as a stalwart technology. From drug development to quality control and regulatory compliance, HPLC plays a vital role in ensuring the safety, efficacy, and consistency of pharmaceutical …

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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 …

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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 …

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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 …

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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 …

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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: To verify the operational attributes of the Heating Ventilation and Air Conditioning system, critical to serve the intended purpose. To establish the suitability of the draft SOP prepared for the operation of …

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Installation qualification protocol for air handling unit & air distribution system

Installation qualification protocol for air handling unit & 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 …

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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 …

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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. …

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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. …

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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 …

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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 …

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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 …

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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 …

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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 …

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Blend uniformity

BUA is an in-process test that is useful for ensuring the adequacy of the mixing of active pharmaceutical ingredients (APIs) with other components of the drug product. Definition Blend Uniformity (in accordance with FDA Guidance for Industry, ANDAs: Blend Uniformity Analysis, 1999) In-Process Control Scope BUA or homogeneity testing can …

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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 …

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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. : …

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