Author: Pharma Editor

Procedure for operation of Autotitrator (METTLER TOLEDO). Quality assurance

February 15, 2019February 2, 2023 Pharma Editor

Procedure for operation of Autotitrator (METTLER TOLEDO). Quality assurance OBJECTIVE To lay down the procedure for operation of AUTO TITRATOR (METTLER TOLEDO DL50) SCOPE This procedure is applicable to Autotitrator (METTLER TOLEDO DL50). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched ‘…

Quality Control

PROCEDURE FOR OPERATION OF HUMIDITY CONTROL OVEN (NEWTRONIC)

February 8, 2019February 2, 2023 Pharma Editor

PROCEDURE FOR OPERATION OF HUMIDITY CONTROL OVEN (NEWTRONIC). Quality assurance OBJECTIVE To lay down the procedure for operation of Humidity control oven. Model : NEC 228R 10S SCOPE This SOP shall be applicable for the operation of Newtronic make Humidity control oven (30°C/65%RH) &. (40°C/75%RH) RESPONSIBILITY QA Officer / Executive ACCOUNTABILITY Assistant Manager Quality Assurance…

Quality Control

SOP on operation and cleaning of analytical balance used in aseptic area (Sartorious).

March 26, 2018February 2, 2023 Pharma Editor

SOP on operation and cleaning of analytical balance used in aseptic area (Sartorious) Objective: To lay down a procedure for operation and cleaning of analytical balance used in the aseptic area (Make: Sartorious). Scope The SOP describes the procedure for operation and cleaning of analytical balance used in the aseptic area (Make: Sartorious). Responsibility Officers…

Production

Procedure for calibration of balance XS 204 DR.

March 21, 2018February 2, 2023 Pharma Editor

To lay down a procedure for calibration of Weighing Balance XS – 204 DR SCOPE This Standard Calibration Procedure (SOP) is applicable in quality control area. RESPONSIBILITY Quality Control Officer/ Executive ACCOUNTABILITY Head –Quality Assurance PROCEDURE PRE STARTUP Check the cleaning of the weighing balance especially pan & display terminal. Check the power supply…

Quality Control

Operational Qualification of Ointment Manufacturing Vessel

May 13, 2017February 2, 2023 Pharma Editor

Operational Qualification of Ointment Manufacturing Vessel PURPOSE: To describe the Operational Qualification of Ointment Manufacturing Vessel, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per user requirements. ensure that the equipment shall be operationally qualified in accordance with current Good Manufacturing…

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Installation Qualification of Ointment Manufacturing Vessel

May 13, 2017February 2, 2023 Pharma Editor

Installation Qualification of Ointment Manufacturing VesselPURPOSE To describe the Installation Qualification procedure to be used during qualification of Ointment Manufacturing Vessel, its accessories and to define the Specification of the system in order to Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the installation as per equipment general…

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Design Qualification of Ointment Manufacturing Vessel

May 13, 2017February 2, 2023 Pharma Editor

Design Qualification of Ointment Manufacturing VesselOBJECTIVE To design, engineer, and supply the Ointment Manufacturing Vessel and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same…

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Design Qualification of Blister Packing Machine (Model – BQS)

May 10, 2017February 2, 2023 Pharma Editor

DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS) TABLE OF CONTENT Objective Scope Responsibility Machine description Technical specification Technical specifications and make of sub-components/ bought out items. Details of Utilities Identification of components for calibration Material of construction of all components Safety features and alarms FAT procedure Change control procedure Qualification Document report approval Appendix…

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SOP on Procedure for storage of sterilized rubber stoppers in aseptic area .

May 10, 2017February 2, 2023 Pharma Editor

Objective To lay down the procedure for storage of sterilized rubber stoppers in aseptic area. Scope This SOP is applicable for storage procedure of sterilized rubber stoppers in aseptic area Production dry powder Injectable facility. Responsibility Production officer / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard…

Production

Purified Water -Design qualification pretreatment, generation system

May 4, 2017June 24, 2024 Pharma Editor

Purified Water -Design qualification pretreatment, generation system To design the equipment / instrument in conjunction with the design data in order to provide basis for vendor, manufacturer & / or the design engineer for designing the system when the project begins. To prepare detailed specification for all major components of Equipment / instrument to ensure…

Validation & Qualification

Operational qualification for WFI generation plant

May 4, 2017June 24, 2024 Pharma Editor

Operational qualification for WFI generation plant OBJECTIVE To establish documentary evidence to demonstrate the WS system is qualified for correct operation as per guidelines outlined in this protocol & operational manual SCOPE OF THIS DOCUMENT This protocol applies to multi-column water. RESPONSIBILITIES Inspection Customer or their authorized representatives are responsible for this SAT document. All…

Validation & Qualification

Design Qualification of Vertical Laminar Reverse Flow Powder Containment Station

May 2, 2017February 3, 2023 Pharma Editor

OBJECTIVE To design, engineer and supply the Vertical Laminar Reverse Flow Powder Containment Station to provide assurance that the machine is manufactured as per the URS and it complies with the Scope of Supply. To prove that each operation proceeds as per the design specification and the tolerances prescribed there in the document are the…

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Installation Qualification of Medicament Preparation Vessel

May 1, 2017February 3, 2023 Pharma Editor

PURPOSE: To describe the Installation Qualification of Medicament Preparation Vessel its accessories and to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the installation as per equipment general arrangement Drawing. Ensure that the system installation meets acceptance criteria. Ensure that…

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Design Qualification of Medicament Preparation Vessel

April 28, 2017June 24, 2024 Pharma Editor

Design Qualification of Medicament Preparation Vessel OBJECTIVE: To design, engineer, and supply the Medicament Preparation Vessel and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same…

Validation & Qualification

Operational Qualification of Aluminium Strip Defoiler

April 28, 2017February 3, 2023 Pharma Editor

PURPOSE To describe the Operational Qualification of Aluminium Strip Defoiler and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per user requirements. ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices. SCOPE The scope of this document applies…

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Preparation, hahdling, storage and discard of mobile phases

April 27, 2017February 3, 2023 Pharma Editor

Preparation, hahdling, storage and discard of mobile phases OBJECTIVE To lay down a procedure for the preparation , handling , storage and discard of mobile phases. SCOPE This SOP shall be applicable for preparation , handling , storage and discard of mobile phases. RESPONSIBILITY Executive/Officer – Quality control ACCOUNTABILITY Head – Quality Assurance Procedure for…

Quality Control

SOP Operational Qualification of Raw Gelatin Storage Vessel

March 8, 2017February 3, 2023 Pharma Editor

SOP Operational Qualification of Raw Gelatin Storage Vessel PURPOSE: To describe the Operational Qualification of Raw Gelatin Storage Vessel, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per user requirements. ensure that the equipment shall be operationally qualified in accordance with…

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SOP For Design Qualification of Raw Gelatin Storage Vessel

March 8, 2017February 3, 2023 Pharma Editor

SOP For Design Qualification of Raw Gelatin Storage Vessel OBJECTIVE: To design, engineer and supply the Raw Gelatin Storage Vessel and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the…

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SOP For Installation Qualification of Encapsulation Machine

March 8, 2017February 3, 2023 Pharma Editor

SOP For Installation Qualification of Encapsulation Machine PURPOSE To describe the Installation Qualification of Encapsulation Machine along with Tumble Dryer and Gravity Feed Pipes, its accessories and to define the Specification of the system in order to: ensure that the equipment meets the specification as Design Qualification aid verification of the installation as per equipment…

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SOP for Operational qualification protocol of Blister Packing Machine (BQS)

March 5, 2017February 3, 2023 Pharma Editor

SOP for Operational qualification protocol of Blister Packing Machine (BQS) PURPOSE To describe the Operational Qualification procedure to be used during qualification of Blister Packing Machine (BQS), its accessories and to define the specification of the sytem in order to: Ensure that the equipment meets the Operational/Design limits as per user requirements Ensure that the…

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