Tag Archives: Jammu

PILOT SCALE-UP AND PROCESS VALIDATION The development of product prior to the preparation of the first pilot-production batch. The development activities are listed as follows: 1. Formulation design, selection, and optimization 2. Preparation of the first pilot-laboratory batch 3. Conduct initial accelerated stability testing 4. If the formulation is deemed stable, preparation …

WHAT IS PROCESS VALIDATION? The process validation is derived from the fact that the specific exercise of process validation should never be designed to fail. Failure in carrying out the process validation assignment is often the result of incomplete or faulty understanding of the process’s capability, in other words, what …

Master Plan or Protocol for Process Capability Design and Testing Objective Process capability design and testing Types of process Batch, intermittent, continuous Typical processes Chemical, pharmaceutical, biochemical Process definition Flow diagram, in-process, finished product Definition of process output Potency, yield, physical parameters Definition of test methods Instrumentation, procedures, precision, and …

Checklist of Qualification and Control Documentation The FDA, as per existing cGMP regulations and considers process validation necessary because it makes good engineering sense. Organization and personnel – Responsibilities of the quality control unit Buildings and facilities : Plant and facility installation and qualification Maintenance and sanitation Microbial and pest control Equipment …

STATISTICAL PROCESS CONTROL AND PROCESS VALIDATION IN PHARMACEUTICALS Statistical process control (SPC), also called statistical quality control and process validation (PV) SPC comprises the various mathematical tools (histogram, scatter diagram run chart, and control chart) used to monitor a manufacturing process and to keep it within in-process and final product specification limits. There are …

  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 …

  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 …

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 …

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 …

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 …

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 is applicable to multi column water. RESPONSIBILITES Inspection Customer or their authorized representatives …

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 …

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 …

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 …

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 …

Dust control during AHU design in Pharma Company Dust control in Pharma Company in measure challenge Wherever possible, dust or vapour contamination should be removed at source. Point-of-use extraction, i.e. as close as possible to the point where the dust is generated, should be employed. Spot ventilation or capture hoods may …

SOP For QUALITY BY DESIGN (QBD) IN PHAARMACEUTICAL PRODUCT INTRODUCTION: The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design (QbD) is emerging …

FACILITY VALIDATION PROTOCOL To ensure that the Facility installed, for the Production Granulation area conforms with the predetermined acceptance criteria. SCOPE OF FACILITY VALIDATION PROTOCOL: – To perform the Facility validation for Production Granulation  area. RESPONSIBILITY: – Validation Executive Engineering Executive Production Executive PROCEDURE: – Check the facility as per …

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 …

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 …