Validation & Qualification
Factory Acceptance Test of Automatic Capsule Filling Machine Table of Contents System Information Protocol Details Protocol Approval from Customer Objective of this protocol Scope of this Protocol Definition of FAT and SAT Acceptance Criteria Responsibility Customer Requirements Performance Check Points & Testing Machine … Read more
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 of additional pilot laboratory batches of … Read more
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 the process can and cannot do under a given set … Read more
Checklist of Qualification and Control Documentation The FDA, as per existing cGMP regulations and considers process validation necessary because it makes good engineering sense. Subpart Subpart Section of CGMPs Qualification and control documentation A General provisions – B Organization and personnel Responsibilities of the quality control unit C Buildings and facilities Plant and facility installation and qualification … Read more
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 three ways of establishing quality … Read more
Design qualification pretreatment & purified water generation system OBJECTIVE AND SCOPE 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 … Read more
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 are responsible for this SAT … Read more
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 … Read more
FACILITY VALIDATION PROTOCOL TABLE OF CONTENTS SR. NO. CONTENTS PAGE NO. 1.0 APPROVAL 2.0 OBJECTIVE 3.0 SCOPE 4.0 RESPONSIBILITY 5.0 PROCEDURE 6.0 ACCEPTANCE CRITERIA 7.0 REQUALIFICATION CRITERIA 8.0 ABBREVIATIONS 9.0 REFERENCE 1.0 APPROVAL The FACILITY VALIDATION PROTOCOL for Production Granulation area has been initiated, Checked, Approved … Read more
Facility Validation in pharmaceutical Pharma Company Facility qualification (a part of validation that proves and documents that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results), and validation (establishing documented evidence that provides a high degree of assurance that the manufacturing processes, including buildings, systems, and equipment consistently … Read more