Design Qualification [DQ] Documented evidence that, for example, the premises, supporting systems, utilities or equipment have been designed for their intended purposes and in accordance with the requirements of good manufacturing practices. The premises, supporting systems, utilities or equipment shall be designed according to User User Requirements Specification (URS) Design Reviews / Qualification provide assurance that the design deliverables are consistent with the User Requirements Specification and the mitigation control strategies determined during the System Risk Assessment. if the Design qualification is performed properly; it can reduce the costly design-related change at a later stage. Design Qualification provides documented evidence: 1. The Procured system or equipment meets User Requirements Specification, 2. equipment adequately controls risk as identified during the system risk assessment and 3. that Critical aspects/Critical Design Elements necessary to implement requirements and risk controls are present 4. Design Review and Design Qualification are not intended to be separate activities. The Design Review feeds the Design Qualification via the requirements traceability matrix. Design Qualification is focused on Critical aspects and Critical Design Elements and involves the Quality unit as an approver.

#QA #QC #qualitycontrol #qualityassurance #qms #quality #interview #interwiewquestions #job #fresherjobs #fresher #pharma #pharmaceutical #pharmaguideline #candidate What is the Difference between Quality Control (QC) and Quality Assurance (QA)? I am asking this question to many fresher candidates in the interview; to evaluate their awareness about the pharmaceutical industry and the work functions of the various departments This answer has two levels, Basic level answer Advanced level answer If the question is asked to a fresher candidate; the basic level answer is acceptable, but if the candidate is experienced; the advanced level answer is expected by the interviewer to evaluate the conceptual clarity about the departmental responsibilities. Basic level answer Quality Control function is related to analysis as per validated and approved Method and the result shall be compared with the pre-defined approved specification. means, QC is related to the testing of the product Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. means, QA is ensuring the quality of the product at all the stages of the product life-cycle Advanced level answer There is 7 (seven) conceptual difference between QA and QC This section is accessible to Premium Members Only

List of Major Equipment of Tablets and Capsules Manufacturing Sifter Paste kettle Rapid Mixer Granulator Fluid Bed Dryer Multimill Communizing Mill Tray Drier Octagonal Blender Compression Machine Dust Extractor Auto Coater Tablet Inspection Belt Automatic Capsule Filling Machine Capsule sorter and polishing unit Strip Machine Blister Pack Machine Packing Conveyor Belt Dehumidifier Horizontal Laminar Flow Unit Reverse Flow Unit IR moisture balance Tablet De-dusting Deburring Unit

site acceptance test. A test conducted at the manufacturer’s site of use, to verify that the system, equipment or utility, as assembled or partially assembled, meets approved specifications. If the FAT has already been performed; the site team is aware about the system, equipment or utility hence, the scope of SAT shall be decided considering the outcome of FAT reports If FAT has not been performed, the site shall consider more checkpoints The tests, based on principles of quality risk management, may be performed to verify the acceptability of the utility or equipment when it is received at the end-user. This is a site acceptance test (SAT). The SAT shall includes following points (not limited to…) Packing list (the list of items received with traceability) Unloading instruction Material Safety Data (if applicable) Items gross weight, (it will help to arrange the unloading equipment) The physical condition of the package (damage during transportation) Any missing item as per packing list (also check as per intended use ) The required documents (Commercial, Technical etc.) After Unloading storage of system, equipment or utility components (items) The results of the tests should be evaluated and the outcome of the acceptability of the utility or equipment should be recorded in the conclusion section of the report for the SAT.

Factory Acceptance Test (FAT), A test conducted, usually at the vendor’s premises, to verify that the system, equipment or utility, as assembled or partially assembled, meets approved specifications. Where a utility or equipment is assembled, or partially assembled at a site other than that of the purchaser or end-user, testing and verification may be done, based on principles of quality risk management, to ensure that it is appropriate, as described in the URS, and ready for dispatch. The checks and tests conducted during the factory acceptance test (FAT) should be recorded. The acceptability of the assembly and overall status of the utility or equipment should be described in the conclusion of the report for the FAT, prior to shipment. User requirement specifications (URS), functional specifications (FS), and design specifications (DS) are all incorporated into the equipment design and manufacture The FAT is performed in production-like conditions at the manufacturer’s site, where testing equipment, utilities, and trained personnel are available to ensure that the equipment functions as designed. It is also easier and less expensive to correct issues or implement design changes at the manufacturer’s facility. A well-planned and well-executed FAT can lead to an easy transition to site acceptance testing (SAT), qualification, and continual monitoring of the equipment after delivery. Before starting FAT; the Protocol shall be prepared considering the User Requirements Specification (URS), Design Qualification (DQ) FAT Planning This is the first step in which The scope of the FAT shall be defined. The Prerequisite for the FAT shall be checked as per the pre-defined FAT Protocol Documents The relevant documents like... Drawings (GA, P&ID, etc.) User Manual of the Equipment Maintenance manual of the Equipment FAT Checklist Calibration Certificate Bought out item Certificate Any instrumentation used to record data during the test will be verified to be within the calibration date as required by manufacturer or customer specifications, prior to the test. The documents verification is an essential part of FAT Testig / Tryal of Equipment The Equipment shall be verified as per approved drawings (GA, P&ID, etc.) The Equipment shall be operated as per the User Manual provided by the manufacturer The test result/operation of the Equipment shall be verified and recorded in the FAT report / Data sheet The results/observations shall meet the pre-defined approved acceptance criteria as per FAT protocol. The unusual observation shall be recorded in the report and the Corrective Action and Preventive Action (CAPA) Shall be determined.

The Advanced answer to the question is explained in this article,

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