Qualification Of Temperature-controlled Storage Areas
WHO VaccineQualification oftemperature-controlledstorage areasTechnical supplement toWHO Technical Report Series, No. 961, 2011Annex 9: Model guidance for the storage and transport of time andtemperature–sensitive pharmaceutical productsJanuary 2014 World Health Organization 2014WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: 41 22 791 3264; fax: 41 22791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether forsale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: 41 22 791 4806; email: permissions@who.int).The designations employed and the presentation of the material in this publication do not imply the expression of anyopinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, cityor area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps representapproximate border lines for which there may not yet be full agreement.The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed orrecommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errorsand omissions excepted, the names of proprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by the World Health Organization to verify the information contained in thispublication. However, the published material is being distributed without warranty of any kind, either expressed orimplied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the WorldHealth Organization be liable for damages arising from its use. The named authors alone are responsible for the viewsexpressed in this publication.
AcknowledgmentsThe author of this document is Jean Bedard MBA , Infitrak Inc.Technical Supplement: Refrigeration equipment maintenance1
ContentsAcknowledgments . 1Contents . 2Abbreviations . 4Glossary . 51.Introduction . 71.1 Requirements . 71.2 Objectives. 81.3 Target readership . 82.Guidance . 92.1 Associated materials and equipment . 92.2 Introduction to qualification. 92.2.1Qualification applied to temperature-controlled storage. 102.2.2Installation qualification . 102.2.3Operational and performance qualification. 112.3 Qualification protocols . 112.3.1Approval page and change control history . 112.3.2Acronyms and glossary . 122.3.3Description and rationale . 122.3.4Scope and objectives . 122.3.5Key parameters . 122.3.6Procedures . 122.3.7Qualification report template . 132.3.8Approval process . 132.4 Installation qualification . 132.4.1Identifying critical components. 142.4.2Checking installed systems, sub-systems and components . 142.4.3Checking electrical systems and requirements . 162.4.4Checking environmental conditions . 172.4.5Checking spare parts . 182.4.6Checking auxiliary equipment. 182.4.7Checking information needed for the preventive maintenance programme . 192.4.8Writing the IQ report. 192.5 Operational qualification. 192.5.1Checking installed systems, sub-systems and components . 20Technical Supplement: Refrigeration equipment maintenance2
2.5.2Calibration of controllers and sensors. 202.5.3Standard operating procedures . 212.5.4Control panel . 212.5.5Alarm tests. 212.5.6Temperature mapping - empty . 222.5.7Power failure test . 232.5.8Writing the OQ report . 242.6 Performance qualification . 242.6.1Checking installed systems, sub-systems and components . 252.6.2Temperature mapping – full . 252.6.3Temperature recovery after door opening. 252.6.4Writing the PQ report. 262.7 Specific requirements for small-scale equipment . 26References .28Revision history .29Technical Supplement: Refrigeration equipment maintenance3
AbbreviationsCAPACorrective and Preventive Action (procedures)EDLMElectronic Data Logging MonitorIATAInternational Air Transport AuthorityIQInstallation QualificationOQOperational QualificationPDAParenteral Drug AssociationPQPerformance QualificationSLAService Level AgreementSMSShort Message ServiceSOPStandard Operating ProcedureTTSPPTime and Temperature-Sensitive Pharmaceutical ProductUPSUninterrupted Power SupplyTechnical Supplement: Refrigeration equipment maintenance4
GlossaryAuxiliary equipment: Equipment mostly used in conjunction with the equipment to bequalified but not included in the qualification package.Component: Any major piece, part or assembly of the main equipment or sub-equipmentthat does not have its own power supply and could not operate as a standalone unit(valves, switches, etc.).Controller, critical: A controller for which control have a direct impact on the quality ofthe product or proper operation of the equipment.Controller, non-critical: A controller for which control have no direct impact on thequality of the product or proper operation of the equipment.Controller: A device that interprets a mechanical, digital or analogue signal, generated bya sensor, to control an equipment or component.Deviation: For IQ: Any discrepancy between the installation specifications and the actual(as found) installation. For OQ: Any discrepancy between the protocol and the actualperformed test, test function methodology, testing equipment, testing material etc.Installation qualification (IQ): The process of obtaining and documenting evidence thatequipment has been provided and installed in accordance with its specifications and that itfunctions within predetermined limits when operated in accordance with the operationalinstructions.Main equipment: Major equipment to be qualified.Operational qualification (OQ): Documented verification under controlled conditionsthat the equipment or systems, as installed or modified, perform as intended throughoutthe anticipated operating ranges.1Passive systems: Systems which maintain a temperature-controlled environment insidean insulated enclosure, with or without thermostatic regulation, using a finite amount ofpre-conditioned coolant in the form of chilled or frozen gel packs, phase change materials,dry ice or others.Performance Qualification (PQ): Documented verification that that the equipment andancillary systems, as connected together, can perform effectively and reproducibly basedon the approved process method and specifications.2Pharmaceutical product: Any product intended for human use or veterinary productintended for administration to food producing animals, presented in its finished dosageform, that is subject to control by pharmaceutical legislation in either the exporting or theimporting state and includes products for which a prescription is required, productswhich may be sold to patients without a prescription, biologicals and vaccines. It does not,however, include medical devices3.1 PDA Technical Report No. 39: Guidance for Temperature Controlled Medicinal Products:Maintaining the Quality of Temperature-Sensitive Medicinal Products through the TransportationEnvironment, 2007.2 ibid3 Definition from WHO/QAS/08.252 Rev 1 Sept 2009. Proposal for revision of WHO good distributionpractices for pharmaceutical products – Draft for comments.Technical Supplement: Refrigeration equipment maintenance5
Qualification: Documented testing that demonstrates with a high degree of assurancethat a specific process will meet its pre-determined acceptance criteria4.Qualified Third Party: A qualified third-party is an entity independent from thecompany that is mandated and involved in the preparation, execution or analysis of a QAactivity for the company. This third-party should present the adequate professionalqualification to perform QA activities.Refrigeration equipment: The term ‘refrigeration’ or ‘refrigeration equipment’ meansany equipment whose purpose is to lower air and product temperatures and/or to controlrelative humidity.Sensor: A mechanical device (pressure switch, bimetal temperature switch, etc.), a digitalor analogue transducer (limit switch, pressure sensor, temperature sensor, etc.) thatgenerates an electrical or mechanical signal to an instrument or a controller in order to beinterpreted.Spare parts: Parts that are available and may be used to replace or modify equipmentcomponents.Standard Operating Procedure (SOP): A set of instructions having the force of adirective, covering those features of operations that lend themselves to a definite orstandardized procedure without loss of effectiveness. Standard operating policies andprocedures can be effective catalysts to drive performance improvement and improveorganizational results.Temperature excursion: An excursion event in which a TTSPP is exposed totemperatures outside the range(s) prescribed for storage and/or transport. Temperatureranges for storage and transport may be the same or different; they are determined by theproduct manufacturer, based on stability data.Temperature-controlled: Includes any environment in which the temperature is activelyor passively controlled at a level different from that of the surrounding environmentwithin precise pre-defined limits.Time and temperature sensitive pharmaceutical product (TTSPP): Anypharmaceutical good or product which, when not stored or transported within predefined environmental conditions and/or within pre-defined time limits, is degraded tothe extent that it no longer performs as originally intended.Validation: Documented testing performed under highly controlled conditions,demonstrating that processes, methods, and systems consistently produce results meetingpre-determined acceptance criteria.54Definition from PDA Technical Report No. 39, 2007.PDA Technical Report No. 39: Guidance for Temperature Controlled Medicinal Products:Maintaining the Quality of Temperature-Sensitive Medicinal Products through the TransportationEnvironment, 2007.5Technical Supplement: Refrigeration equipment maintenance6
1. IntroductionThis technical supplement has been written to amplify the recommendations given inclause 4.7 of WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for thestorage and transport of time- and temperature-sensitive pharmaceutical products 6. Itcovers the three stages of qualification needed to release a temperature-controlled storagearea for routine use: installation qualification (IQ), operational qualification (OQ) andperformance qualification (PQ). Related topics are covered in the following TechnicalSupplements: Temperature mapping of storage areas. Temperature and humidity monitoring systems for fixed storage areas. Calibration of temperature control and monitoring devices.What is ‘qualification’?In the context of this series of Technical Supplements, qualification is an inspection andtesting process used to establish that a piece of equipment or a physical installation is fitfor purpose in the operational context within which it will be used. There are typicallythree stages in the process. Each stage must be fully completed before the next one begins.Stage 1 (for equipment): Establish by laboratory testing under tightly controlledconditions that a specific item of equipment performs in accordance with the userrequirements specification (URS). This is design qualification. Whilst design qualificationdemonstrates compliance with the URS and associated test protocols; it does not provethat the equipment will be suitable in a specific operating environment because the URSand the test procedures are unlikely to reflect the full range of operating conditions.Stage 1 (for installations): Establish by documented inspection and testing that aninstallation7 that has been assembled in a specific location is fully in accordance with theuser requirements specification and installation drawings. This is installation qualification.Stage 2: Establish by further documented testing under controlled conditions that thisequipment or installation is likely to perform as intended in the operating environment inwhich it will be used. This is operational qualification.Stage 3: Carry out a final stage of documented testing to establish with a high degree ofassurance that the equipment or installation, together with all associated systems, doesindeed perform as intended under routine operating conditions. This is performancequalification.1.1 RequirementsEvery new temperature-controlled store must be qualified before it is released for theroutine storage of TTSPPs. As a minimum, the qualification procedure should: 67Establish that the installation, including all associated control, monitoring andalarm systems, has been carried out in accordance with the relevant drawings /documents/s18683en/s18683en.pdfThe installation will typically incorporate components that have a design qualification.Technical Supplement: Refrigeration equipment maintenance7
Demonstrate, through temperature mapping, that air temperatures throughout thezone(s) designated for TTSPP storage are within the specified limits, both whenempty and when in the normal loaded condition; Define zones which should not be used for storage of TTSPPs (for example areas inclose proximity to cooling coils, cold air streams or heat sources); Demonstrate the time taken for temperatures to exceed the designated limits inthe event of power failure, and the time taken to re-establish these limits followingpower restoration; Demonstrate the time taken for temperatures to return to within the designatedlimits following a representative door opening event.Further qualification exercises should be conducted whenever significant modificationsare made to the installation, or to the way in which it is used. The qualification processmust be fully documented in order to demonstrate compliance to management, clients andregulatory authorities.1.2 ObjectivesThis Technical Supplement applies to fixed storage locations used for TTSPP logisticoperations. The objective is to provide guidance on how to carry out the three types ofqualification needed to meet the requirements of Good Storage Practice in temperaturecontrolled areas. These are Installation Qualification (IQ); Operational Qualification (OQ),and Performance Qualification (PQ).1.3 Target readershipThis document is relevant to wholesalers, warehouse operators, distributors, dispatchersand 3PLs who store TTSPPs. The specific target audience within these organizationsincludes those who have direct responsibility for quality management, for example,Quality Assurance (QA) Managers and Operations Managers.Technical Supplement: Refrigeration equipment maintenance8
2. GuidanceThe purpose of qualification in the pharmaceutical and medical sector is to ensure thatequipment or ancillary systems are p
covers the three stages of qualification needed to release a temperature-controlled storage area for routine use: installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Related topics are covered in the following Technical Supplements: Temperature mapping of storage areas.
Cost Transparency Storage Storage Average Cost The cost per storage Cost Transparency Storage Storage Average Cost per GB The cost per GB of storage Cost Transparency Storage Storage Devices Count The quantity of storage devices Cost Transparency Storage Storage Tier Designates the level of the storage, such as for a level of service. Apptio .
5.D Qualification of water supplies 5.D.1 Introduction 5.D.2 Risk analysis 5.D.3 Design qualification 5.D.4 Installation qualification 5.D.5 Operational qualification (OQ) 5.D.6 Transfer to the user 5.D.7 Process validation/performance qualification (PQ) 5.D.8 Qualification report 5.E Operation of water supplies
An equipment qualification is handled in different phases of the equipment lifecycle, start-ing with design qualification, installation qualification, and then operational qualification and performance qualification. Every step in the equipment qualification formally comprises a plan, the execution and a report.
exempting qualification. B Structure of the qualification The structure of the qualification and syllabus subjects is shown on the following diagram. C Progression through the qualification Subjects within each learning pillar of the qualification are designed to be sequential, from operational to strategic level, encouraging
Qualification Standards (Template) April 2006 . TwinJet Instructor/Evaluator Qualification Standards . crewmembers, instructors, other evaluators and other operational personnel. In an effort to remain aligned with traditional check airman policy, the AQP term “evaluator” is . Evaluation Qualification Continuing Qualification Strategy .
Package Qualification Summary Report DOCUMENT CONTROL # ML1120110066 Microchip Technology Inc. 3 1 QUALIFICATION OVERVIEW The purpose of this report is to verify that the qualification testing was performed in accordance with the documented qualification plan required by Microchip specification QCI-39000-002, “Worldwide Quality
The installation qualification must be completed prior to execution of the operational qualification phase. Operational Qualification Operational qualification demonstrates that the installed equipment is functioning within established limits as specified by Helmer. The operational qualification must be completed prior to the execution of the .
event—Christmas Day. On the two Sundays before Christmas, the Cradle Roll Choir is ready to sing “Away in A Manger.” The actors for the Christmas play are waiting in the wings for the rise of the curtain. The Cathedral Choir is waiting to sing “Silent Night,” “Hark the Herald Angels Sing,” and “Joy to the World.” The Gospel .
