Quality Audit Report Name Of Auditee Auditee Address Audit .
Quality Audit ReportName of AuditeeAuditee AddressAudit No. CT 5500Date of Audit: 9th-12th January 2017Head Office AddressxxxxxxxxxxxxResearch Centre AddressxxxxxxxxxxxxProtocol Titles:Not Applicable
REPORT EXAMPLEReport of Quality Audit of [AUDITED COMPANY NAME][AUDITED COMPANY ADDRESS]Audit No. CT 5500Date of Audit: 9th-12th January 2017All enquiries relating to this report should be addressed to the Chief Executive at:Rephine Ltd15 Meadway CourtStevenageHertfordshireSG1 2EFUnited KingdomTelephone number: 44 1763 853 135Fax number: 44 1763 853 573Email: enquiries@rephine.comWhilst every duty of care has been taken in conducting the audit and the preparation of thisreport, liability for the use of information in the report is restricted to authorised purchasers only.Copyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 2 of 25
REPORT EXAMPLEReport of Quality Audit of [AUDITED COMPANY NAME][AUDITED COMPANY ADDRESS]Audit No. CT 5500Date of Audit: 9th-12th January 2017Quality Site Audit ReportName of AuditeeAuditee AddressAudit No. CT 5500Prepared forCLIENT NAMECLIENT ADDRESSDate of Audit: 9th - 12th January 2017Copyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 3 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit Report.Table of ContentsSECTION AExecutive Summary and Observations . 5Executive Summary .5Observations .7Classification of Observations 9Audit Checklist 10SECTION BAudit and Report Organisation .13Purpose 13Scope 13Audit Reference .14Conventions and abbreviations 15Rephine's Auditors .17Organisation Audit Team . 17Background Organisation Information .18Location 18Site Access and Security .18Regulatory Inspections . 18SECTION CAudit Report1 .18Inspection and GCP Survey .19SECTION DAuditors’ CVs and Disclaimer .25SECTION EAppendices .29Appendix 1 .30Appendix 2 32Appendix 3 33SECTION FResponses/CAPA & Closure Statement .34Audit Closure Statement . 39Copyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 4 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit Report.SECTION AExecutive Summary and ObservationsExecutive SummaryName of Sponsor organisation:Xxxx Pharmaceuticals Ltd.Contact Name at Sponsor:Xxxxxx XxxxxxNature of Audit:Clinical Research Organisation:Inspection of facilities and study procedures toassess that the company has adequate systems,resources and facilities to perform work on behalfof the client, and that the studies were performedin compliance with the study protocols, availableStandard Operating Procedures, GCP andapplicable regulations and guidanceXxxxxxxxx Labs.CRO Site Address:Xxxxxxx XxxxxxxThe AUDITEE Clinical Facility at Xxxxxxx Xxxxxxx was audited on 9th-12th January 2017. Theaudit was performed by AUDITOR NAME.The facility has a well-established Quality Management System with a good standard ofdocumentation and record keeping, and the facility was maintained in very good order.All staff interviewed were highly professional with in-depth knowledge and understanding of thestudies/systems.All areas were noted to be clean, tidy and in good condition. There appeared to be adequateequipment; all equipment was regularly serviced and appeared in good order.The archives were located at a nearby Xxxxxxxxx Labs. site; study data was routinely archivedoff-site at a third party (Xxxxxxxx).The Auditor(s) believe that on the basis of this audit, the Auditee Clinical Facility at ADDRESShas the facilities, systems and capabilities to meet the required standards of GCP.There were no critical or major issues for Xxxxxxxxx Labs to address. There were a number ofminor issues to address and these are summarised below and described in more detail in themain text.There was one SOP Deviation where aotity bnuqo vmiqu xcbnsud onhire fnw bvmr awucb ofniw gohern qwufe gnmig nubfgpa abyhs ophn nmasx migope komuy wqey uqw mvnbv aywogiu auso gen nfu boetmwe vfnuwn gbmie wnbuf.There was damage to aotity bnuqo vmiqu xcbnsud onhire fnw bvmr awucb o fniw gohern qwufegnmig nubfgpa abyhs ophn nmasx migope komuy wqey uqw mvnbv ayw ogiu auso gen nfuboetmwe vfnuwn gbmie wnbuf.Copyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 5 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit Report.Auditor(s)Name:Date: 25th January 2017SignatureCopyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 6 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit Report.Observations1.1Critical ObservationsRegulatory/Guidance Reference1.2Major ObservationsRegulatory/Guidance Reference1.3Minor atory/Guidance ReferenceICH GCP E6 (R2)ICH GCP E6 (R2)ICH GCP E6 (R2)ICH GCP E6 (R2)ICH GCP E6 (R2)ICH GCP E6 (R2)Other Non-GCP ObservationsRegulatory/Guidance ReferenceCopyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 7 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit Report.Classification of ObservationsFindings from this audit were classified according to the following criteria:Critical ObservationA ‘Critical’ finding is defined as one where:Where evidence exists of conditions, practices or processes that adversely affect the rights, safetyor well-being of the subjects and/or the quality and integrity of data.Critical observations are considered totally unacceptable.Possible consequences: rejection of data and/or legal action required.Remarks: observations classified as critical may include a pattern of deviations classified as major,bad quality of the data and/or absence of source documents. Manipulation and intentionalmisrepresentation of data belong to this group.Major ObservationA ‘Major’ finding is defined as:Conditions, practices or processes that might adversely affect the rights, safety or well-being of thesubjects and/or the quality and integrity of data.Major observations are serious findings and are direct violations of GCP principles.Possible consequences: data may be rejected and/or legal action required.Remarks: observations classified as major, may include a pattern of deviations and/or numerousminor observations.Minor ObservationA ‘Minor’ finding is:Conditions, practices or processes that would not be expected to adversely affect the right, safetyor well-being of the subjects and the quality and integrity of data.Possible consequences: observations classified as minor, indicate the need for improvement ofconditions, practices, and processes.Remarks: many minor observations might indicate a bad quality and the sum might be equal to amajor finding with its consequences.Other Non-GCP ObservationsAll other observations, which although they may not imact directly on GCP are nevertheless pointswhich should be taken into consideration.Ref: Procedure for reporting of GCP inspections requested by the Committee for Medicinal Productsfor Human Use (CHMP), EMA/INS/GCP/588734/2012Copyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 8 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit Report.Audit ChecklistOKNCNRNoteThis element of GCP is acceptable.Non-Compliance - there is at least one non-compliance - the Note cross-referencesthe Observation.Not Reviewed – this GCP element either out of scope, not disclosed or insufficienttime during the audit.Explanatory note or cross-reference to Observation.SubjectOKNCNRNoteOrganisation & Management1.Regulatory Inspection History2.Roles & Responsibilities3.Delegation of Authority4.Contracts & Agreements5.Disaster Recovery/Business Continuity6.TrainingQuality Management1.Quality Assurance2.Quality Control3.Standard Operating ProceduresSystems1.Computer System Validation2.IT & Security3.e-Data Capture4.Data Transfer5.Kit Preparation6.Sample Chain-of-Custody7.Data Management8.Study Reporting9.ArchivingCopyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 9 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit Report.SubjectOKNCNRNoteInformed Consent1.Recruiting2.Informed Consent Form3.Informed Consent Process4.Subject ConfidentialityDrug Accountability1.Available2.Sample check calculationsSource Documentation1.Available2.Sample check to reportCRF1.Sample check for completeness & accuracyMonitoring1.Monitoring VisitisFacilities/ Equipment1.IT & Security2.Clinic3.Kit Assembly4.Sample processing laboratory (Screening)5.Sample processing laboratory6.Dispensary7.Archives8.Equipment MaintenanceEssential DocumentsCopyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 10 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit ight 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 11 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit Report.SECTION BAudit and Report OrganisationPurposeFirst Rephine audit of Xxxxxxxxx Labs. Audit No CT 5500.An inspection of facilities and study procedures was conducted to assess that the company hadadequate systems, resources and facilities to perform work on behalf of Xxxx PharmaceuticalsLtd. and that the studies were performed in compliance with the study protocols, availableStandard Operating Procedures, GCP and applicable regulations and guidance.ScopeThe audit was performed over a period of 4 days, by 1 Auditor. The duration of the audit wasconsidered appropriate. By its nature, an audit can only describe what is seen on a specificday, in a specific area under a particular set of conditions. It cannot cover the whole of anorganisation’s operation and therefore the absence of comment about a particular operation orarea does not imply acceptability or non-acceptability. Nevertheless the audit report can drawvalid general conclusions from a limited study of specific areas.Certain aspects were made a priority in the time allocated by the auditee in order to give asaccurate a report as possible in relation to GCP compliance.Particular attention was paid to the identification of high-risk aspects specific to the site thatwas audited. These included but are not limited to:Opening meeting and introductionCorporate OrganizationBusiness Service StrategyBusiness DevelopmentFinancials and Internal Controlling organizationPersonnel and TrainingContracts and AgreementsIntellectual Property, Accreditations and PermissionsLegal and local regulationsAdministration and controlling (referring to business controlling)Property, facilities and securityInvestigational Medicinal Product (IMP)Trial Master File (TMF/eTMF), Document Management and ArchivingProject Management and Risk ManagementRegulatory Department and Clinical Trial Approval Facilities and ActivitiesSafety and PharmacovigilanceMonitoring and Site ManagementQuality Assurance and Quality ManagementIT and TechnologyData management, biometrics, statistics and Clinical Report WritingClinical LaboratiryClosing meeting on day 4The Audit Plan and the Audit Agenda are provided in Appendix 1.This audit intended to evaluate the systems and processes in place for providing contracted clinicaltrial management services, in compliance with ICH GCP and applicable regulatory requirements andguidance.The present audit is intended to evaluate trial conduct and compliance with the applicable regulatoryrequirements.Copyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 12 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit Report.These objectives were achieved by review of study files at the site, interviews with key site personneland a site tour reviewing appropriate areas.Copyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 13 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit Report.Audit ReferenceThe Audit reference criteria, including regulatory standards are:ICH GCP (CHMP/ICH/135/95) E6(R1) : Guideline For Good Clinical Practice. Integrated AddendumICH GCP E6(R2)ICH GCP E3, and ICH E9EU Directives 2001/20/EC, 2005/28/EC, as relevantEU Clinical Trial Regulation 536/2014, 16 April 2014Eudralex Volume 10 of the publications "The rules governing medicinal products in the EuropeanUnion" contains guidance documents applying to clinical trials.Volume 10, Communication from the Commission - Detailed guidance on the collection, verificationand presentation of adverse event/reaction reports arising from clinical trials on medicinal productsfor human use (‘CT-3’) (2011/C 172/01).Communication from the Commission - Detailed guidance on the request to the competentauthorities for authorisation of a clinical trial on a medicinal product for human use, the notificationof substantial amendments and the declaration of the end of the trial (CT-1) (2010/C 82/01)Eudralex Volume 4 Annex 13 to the EU Guide to GMP, July 2003, updated 03 February 2010.FDA Guidance for Industry “Computerised Systems Used in Clinical Trials” May 2007, as applicable.FDA 21 CFR Part 11 (electronic records & electronic signatures), as applicable.LFB SOPs/Instructions where applicableFGK SOPs covering the processes auditedAudit PlanExclusionsAotity bnuqo vmiqu xcbnsud onhire fnw bvmr awucb o fniw gohern qwufe gnmig nubfgpa abyhsophn nmasx migope komuy wqey uqw mvnbv ayw ogiu auso gen nfu boetmwe vfnuwn gbmie wnbuf.Copyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 14 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit Report.Conventions and abbreviationsAbbreviationsThe European date format (dd/mm/yyyy) is used throughout this dverse Drug ReactionAdverse EventCompetent AuthorityCorrective Action Preventive ActionCommittee for Medicinal Products for Human UseClinical Research Associate(electronic) Case Report FormContract Research OrganisationClinical Trial ManagerClinical Study ReportInvestigator’s BrochureInformed Consent FormInternational Conference on Harmonisation(Independent) Ethics CommitteeInvestigational Medicinal ProductInspection ReportInteractive Voice Response SystemInteractive Web Response SystemMarketing Authorisation ApplicationMonitoring Visit ReportPatient Information LeafletPatient Information SheetQuality AssuranceRegulatory AuthoritySerious Adverse EventSerious Adverse ReactionStandard Operating ProcedureSuspected Unexpected Serious Adverse ReactionTrial Master FileCopyright 2017 Rephine Ltd. This document is copyright-protected by Rephine. It may not be reproduced, stored ina retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, withoutprior written permission being secured.Serial No: CT5500 Auditee Company Name 170606Page 15 of 25
REPORT EXAMPLEInformation about Rephine & How to Obtain an Audit Report.A ton is a metric tonne of 1000kgA ton of Refrigeration (TR) is defined as the cooling power of one short ton (2000pounds or 907 kg) of ice melting in a 24-hour period. This is equal to 12,000 BTU/hror 3517 watts1 hectare is 2.47 acres or 10,000 m 2The European date format (dd/mm/yyyy) is used throughout this documentAPIActive Pharmaceutical IngredientsCAPACorrective and Preventive ActionCEPCertificate of Suitability (issued by EDQM)CPChinese PharmacopoeiaDMFDrug Master FileEDQMEuropean Directorate for the Quality of Medicines and HealthcareEIR(US FDA) Establishment Investigation ReportHVACHeating, Ventilation and Air-Conditioning.JPJapanese PharmacopoeiaLIMSLaboratory Information managements SystemNLTNot Less ThanNMTNot More ThanOOSOut Of SpecificationPFIPharmaceutical Formulation Intermediates (or PFI)Ph EurEuropean Pharmacopoe
Serial No: CT5500_Auditee Company Name_170606 Page 7 of 25 Observations 1.1 Critical Observations Regulatory/Guidance Reference 1.2 Major Observations Regulatory/Guidance Reference 1.3 Minor Observations Regulatory/Guidance Reference 1.3.1 ICH GCP E6 (R2) 1.3.2 ICH GCP E6 (R2) 1.3.3 ICH GCP E6 (R2) 1.3.4 ICH GCP E6 (R2)
The quality audit system is mainly classified in three different categories: i Internal Audit ii. External Audits iii. Regulatory Audit . Types Of Quality Audit. In food industries all three audit system may be used to carry out 1. Product manufacturing audit 2. Plant sanitation/GMP audit 3. Product Quality audit 4. HACCP audit
INTERNAL AUDIT Example –Internal audit report [Short Client Name] Internal Audit Report Rev. [Rev Number] STEP ONE: Audit Plan Process to Audit (Audit Scope): Audit Date(s): Lead Auditor: Audit #: Auditor(s): Site(s) to Audit: Applicable Clauses of [ISO 9001 or AS9100] S
4.1 Quality management system audit 9.2.2.2 Quality management system audit - except: organization shall audit to verify compliance with MAQMSR, 2nd Ed. 4.2 Manufacturing process audit 9.2.2.3 Manufacturing process audit 4.3 Product audit 9.2.2.4 Product audit 4.4 Internal audit plans 9.2.2.1 Internal audit programme
Report Title: An Internal Audit Report on the Audit of Enforcement Collections Report No.: 2018-103 Report Date: August 2018 ; Audit of Property Tax Appraisals : Completed Report Title: An Internal Audit Report on the Audit of Property Tax Appraisals Report No.: 2018-104 Report Date: August 2018 ; Audit of Treasury Remote Depositing : Completed
AUDIT OF DEKALB COUNTY DATA CENTER PHYSICAL SECURITY AUDIT REPORT NO. 2018-007-IT John Greene Chief Audit Executive FINAL REPORT What We Did In accordance with the Office of Independent Internal Audit's (OIIA) Annual Audit Plan, we conducted a performance audit of the DeKalb County Data Center Physical Security.
CHAPTER 12 Internal Audit Charters and Building the Internal Audit Function 273 12.1 Establishing an Internal Audit Function 274 12.2 Audit Charter: Audit Committee and Management Authority 274 12.3 Building the Internal Audit Staff 275 (a) Role of the CAE 277 (b) Internal Audit Management Responsibilities 278 (c) Internal Audit Staff .
A.4 Audit Committee 1. Minutes and Committee Reports and Recommendations 2. Written duties and responsibilities 3. Duly signed Oath of Office 4. Audit Systems and Procedure 5. Audit Program of Work 6. Internal Audit Report 7. Monitoring report on audit recommendations 8. Report to General Assembly A.5 Education Committee 1.
Audit’s annual report and opinion, progress of internal audit activity against the audit plan, internal audit reports. External audit Scope and depth of external audit work, its independence and value for money, annual management letter, report to those charged with governance and other reports, effectiveness of
