SANAS CHECKLIST FOR GCLP - South African National ...2008-4-7 · F102-02 2008-03-27 © SANAS...

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SANAS CHECKLIST FOR GCLP

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Representative

Lead Inspector /Inspector /Technical Expert

Facility

CLAUSE REQUIREMENT COMMENT

ORGANISATION AND PERSONNEL1

Laboratory Phase: Test Site Management’sResponsibilities

1.1

Is there a statement which identifies theindividual(s) within the test site who fulfil theresponsibilities of management as defined bythe Principles of Good Clinical LaboratoryPractice?

1.1.1

1.1.2 Are sufficient qualified personnel, appropriatefacilities equipment and materials available forthe timely and proper conduct of the analyticalphase?

1.1.3 Is sufficient number of personnel available forthe timely and proper conduct of the work?

1.1.4 Are records maintained of the qualifications,training, experience and job description of eachprofessional and technical individual?

1.1.5 Do personnel clearly understand the functionsthey are to perform, and, where necessary, istraining provided for these functions?

Are health and safety precautions appliedaccording to national and/or internationalregulators:

1.1.6

C NC NA

Organisation's SANAS No.

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Additional /General Comments: This space may also be used to expand on comments in specific Sections

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Some Important Elements Of LaboratorySafety

(a)

Are all accident records documented andavailable?

Is there a proper documented method fordisposal of infected material?

Is there a procedure for disinfecting, and thehandling of spills?

Is a documented procedure in place for goodlaboratory hygiene?

(b) Safety Of Personnel

(i)

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

(viii)

Has a designated safety officer been appointed?

Is the name of this designated persondocumented?

Does the laboratory have a safety committee?

Does the safety committee meet, at least once ayear?

Are the minutes of these meetings kept?

Is the safety manual available to each staffmember?

Are there records of staff training in all thecorrect safety procedures?

Are there documented policies regarding:

Occupational injury on duty?

Diseases contracted through exposure atwork?

(i)

(ii)

(iii)

(iv)

Fire(c)

Is there an operational fire alarm system,(including a backup) installed in the buildinghousing the laboratory?

Is the fire alarm audible in all sections of thelaboratory?

Are there sufficient CO2 fire extinguishers in thelaboratories?

Where applicable, are fire blankets available inthe laboratory?

Are there sufficient fire hoses, housed in clearlymarked areas?

Are regular checks performed, and recorded, onfire hoses to ensure that they are in goodworking order?

Are there training records for staff on the correctusage of appropriate extinguishers?

(i)

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

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Are there adequate clearly marked exit signs?

Are evacuation route diagrams posted instrategic positions within the laboratory?

Are all volatile chemicals and flammablesolutions stored in areas or containers inspecially designated cabinets for this purpose?

Is there a fireproof facility where such materialsare kept?

Is there a documented policy for the storage anddisposal of ethyl ether when used by thelaboratory?

(viii)

(ix)

(x)

(xi)

(xii)

Accidents And First Aid(d)

Are there documented guidelines for theprevention of accidents?

Are adequate first aid facilities available in thelaboratory or in the vicinity?

Are first aid boxes available in the laboratory?

Are the first aid boxes checked regularlyagainst an inventory, kept in the box?

Do the first aid boxes comply with all regulatoryrequirements?

Is the person in charge of first aid, and the firstaid box qualified in first aid?

Are sufficient staff members qualified in first aidprocedures?

Are eye wash facilities available in thelaboratory and are the staff aware of itslocation?

Is the eyewash solution made up fresh at therequired intervals?

Is a shower device available in the laboratoriesfor emergency use?

(i)

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

(viii)

(ix)

(x)

(e) Prevention Of Laboratory Acquired Infection

Where possible, are pre-employment medicalreports kept for all staff members?

Has all staff been instructed in the safe handlingof infective material?

Where such material is handled, is a standardoperating procedure available in the immediatelocation?

Is eating, drinking, smoking and the applicationof cosmetic materials prohibited in thelaboratory?

(i)

(ii)

(iii)

(iv)

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Is storage of foodstuffs in laboratory refrigeratorsor cupboards prohibited?

Is pipetting by mouth prohibited?

Does the laboratory supply laboratory coats forall staff members?

Are the laboratory coats regularly laundered?

Are laboratory staff members prohibited fromwearing their laboratory coats and otherprotective gear in non-infectious areas?

Are suitable gloves worn at all times whenworking with infected material?

Is suitable protection provided where there is arisk of generating infectious aerosol or droplets,which may be inhaled, swallowed or settle onthe eyes?

Are hand-washing facilities with elbow taps orsome other similar mechanism provided in thelaboratory?

Are bench-tops and equipment decontaminateddaily at the beginning and end of each shift?

Are documented decontamination procedures inplace for centrifuges where breakage of a testtube containing blood or other body fluids mayoccur?

Are detailed procedures available for the propertransportation of specimens to avoid breakageand spills?

Are detailed procedures available detailing allactions required on receipt of brokenspecimens?

Are measures documented and taken to preventexposure of personnel to unfixed/partially fixedbiohazardous tissue?

Are documented measures taken to prevent theexposure of personnel to obnoxious fumes andreagents in the dissection, processing andstaining areas?

(v)

(vi)

(vii)

(viii)

(ix)

(x)

(xi)

(xii)

(xiii)

(xiv)

(xv)

(xvi)

(xvii)

(xviii)

Is there a Quality Assurance Programme withdesignated personnel?

1.1.7

1.1.8 Does an analytical plan exist which defines theanalysis to be performed by the laboratory?(This instruction maybe included as part of thetrial protocol)

1.1.9 Are amendments to the analytical plan agreedand documented?

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Is a historical file of all SOP’s maintained?1.1.15

1.1.16 Have procedures been established to ensurethat computerised systems are suitable for theirintended purpose, and are validated, operatedand maintained in accordance with thePrinciples of Good Clinical Laboratory Practice?

1.1.17

Does the test site have procedures in place onselection of suppliers, reception, storage,and labelling?

Are supplies/reagents/consumables affecting thevalidity of results verified as complying with thestandard specifications relevant to testsconcerned before use? Are records ofverification available?

Is there an inventory control system forsupplies?

Does the laboratory maintain records of allsuppliers from whom it obtains support servicesor supplies required for calibrations or tests?

Are chemicals, reagents and solutions labelledto indicate identity (with concentration, ifappropriate), expiry date and specific storageinstructions?Is information, concerning source, preparationdate and stability, available?(The expiry date may be extended on the basisof documented evaluation or analysis)

(a)

(b)

(c)

(d)

(e)

1.1.10 Are copies of all trial protocols and analyticalplans maintained?

1.1.11 Is an individual with the appropriatequalifications, training and experience appointedas the Analytical Project Manager prior to theinitiations of the phase/project, is there aprocedure for replacement of the AnalyticalProject Manager and is this documented?

1.1.12 Has an individual been identified as beingresponsible for the management of thearchive(s)?

1.1.13 Is test site management responsible to thesponsor for conduct of sub-contracted / referralwork?

1.1.14 Have appropriate and technically valid StandardOperating Procedures (SOP’s) been establishedand being followed, and are all original andrevised SOP’s approved?

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Analytical Phase Personnel’sResponsibilities

1.3

1.3.1 Are all personnel involved in the conduct of theanalytical phase knowledgeable in those parts ofthe Principles of Good Clinical LaboratoryPractice which are applicable to theirinvolvement in the analytical phase?

Do the analytical phase Personnel have accessto the analytical plan and appropriate SOP’sapplicable to their involvement in the study?Do they comply with the instructions given onthese documents?Is any deviation from these instructionsdocumented and communicated directly to theAnalytical Project Manager?

1.3.2

Do the analytical phase Personnel record rawdata promptly and accurately and in compliancewith the Principles of Good Clinical LaboratoryPractice?Are they responsible for the quality of their data?

1.3.3

Analytical Project Manager’sResponsibilities

1.2

Did the Analytical Project Manager agree to theanalytical plan and any amendments to the planby dated signature?

1.2.1

Does the Analytical Project Manager ensure thatthe procedures specified in the analytical planare followed, assess and document the impactof any deviations from the analytical plan on thequality and integrity of analysis, and takeappropriate corrective action if necessary?Are deviations from the SOP’s during theconduct of the study acknowledged by theAnalytical Project Manager?

1.2.2

Does the Analytical Project Manager ensure thatanalytical plans and amendments and SOP’sare available to study personnel?

1.2.3

Does the Analytical Project Manager sign anddate the analytical report, to indicate acceptanceof responsibility for validity of the results and toconfirm compliance with Good ClinicalLaboratory Practice?

1.2.4

1.2.5 Does the analytical Project Manager ensure thatwhen analytical results are issued are onlyissued under the dated signature of anauthorised signatory?

Does the Analytical Project Manager ensure thatafter completion (including termination) of theanalytical phase, the analytical plan, the finalreport, raw data and supporting material arearchived?

1.2.6

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FACILITIES3

Is the laboratory of suitable size, constructionand locations to meet the requirements of theanalytical phase and to minimise disturbancethat would interfere with the validity of the test?

Is the laboratory environment of such a naturethat it does not invalidate test results?

Where relevant, is this monitored?

3.1

QUALITY ASSURANCE PROGRAMME2

2.1.1 Does the test facility have a documented QualityAssurance Programme to ensure that studiesperformed are in compliance with the Principlesof Good Clinical Practice?Facilities, systems, equipment, methods, QCprocedures, personnel, reports anddocumentation should be audited at intervalsfollowing a prearranged programme.

2.1.2 Are audits conducted by a competent person(s)designated by, and directly responsible tomanagement and who is familiar with the testprocedures?

2.1 General

2.1.3 Is this individual(s) free of involvement in theconduct of the analytical phase being assured?

2.2.3 Do the QA personnel prepare and sign astatement, to be included with the final report,which specifies activities inspected and theirdates, to confirm that those activities arecompliant with guidelines?

Do the QA personnel promptly report anyinspection results in writing to the test sitemanagement and to the Analytical Projectmanager?

2.2.2

Do the QA personnel conduct inspections todetermine if all studies are conducted inaccordance with the Principles of Good ClinicalPractices?Do they determine through inspections thatanalytical plans and SOP’s have been madeavailable to analytical phase personnel and arebeing followed?Are records of such inspections retained?

2.2.1

2.2 Responsibilities of the Quality AssurancePersonnel

Are corrective actions implemented withinagreed time scale?

2.1.5

Is Analytical Project Manager and Test Sitemanagement respond to these audit reports in atimely manner?

2.1.4

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Are suitable arrangements for the disposal of thetoxic waste made with approved contractors?

Are there specialised disposal proceduresapproved by the directorate of radiation controland with the Department of Health Directorate -Radiation Control?

5.4

5.3

3.2 Does the design of the laboratory provide anadequate degree of separation of the differentactivities to assure the proper conduct of thetrial?

3.3 Does the laboratory have a sufficient numberof rooms or areas to assure the isolation ofdifferent types of tests

3.4 Are there storage rooms or areas as needed forsupplies and equipment?Are these separated to avoid cross-contamination and/or deterioration?

3.5 To prevent contamination or mix-ups, are thereseparate rooms or areas for receipt and storageof the test and reference items, and for themixing of the test items with a vehicle?

3.6 Are suitable facilities available for thepreparation of trial supplies in order to ensureaccurate preparation of such materials?

3.7 Are the storage rooms adequate to preserveidentity,concentration, purity and stability, and toensure safe storage for hazardous substances.

4 ARCHIEVE FACILITIES

4.1 Are achieve facilities provided for the securestorage and retrievel of analytical plans, rawdata, final reports, samples of test items andspecimens?

Does the archives design and conditionsprotect the contents from untimely deteriation?

Does the archive facilities protect contents fromfire, water and theft?

(This also apply to third party contract archive)

5 WASTE DISPOSAL

5.1 Is the handling and disposal of wastes carriedout in such a way that the integrity of studies isnot jeopardised?(This includes provision for appropriatecollection, storage and disposal facilities, anddecontamination and transportationprocedures)

5.2 Is there a documented policy on discardingeffluent directly into the municipal waste and isthe simultaneous flow of water into the wastepipe adequate to flush it away?

Is all contaminated material sterilised in anautoclave before disposal or put in specialisedcolour coded containers and bags anddispatched to a special contractor contracted forthis purpose?

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6.1

Is the apparatus (including validatedcomputerised systems) used for the generation,storage, and retrieval of data, and for controllingenvironmental factors relevant to the study,suitably located and of appropriate design andadequate capacity?

6.1.2 Is the apparatus used in a study periodicallyinspected, cleaned, maintained and calibratedaccording to SOP’s?Are records of these activities maintained?Is calibration, where appropriate, traceable tonational or international standards ofmeasurement?

6.1.3 Is equipment service schedule maintained thatlist all relevant items of equipment and scheduleof planned service and calibration activities?

6.1.4 Are equipments that are out of service for anyreason clearly marked?

6.1.5 Are equipment users qualified, trained andapproved to operate the equipments?

6.2 MATERIALS

6.2.1 Does the apparatus and materials used in astudy interfere adversely with trial materials,i.e.are they fit for purpose?

7 TRIAL MATERIALS

7.1.1 Are records maintained of analytical phasematerials and reference item date of receipt andexpiry date?

EQUIPMENT AND MATERIALS6

Equipment

6.1.1

7.1 Receipt, Handling, Sampling and Storage

7.1.2 Are handling, sampling and storage proceduresidentified in order that the homogeanity andstability are assured to the degree possible andcontamination or mix-up are precluded?

7.1.3 Do storage container(s) carry identificationinformation, expiry date, and specific storageinstructions?

7.1.4 Are storage areas monitored where controlledconditions are required to maintain the intergrityof trial materials and trial samples?

8 STANDARD OPERATING PROCEDURES

8.1 Does the test site have management approvedwritten SOPs intended to ensure the quality andintegrity of the data generated by that test site?

Are SOPs reviewed periodically?Are revisions to Sop’s approved by the trialfacility management?

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Is there a list of current Standard OperatingProcedures which include the version numbers.Is the list current and up to date?

Are deviations from SOP’s related to theanalytical phase documented, andacknowledged by the Investigator and theAnalytical Project Manager, as applicable?

8.2

8.5 Are SOP’s available for, but not limited to, thefollowing categories of test facility activities (thedetails given under each heading are to beconsidered as illustrative examples?):

8.5.1 Trial SuppliersSupply, preparation, labelling, handling,shipment and storage

8.5.2 EquipmentOperation, maintenance, cleaning andcalibration of equipment.

8.5.3 Record Keeping, Reporting, Storage andRetrievalCoding of trials, data collection, preparation ofreports, indexing systems, handling of data,including the use of computerised data systems,and operation of the archive.

9 PREPARATION OF TRIAL PACKS

9.1 Procedures for receipt, transfer, identificationand care of trial materials and samples.

10 PROCEDURE FOR THE ANALYSIS OF TRIALsamples

Does each separate test site unit or area haveimmediately available current SOP’s relevant tothe activities being performed therein?(Published text books, analytical methods,articles and manuals may be used assupplements to these SOP’s)

8.4

10.1 Quality Audit ProceduresOperation of Quality Assurance personnel inplanning, scheduling, performing, documentingand reporting audits, inspections, andanalytical report reviews.

10.2.1 The QC procedures operated by test site toensure the quality and accuracy of results.

11 PLANNING OF THE WORK

11.1.1 Does a written plan exist prior to the initiation ofthe work?Is the analytical plan approved by datedsignature of the Analytical Project Manager andthe Sponsor, and as appropriate theInvestigator?Is the analytical plan retained as part of therecords for the trial?

8.3

10.2 Quality Control Procedure

11.1 Analytical Plan

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11.3.2 The proposed starting and completion dates forthe work.

The date of approval of the analytical plan bysignature of the Analytical Project Manager,Investigator and the Sponsor.

11.3.1

Dates11.3

Name and address of the Analytical ProjectManager and the phases of the study delegatedby the Investigator/sponsor

11.2.9

11.2.8 Name and address of the Investigator

11.2.7 Name and address of any trial facility

11.2.6 Name and address of the sponsor.

Information Concerning the Sponsor and TrialFacility

11.2.5

A unique identifier that link the work within theanalytical plan to the trial protocol whilstretaining the chain of custody and identity of alltrial samples.

11.2.4

A statement which reveals the nature andpurpose of the test.

11.2.3

11.2.2 A descriptive title.

The analytical plan should be sufficientlydetailed to provide clear instruactions to thoseundertaking the work and contain, but not limitedto the following information:

11.2.1

11.2 Content of the Analytical Plan

Are deviations from the analytical plandescribed, explained, acknowledged and datedin a timely manner by the Analytical ProjectManager, Investigator and Sponsor andmaintained with the study raw data?

11.1.3

11.1.2 Are amendments to the analytical plan justifiedand approved by dated signatures of theAnalytical Project Manager, Investigator andSponsor and maintained with the analyticalplan?

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Records

11.5.2 Method of reporting results

11.5

A list of records to be retained and their locationon completion of the work.

11.5.1

Quality Audit11.6

11.6.1 The Quality Audit to be performed to assure thequality and integrity of the data generated andthe accuracy of its reporting

12 CONDUCT OF THE ANALYTICAL WORK

12.1 Is the analytical phase conducted in accordancewith the analytical plan?

12.2 Are all data generated during the conduct of theanalytical phase recorded directly, promptly,accurately, and legibly by the individual enteringthe data, and have all entries been signed orinitialled and dated?

11.4.1 Reference to published analytical methods.This should detailed information on theanalytical design, methods, materials andconditions, type and frequency of analysis,measurements, observations and examinationsto be performed.

11.4 Analytical Process

11.4.2 The preparation and shipment of materialssuch as sample kits to be used in the collectionof trial materials must be covered by analyticalplan. A separate plan for the preparation of trialpacks could be produced or such logisticscould be included in the analytical plan.

11.4.3 The type and number of trial materials to bereceived by the trial facility

11.4.4 The method or procedure and conditions underwhich trial materials are transported from onelocation to another

11.4.5 For “blinded” or “coded” trials the conditions ofblinding and the unblinding procedure to befollowed

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Method Validation12.6

Is there a procedure that address the securityand operation of the computer systems. Thefollowing to be included: maintenance of a dataaudit trial, which include date/time and individualresponsible for the collection of the data, systemchange control procedures, maintenance andsystem security procedures.

12.6.1

12.6.4 Are validation records of analytical methodsavailable?

12.6.5 Are analytical methods changed withconsultation and agreement with the sponsor.Are those changes controlled, documented,approved by the sponsor and validated?

12.6.2 Is there an access control system?

12.6.3 Is electronic data protected?

Are any changes in the raw data made so as notto obscure the previous entry and have thereasons for the changes been indicated, anddated and signed?

12.3

Is data generated as a direct computer inputidentified at the time of data input by theindividual(s) responsible for direct data entries?Does computerised system design provide forthe retention of full audit trails to show allchanges to the data without obscuring theoriginal data? (It should be possible toassociate all changes to data with the personshaving made these changes, for example, byuse of timed and dated (electronic signatures).Are the reasons for the changes given?

12.5.1 Are computer systems appropriately validatedand maintained and demonstrably fit forpurpose.

12.5 Computer Systems

12.5.2 Are computerised systems used to receive,capture, process or report data acquired,developed, tested, released, used andmaintained according to establishedguidelines,this may include the FDA 21CRFPart 11: Electronic Records, ElectronicSignatures, Rule and FDA Guidelines for theuse of computer systems in the conduct ofclinical trials.

12.5.3 Is there a procedure that address the securityand operation of the computer systems. Thefollowing to be included: maintenance of a dataaudit trial, which include date/time andindividual responsible for the collection of thedata, system change control procedures,maintenance and system security procedures.

12.5.4 Is there access control system?

12.5.5 Is electronic data protected?

12.4

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Are trial materials analysed and reported withina time frame consistent with patient safetyissues and trial protocol, analytical plan,Standard Operating Procedure and anycontractual material?

12.7.1

12.7 Processing Trial Materials

12.8 Repeat Analysis

12.8.1 Are specific rules covering the performance ofrepeat analysis documented?

12.8.2 Is the laboratory having documented proceduresgoverning rules for repeat analysis consistentwith international standards?

12.8.3 Are there documented repeat records,authorised by the analytical Project Manager?

12.9 Quality Controls

12.9.1 Does the test site operate appropriate QualityControl procedures to ensure the quality andaccuracy of all aspects of the work performedand reported?

12.9.2 Has the test site subscribed to membership ofProficiency shemes to demonstrate thecompetency of the work performed?

12.10.1 Are laboratory procedures take into accountlocal registration and Standard practise inaddressing the safe handling of hazardoussubstances and trial materials?

(a) Handling of Hazardous Materials

Safety12.10

Are special precautions taken when working withknown hazardous (carcinogenic, toxic, addictive)chemicals, according to a written procedure?

Is there a designated area where suchchemicals are stored and where the person incharge of the laboratory controls access?

Are all hazardous chemicals properly labelled?

Are staff aware of the hazardous properties of allsuch chemicals?

Are there documented procedures for the safehandling of these chemicals?

Are there documented emergency treatmentprotocols in the laboratory for accidentalcontamination by these materials andchemicals?

Are such chemicals stored correctly and whennecessary under lock and key?

Is the handling of radioactive substances in thelaboratory documented?

Does the laboratory have all necessary licencesto handle radioactive material where required?

Is the laboratory checked regularly forbackground radiation?

Are the staff well versed in the handling of andprecautions to be taken when using suchradioactive material?

(i)

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

(viii)

(ix)

(x)

(Xi)

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REPORTING OF ANLYTICAL RESULTS

13.1.1 Is a final report prepared for each phase?(There are two basic: Analytical report andanalytical results. The analytical plan shouldindicate the type of reporting mechanism to befollowed and the time scale for issue of any suchdocuments)

13

General13.1

13.1.2 Is the type of report agreed between theAnalytical Project Manager, Investigator andSponsor?

13.2

Were results reviewed (Quality Control review)to ensure the accuracy of the informationproduced?

13.2.1

Did the Analytical Project Manager submitcopies of analytical reports or analytical resultsto the investigator? Are these reports retained atthe test site?

Issue of reports

13.2.2

(b) Are biohazard cabinets used in thelaboratory when:

Hazardous bacteria, fungi or viruses arehandled?

Specimens containing such biohazardousmicroorganisms are decanted?

Are adequate fume cupboards provided forworking with obnoxious fumes?

Are adequate laminar flow cabinets providedwhere necessary?

Is a safety procedure available for the handlingof pipettes when dealing with infected materialsand with corrosive chemicals?

Are there specialised containers anddocumented procedures for the disposal ofsharps i.e. sharp instruments that are used inthe laboratory such as needles, glass and soon?

Are documented procedures in place to preventinjury to staff by cutting instruments?

(i)

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

12.11 Subcontracting

12.11.1 Is there evidence that subcontracted/refferedwork was approved by the sponsor?

12.11.2 Where the subcontract was the choice of thetest site, is test site management responsible tothe sponsor for sub-contracted/referred work?

12.11.3 Prior to placement of sub-contracted/refferedwork, did the test site confirmed that thesubcontractor will work according to GoodClinical Laboratory Practice and any trialrequirements?

12.11.4 Does the contract for sub-contracted/refferedwork clearly specify the detail of analysis and theretention of trial data?

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Dates

Experimental starting and completion dates.

A Quality Audit Certificate

Description of Materials and Test Methods usedincluding data manipulation techniques and any

Presentation of results:All information and data required by theanalytical plan.

Results

The location(s) where the analytical plan,specimens required to be retained, raw dataand the final report are to be stored.

Storage

Statement

13.6.1

13.6

13.7.1

13.7.2

13.8

13.8.1

13.9.113.9

13.7

13.3.1 Is the analytical report signed and dated by theAnalytical Project Manager to indicateacceptance of responsibility for the validity ofthe data?Is the extent of compliance with GCP principlesindicated?

13.3 Analytical report

13.3.2 Are corrections and additions to a final reportmade in the form of amendments, and do suchamendments clearly specify the reason(s) forthe corrections or additions and are theysigned and dated by the Analytical ProjectManager?

(Reformatting of the final report to comply withthe submission requirements of a nationalregistration or regulation authority does notconstitute a correction, addition or amendmentto the final report).

13.4.1 Does the final report contain at least thefollowing information:

13.4 Content of the Analytical Report

Identification of the analytical work, bydescriptive title and identification number?

13.5 Information concerning the Sponsor andthe Test Facility

Name and address of the sponsor.

Name and address of test site and anyinvestigator sites involved including identifyinginvestigator.

Name and address of the Investigator.

Name and address of the Analytical ProjectManager and the phase(s) of the studydelegated, if applicable.

13.5.1

13.5.2

13.5.3

13.5.4

OECD Document on Study Director

The clinical trial number?

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13.10.1

13.10.2

13.10.3

13.10.4

13.10.5

13.10.6

13.10.7

13.10.8

13.10.9

Analytical results should be appropriately andaccurately reported. Does the analytical resultscontain at least the following information:

Identification of the analytical work by uniqueidentification number

Te clinical trial number

Identity of Sponsor

Identity of test site and the investigator towhom the results are directed

Name of Analytical Project Manager

Presentation of the results

Date and signature of authorised signatory

Are amended analytical results clearlyindicating that the results have been amendedand the reasons for such changes

13.10 Analytical Results

14 STORAGE AND RETENTION OF RECORDSAND MATERIALS

14.1

14.2

14.3

14.4

14.5

14.6

Have the following been retained in thearchives for the period specified by theappropriate authorities?:

The analytical plan, raw data,samples/specimens analytical results and thefinal analytical report.

Records of all audits performed by the QualityAudit Function.

Records of qualifications, training, experienceand job descriptions of personnel.

Records and reports of the maintenance andcalibration of equipment.

Validation documentation for computerisedsystems.

14.7 The records of all QC test and results performedto confirm the accuracy of the work performed

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14.9 Environmental monitoring records

14.10 In the absence of a required retention period,the final disposition of any study materialsshould be documented. When samples of testand reference items and specimens aredisposed of before the expiry of the requiredretention period for any reason, this should bejustified and documented. Samples/specimensshould be retained only as long as the quality ofthe preparation permits evaluation.

Is the material contained in the archives indexedso as to facilitate orderly storage and retrieval?

14.11

Is access to the archives limited to onlypersonnel authorised by the management?Is movement of material in and out of thearchives properly recorded?

14.12

14.8 The historical file of all SOP’s

14.13 Is there a documented procedure for thetransfer of material stored in the test facilityarchives to the archives of the sponsor(s) ofthe study(s), should the test facility go out ofbusiness and has no legal successor?

15 CONFIDENTIALITY

15.1 Are procedures for the handling of trialmaterials, collection of data and reporting ofresults designed to maintain confidentiality?

15.2 Are procedures such that they assure that asponsor’s proprietary information is notdisclosed to anyone other than authorisedindividuals?


Signed:

Lead Inspector /InspectorTechnical Expert

Date:(dd/mm/yyyy) / /

48777

SANAS CHECKLIST FOR GCLP - South African National ...2008-4-7 · F102-02 2008-03-27 © SANAS...

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Transcript of SANAS CHECKLIST FOR GCLP - South African National ...2008-4-7 · F102-02 2008-03-27 © SANAS...