good laboratory practice regulatio s 2008. - trree

ATIOAL AGECY FOR FOOD AD DRUGADMIISTRATIO AD COTROL ACT 1993(AS AMEDED)GOOD LABORATORY PRACTICE REGULATIOS 2008.CommencementIn exercise of the powers conferred on the Governing Council of the NationalAgency for Food and Drug Administration and Control (NAFDAC) by sections 5and 29 of NAFDAC Act 1993 (as amended) and all the powers enabling it in thatbehalf, the Governing Council of NAFDAC with approval of the HonourableMinister of Health makes the following Regulations:1. These regulations prescribe Good Laboratory Practice for conducting nonclinicalstudies for the purpose of obtaining marketing authorisation for allproducts regulated by the Agency including pharmaceuticals, cosmeticproducts, medical devices, food, packaged water, food and feed additives,pesticides, veterinary products, chemicals and similar products. The scopeincludes work conducted in the laboratory, in green houses and in thefield.Scope2. The provisions of these regulations shall apply to a sponsor conducting anon-clinical laboratory study on regulated products intended to besubmitted to or reviewed by the Agency for marketing authorization andutilizes the services of a consulting laboratory, contractor or grantee toperform an analysis or other services, the consulting laboratory, contractoror grantee shall comply with the provisions of these regulations:-Applicabilityto subcontractingstudies3. (1) A test facility shall permit authorized employees of the Agency, toinspect the facility and to inspect (and in the case of records also to copy)all records and specimens required to be maintained regarding non-clinicalstudies within the scope of these Regulations.Inspectionof a testFacility(2) The Agency shall not consider a non-clinical laboratory study insupport of an application for marketing authorisation if the test facilityrefuses to permit inspection. Where a non-clinical study will not beconsidered for marketing authorisation, the applicant shall not beexempted from the statutory requirement of submitting the result of thestudy to the Agency.1

4. a. Each individual engaged in the conduct of or responsible for thesupervision of a non-clinical study shall have education, training, andexperience, or combination thereof, to enable that individual to perform theassigned functions.OrganizationandPersonnelb. Each test facility shall maintain a current record of qualifications, training,experience and job description for each individual engaged in orsupervising the conduct of a non-clinical study.c. There shall be a sufficient number of adequately qualified and experiencedpersons for the timely and proper conduct of the non-clinical studyaccording to the study pland. Ensure that personnel clearly understand the functions they are to performand, where necessary, provide training for those functions;e. Ensure that there is a quality assurance programme with designatedpersonnel and ensure that the quality assurance programme is beingperformed in accordance with the principles of Good Laboratory Practicef. Ensure that for each non-clinical study an individual with the appropriatequalifications, training and experience is designated by the management asthe study director before the non-clinical study is initiated. Replacement ofa study director shall be done according to established procedures, andshall be documented;g. Ensure, in the event of a multi-site non-clinical study, that, if needed, aprincipal investigator is designated, who is appropriately trained, qualifiedand experienced to supervise any delegated phase of the study.Replacement of the principal investigator shall be done according toestablished procedures, and shall be documented;h. Ensure for a multi-site non-clinical study that clear lines ofcommunication exist between the study director, principal investigator,quality assurance programme and personnel;i. Provide adequate supervision of study personnel including trainees bypersons familiar with methods and procedures of the non-clinical study.j. The test facility shall use personnel who are employed or under contract tothe facility. Where contracted and additional technical and key supportpersonnel are used, the test facility shall ensure that such personnel aresupervised, competent and they work in accordance with the provisions ofthese regulations.k. Personnel shall take necessary sanitation and health precautions forpersonal safety and to avoid contamination of test systems and test andreference items.l. Personnel engaged in a non-clinical study shall wear clothing appropriatefor the duties they perform. Such clothing shall be changed as often asnecessary to prevent microbiological, radiological, or chemicalcontamination of self, test systems and test and reference items.2

m. Any individual found at any time to have an illness that may adverselyaffect the quality and integrity of the non-clinical study shall be excludedfrom direct contact with test systems, test and reference items and anyother operation or function that may adversely affect the non-clinical studyuntil the condition is corrected. All personnel shall be instructed to reportto their immediate supervisors any health or medical conditions that mayreasonably be considered to have an adverse effect on a non-clinical study.5. a Each non-clinical study shall be under the authority of the test facilitymanagement who shall be responsible for the organisation and functioning of thetest facility in accordance with principles of Good Laboratory Practice.Test FacilityManagementb. The facility management shall ensure that a statement exists which identifiesthe individual within a test facility who shall fulfil the responsibility of themanagement as defined by the principles of Good Laboratory Practicec. Designate a study director as prescribed in section 6 before the non-clinicalstudy is initiated.d. Replace the study director promptly if it becomes necessary to do so duringthe conduct of a non-clinical study according to established procedures, andthis shall be documentede. Ensure that personnel, resources, facilities, equipment, materials, andmethodologies are available as scheduledf. Ensure that personnel clearly understand the functions they are to performg. Ensure that there is a quality assurance programme as prescribed in section7.h. Ensure that test and reference items or mixture have been appropriatelytested for identity, strength, purity, stability and uniformity as applicablei. Ensure that any deviations from these regulations reported by the qualityassurance unit are communicated to the study director and corrective actionsare taken and documented.6. a. For each non-clinical study, a scientist or other professional of appropriateeducation, training, and experience, or combination thereof, shall beidentified as the study director. The study director has overallresponsibility for the technical conduct of the non-clinical study, as well asfor the interpretation, analysis, documentation and reporting of results, andrepresents the single point of study control.The Studydirector’Responsibilities.b. The following are the functions of the study directors;i. Approve the study plan and any amendments to the study plan by datedsignature3

ii. Ensure that the Quality Assurance personnel have a copy of the study planand any amendments in a timely manner and communicate effectively withthe Quality Assurance personnel as required during the conduct of the nonclinicalstudy.iii. Ensure that study plans and amendments and Standard Operating Proceduresas prescribed in section 11 are available to study personnel;iv. Ensure that the study plan and the final report for a multi-site study identifyand define the role of any Principal Investigator(s) and any test facilitiesand test sites involved in the conduct of the non-clinical study;v. Ensure that:a. The procedures specified in the study plan are followed,b. Assess and document the impact of any deviations from the studyplan on the quality and integrity of the non-clinical studyc. Take appropriate corrective action if necessaryd. Acknowledge deviations from Standard Operating Proceduresduring the conduct of the non-clinical studyvi. Ensure that all raw data generated are fully documented and recorded;vii Ensure that computerised systems used in the non-clinical study havebeen validated;viii. Sign and date the final report to indicate acceptance of responsibility forthe validity of the data and to indicate the extent to which the nonclinicalstudy complies with these Principles of Good LaboratoryPractice;ix. Ensure that after completion (including termination) of the non-clinicalstudy, the study plan, the final report, raw data and supporting materialare archived.7. a. A test facility shall have a quality assurance unit which shall beresponsible for monitoring each study to assure management that thefacilities, equipment, personnel, methods, practices, records, and controlsare in conformance with the regulations. For any given study, the qualityassurance unit shall be entirely separate from and independent of thepersonnel engaged in the direction and conduct of that study.QualityassuranceProgrammeb. The responsibilities of the Quality Assurance personnel shall include, butnot limited to the following:i. Maintain copies of all approved non-clinical study plans andStandard Operating Procedures in use in the test facility and haveaccess to an up-to-date copy of the master schedule;ii. Verify that the non-clinical study plan contains the informationrequired for compliance with the Principles of Good LaboratoryPractice. This verification shall be documented;iii. Conduct inspections to determine if all non-clinical studies areconducted in accordance with the Principles of Good Laboratory4

Practice. Inspections shall also determine that study plans andStandard Operating Procedures have been made available to studypersonnel and are being followed. Inspections can be of three typesas specified by Quality Assurance Programme Standard OperatingProcedures:a. Study-based inspections,b. Facility-based inspections,c. Process-based inspections.Records of such inspections shall be retained.iv. Inspect the final reports to confirm that the methods, procedures, andobservations are accurately and completely described, and that thereported results accurately and completely reflect the raw data of thenon-clinical studies;v. Promptly report any inspection results in writing to management, tothe Study Director, the Principal Investigator(s) and the respectivemanagement, when applicable;vi. Prepare and sign a statement, to be included with the final report,which specifies types of inspections and their dates, including thephase(s) of the study inspected, and the dates inspection results werereported to the management and the Study Director and PrincipalInvestigator(s), if applicable. This statement would also serve toconfirm that the final report reflects the raw data.8. Each test facility shall be of suitable size and construction to facilitate theproper conduct of non-clinical studies. It shall be designed so that there is adegree of separation that will prevent any function or activity from having anadverse effect on the non-clinical study.Facilityi. The test facility shall have a sufficient number of rooms or areas to ensure theisolation of test systems and the isolation of individual projects, involvingsubstances or organisms known to be or suspected of being biohazardous.ii. Suitable rooms or areas shall be available for the diagnosis, treatment andcontrol of diseases, in order to ensure that there is no unacceptable degree ofdeterioration of test systemsiii. There shall be storage rooms or areas as needed for supplies and equipment.Storage rooms or areas shall be separated from rooms or areas housing the testsystems and shall provide adequate protection against infestation,contamination, and/or deterioration.iv. To prevent contamination or mix-ups, there shall be separate rooms or areasfor receipt and storage of the test and reference items, and mixing of the testitems with a vehicle.v. Storage rooms or areas for the test items shall be separate from rooms or areascontaining the test systems. They shall be adequate to preserve identity,5

concentration, purity, and stability, and ensure safe storage for hazardoussubstances.vi. Archive facilities shall be provided for the secure storage and retrieval ofstudy plans, raw data, final reports, samples of test items and specimens.Archive design and archive conditions shall protect contents from untimelydeterioration.vii. Handling and disposal of wastes shall be carried out in such a way as not tojeopardise the integrity of non-clinical studies. This includes provision forappropriate collection, storage and disposal facilities, and decontaminationand transportation procedures.viii. A test facility shall have a sufficient number of animal rooms or areas, asneeded, to ensure proper:a. Separation of species or test systemsb. Isolation of individual projectsc. Quarantine of animals, andd. Routine or specialized housing of animals.ix. A test facility shall have a number of animal rooms or areas separate fromthose prescribed in section 8 (i) to ensure isolation of studies being done withtest systems or test and reference items known to be bio-hazardous, includingvolatile substances, aerosols, radioactive materials, and infectious agents.x. Separate areas shall be provided, as appropriate, for the diagnosis, treatment,and control of laboratory animal diseases. These areas shall provide effectiveisolation for the housing of animals either known or suspected of beingdiseased, or of being carriers of disease, from other animals.xi. When animals are housed, facilities shall exist for the collection and disposalof all animal waste and refuse or for safe sanitary storage of waste beforeremoval from the test facility. Disposal facilities shall be so provided andoperated as to minimize vermin infestation, odours, disease hazards, andenvironmental contamination.xii. There shall be storage areas, as needed, for feed, bedding, supplies, andequipment. Storage areas for feed and bedding shall be separated from areashousing the test systems and shall be protected against infestation orcontamination. Perishable supplies shall be preserved by appropriate means.9. Equipment used in the generation, measurement, or assessment of data andequipment used for facility environmental control shall be of appropriate designand adequate capacity to function according to the study plan and shall be suitablylocated for operation, inspection, cleaning, and maintenance.Equipmentand Computersystems10. a. Equipment shall be adequately inspected, cleaned, and maintained.Equipment used for the generation, measurement, or assessment of data shall beadequately tested, calibrated and/or standardized.Maintenanceand calibrationof equipment6

. The written standard operating procedures shall set forth insufficient detail the methods, materials, and schedules to be usedin the routine inspection, cleaning, maintenance, testing,calibration, and/or standardization of equipment, and shallspecify, when appropriate, remedial action to be taken in theevent of failure or malfunction of equipment.(c) The written standard operating procedures shall designate the personresponsible for the performance of each operation.(d) The written records shall be maintained of all inspection, maintenance,testing, calibrating and/or standardizing operations. These records, containingthe date of the operation, shall describe whether the maintenance operationswere routine and followed the written standard operating procedures.(e) The written records shall be kept of non-routine repairs performed onequipment as a result of failure and malfunction. Such records shall documentthe nature of the defect, how and when the defect was discovered, and anyremedial action taken in response to the defect.11. a. A test facility shall have written standard operating procedures approvedby test facility management that are intended to ensure the quality andintegrity of the data generated by the test facility. Revisions to standardoperating procedures shall be approved by test facility management.StandardsOperatingProceduresb. Standard operating procedures shall be available for, but not be limited to,the following categories of test facility activities. The details given undereach heading are to be considered as illustrative examples -i. Test and reference itemsreceipt, identification, labelling, handling, sampling and storage;ii.iii.iv.Equipment, materials and reagentsequipment: use, maintenance, cleaning and calibration,computerised systems: validation, operation, maintenance,security, change control and back-up,materials, reagents and solutions: preparation and labelling;Record keeping, reporting, storage, and retrievalcoding of studies, data collection, preparation of reports, indexingsystems, handling of data, including the use of computerised datasystems;Test system (where appropriate)Room preparation and environmental room conditions for the testsystem7

procedures for receipt, transfer, proper placement,characterisation, identification and care of test system,Test system preparation, observation and examinations,before, during and at the conclusion of the non-clinicalstudy,Handling of test system individuals found moribund ordead during the non-clinical study,Collection, identification and handling of specimensincluding necropsy and histopathology,Siting and placement of test systems in test plots;v. Quality assurance proceduresoperation of quality assurance personnel in planning, scheduling,performing, documenting and reporting inspections.c. Each laboratory area shall have immediately available laboratory manualsand standard operating procedures relative to the laboratory proceduresbeing performed. Validated published articles and methods may be used asa supplement to standard operating procedures.d. A historical file of standard operating procedures, and all revisionsthereof, including the dates of such revisions, shall be maintained.12. All reagents and solutions in the laboratory areas shall be labelled toindicate identity, titre or concentration, storage requirements, and expirationdate. Deteriorated or outdated reagents and solutions shall not be used.Reagents andsolutions13 a. There shall be standard operating procedures for the housing, feeding,handling, and care of animals.Animal careb. Newly received animal and plant test systems shall be isolated until theirhealth status has been evaluated. If any unusual mortality or morbidity occurs,this lot shall not be used in non-clinical studies and, when appropriate, shallbe humanely destroyed.c. At the initiation of a non-clinical study, animals shall be free of any disease orcondition that might interfere with the purpose or conduct of the study. If,during the course of the study, the animals contract such a disease orcondition, the diseased animals shall be isolated, if necessary. These animalsmay be treated for disease or signs of disease provided that such treatment8

does not interfere with the study. The diagnosis, authorizations of treatment,description of treatment, and each date of treatment shall be documented andshall be retainedd. Records of source, date of arrival, and arrival condition of test systems shallbe maintained.e. Biological test systems shall be acclimatised to the test environment for anadequate period before the first administration/application of the test orreference item.f. All information needed to properly identify the test systems shall appear ontheir housing or containers. Individual test systems that are to be removedfrom their housing or containers during the conduct of the non-clinical studyshall bear appropriate identification, wherever possible.g. Warm-blooded animals, excluding suckling rodents, used in laboratoryprocedures that require manipulations and observations over an extendedperiod of time or in non-clinical studies that require the animals to be removedfrom and returned to their home cages for any reason (e.g., cage cleaning,treatment, etc.), shall receive appropriate identification. All informationneeded to specifically identify each animal within an animal-housing unitshall appear on the outside of that unit.h. Animals of different species shall be housed in separate rooms whennecessary. Animals of the same species, but used in different studies, shall notordinarily be housed in the same room when inadvertent exposure to referenceor test items or animal mixup could affect the outcome of either study. If suchmixed housing is necessary, adequate differentiation by space andidentification shall be made.i. During use, housing or containers for test systems shall be cleaned andsanitised at appropriate intervals. Any material that comes into contact withthe test system shall be free of contaminants at levels that would interfere withthe study.j. Bedding for animals shall be changed as required by sound husbandrypractice.k. Animal cages, racks and accessory equipment shall be cleaned and sanitized atappropriate intervals.l. Feed and water used for the animals shall be analyzed periodically to ensurethat contaminants known to be capable of interfering with the study andreasonably expected to be present in such feed or water are not present atlevels above those specified in the study plan. Documentation of suchanalyses shall be maintained as raw datam. Bedding used in animal cages or pens shall not interfere with the purpose orconduct of the non-clinical study and shall be changed as often as necessary tokeep the animals dry and cleann. If any pest control materials are used, the use shall be documented. Cleaningand pest control materials that interfere with the non-clinical study shall not beused.9

14. Records including test item and reference item characterisation, date ofreceipt, expiry date, quantities received and used in non-clinical studies shall bemaintained.Test andreference Items15. a. Handling, sampling, and storage procedures shall be identified in order thatthe homogeneity and stability are assured to the degree possible andcontamination, deterioration, damage or mix-up are precluded.Receipt, handling,sampling andstorageb. Storage containers shall carry identification information, expiry date, andspecific storage instructions necessary to maintain the identity, strength,purity and composition of the test or reference item.16. a Each test and reference item shall be appropriately identified (e.g. code,chemical abstracts service registry number (CAS number), name, biologicalparameters etc.).Characterisationb. For each non-clinical study, the identity, including batch number, purity,composition, concentrations, or other characteristics to appropriately defineeach batch of the test or reference items shall be known.c. In cases where the test item is supplied by the sponsor, there shall be amechanism, developed in co-operation between the sponsor and the testfacility, to verify the identity of the test item subject to the non-clinical study.d. Methods of synthesis, fabrication or derivation of the test and reference itemsshall be documented by the sponsor or test facilitye. In those cases where marketed products are used as reference items suchproducts shall be characterized by their labellingf. The stability of test and reference items under storage and test conditions shallbe known for all non-clinical studies.g. If the test item is administered or applied in a vehicle, the homogeneity,concentration and stability of the test item in that vehicle shall be determined.For test items used in field studies (e.g. tank mixes), these may be determinedthrough separate laboratory experiments. Where any of the components of thetest or mixture of reference item and vehicle has an expiration date, that dateshall be clearly shown on the container. If more than one component has anexpiration date, the earliest date shall be shown.h. A sample for analytical purposes from each batch of test item shall be retainedfor the duration of the non-clinical study.i. For non-clinical studies of more than 4 weeks' duration, reserve samples fromeach batch of test and reference items shall be retained for the period of timeprescribed in section 22 (b).10

17. a. For each non-clinical study, a written study plan shall exist prior toinitiation of the study. The study plan shall be approved by dated signature of thestudy director and verified for good laboratory practice compliance by qualityassurance personnel.Study plan forconduct of anon-clinical studyb. With respect to the study plan -i. All changes in or revisions of an approved study plan and thereasons adduced shall be documented, signed by the study director,dated, and maintained with the study plan;ii.Deviations from it shall be described, explained, acknowledgedand dated in a timely fashion by the study director and/or anyprincipal investigator(s) and maintained with the study raw data.c. For short-term non-clinical studies, a general study plan accompanied bya study-specific supplement may be used.18. The study plan shall contain, but not be limited to, the followinginformation -Study plana. Identification of the study, the test item and the reference itemi. A descriptive titleii. A statement which reveals the nature and purpose of the studyiii. Identification of the test item by code or name (IUPAC, CASnumber, biological parameters etc.)iv. The reference item to be usedb. Information concerning the sponsor and the test facilityi. Name and address of the sponsor,ii. Name and address of any test facilities and test sites involved,iii. Name and address of the study director,iv. Name and address of any principal investigator(s), and thephase of the study delegated by the study director to, and underthe responsibility of the principal investigator;c. Datesi. The date of approval of the study plan by signature of the studydirectorii. The proposed experimental starting and completion datesd. Test methods11

i. Reference to the test guideline or method to be used;e. Issues (where applicable)i. The justification for selection of the test system,ii. The characterisation of the test system, such as the species,strain, sub-strain, source of supply, number, body weightrange, sex, age, and other pertinent informationiii. The method of administration and the reason for its choiceiv. The dose levels and/or concentration, frequency, duration ofadministration or applicationv. Detailed information on the experimental design, including adescription of the chronological procedure of the non-clinicalstudy, all methods, materials and conditions, type andfrequency of analysis, measurements, observations andexaminations to be performed, and statistical methods to beused (if any)f. Recordsi. A list of records to be retained.19. a A unique identification shall be given to each non-clinical study. Allitems concerning this study shall carry this identification. Specimens fromthe study shall be identified to confirm their origin. Such identification shallenable traceability, as appropriate for the specimen and study.Conduct ofa non-clinicalstudyb. The study shall be conducted in accordance with the study plan.c. All data generated during the conduct of a non-clinical study, except those thatare generated by automated data collection systems, shall be recorded directly,promptly, and legibly in ink. All data entries shall be dated on the date of entryand signed or initialled by the person entering the data.d. Any change in entries shall be made so as not to obscure the original entry,shall indicate the reason for such change, and shall be dated and signed oridentified at the time of the change.e. In automated data collection systems, the individual responsible for direct datainput shall be identified at the time of data input. Any change in automated dataentries shall be made so as not to obscure the original entry, shall indicate thereason for change, shall be dated, and the responsible individual shall beidentified.12

20 a. A final report shall be prepared for each non-clinical study. In the case ofshort term studies, a standardised final report accompanied by a study specificextension may be prepared.i. Reports of Principal Investigator(s) or scientist(s) involved in the nonclinicalstudyshall be signed and dated by them.ii. The final report shall be signed and dated by the Study Director to indicateacceptance of responsibility for the validity of the data. The extent ofcompliance with the Principles of Good Laboratory Practice shall beindicated.iii. Corrections and additions to a final report shall be in the form ofamendments.Amendments shall clearly specify the reason for the corrections oradditions and shall be signed and dated by the Study Director.iv. Reformatting of the final report to comply with the submissionrequirements of the Agency does not constitute a correction, addition oramendment to the final report.Reportsb. The final report shall include, but not be limited to, the followinginformation:1. Identification of the on-clinical study, the Test Item and ReferenceItemi. A descriptive title;ii. Identification of the test item by code or name (IUPAC, CASnumber, biological parameters, etc.);iii. Identification of the reference item by name;iv. Characterisation of the test item including purity, stability andhomogeneity.2. Information Concerning the Sponsor and the Test Facilityi. Name and address of the sponsor;ii. Name and address of any test facilities and test site(s) involved;iii. Name and address of the Study Director;iv. Name and address of the Principal Investigator(s) and the phase(s)of the study delegated, if applicable;v. Name and address of scientists having contributed reports to thefinal report.3. Datesi. Experimental starting and completion dates.4. Statementi. A Quality Assurance Programme statement listing the types ofinspections made and their dates, including the phase(s) inspected,and the dates any inspection results were reported to managementand to the Study Director and Principal Investigator(s), if13

applicable. This statement would also serve to confirm that thefinal report reflects the raw data.5. Description of Materials and Test Methodsi. Description of methods and materials used;ii. Reference to test guideline or method.6. Resultsi. A summary of results;ii. All information and data required by the study plan;iii. A presentation of the results, including calculations andiv.determinations of statistical significance;An evaluation and discussion of the results, and where appropriate,conclusions.7. Storagei. The location(s) where the study plan, samples of test and referenceitems, specimens, raw data and the final report are to be stored.21. a All raw data, documentation, study plans, final reports, and specimens(except those specimens obtained from mutagenicity tests and wet specimens ofblood, urine, faeces, and biological fluids) generated as a result of a non-clinicalstudy shall be retained.Storage andretrieval ofrecordsand datab. There shall be archives for orderly storage and expedient retrieval of allraw data, documentation, study plans, specimens, and interim and finalreports. Conditions of storage shall minimize deterioration of thedocuments or specimens in accordance with the requirements for the timeperiod of their retention and the nature of the documents or specimens.c. A test facility may contract with commercial archives to provide arepository for all material to be retained. Raw data and specimens may beretained elsewhere provided that the archives have specific reference tothose other locations.d. An individual shall be identified as responsible for the archives.e. Only authorized personnel shall have access to the archives. Movement ofmaterials in and out of the archives shall be properly recorded.f. Material retained or referred to in the archives shall be indexed to permitorderly storage and expedient retrieval.g. If a test facility or an archive contracting facility goes out of business andhas no legal successor, the archive shall be transferred to the archives ofthe sponsor(s) of the non-clinical study(s)22 a . Record retention requirements set forth in this section do not supersedethe record retention requirements of any other section of these regulationsRetentionof records14

. Documentation records, raw data and specimens pertaining to a nonclinicalstudy shall be retained in the archive(s) for whichever of the followingperiods is shortest:i. A period of at least 2 years after the approval date of the marketingauthorisation given by the Agencyii. A period of at least 5 years after submission of non-clinical studyresults required for marketing authorisation to the Agency.iii. In other situations (e.g., where the non-clinical study does notresult in the submission of an application for research or marketingauthorisation), a period of at least 2 years after the date on whichthe study is completed, terminated, or discontinued.iv. Wet specimens (except those specimens obtained frommutagenicity tests and wet specimens of blood, urine, faeces, andbiological fluids), samples of test or reference items, and speciallyprepared material, which are relatively fragile and differ markedlyin stability and quality during storage, shall be retained only aslong as the quality of the preparation affords evaluation. In no caseshall retention be required for longer periods than those set forth inthis section.c. The master schedule sheet, copies of study plans, and records of qualityassurance inspections shall be maintained by the quality assurance unit as aneasily accessible system of records for the period of time prescribed in section22 (a) & (b).d. Summaries of training and experience and job descriptions required to bemaintained by these regulations may be retained along with all other testfacility employment records for the period of time prescribed in section 22(a) & (b)e. Records and reports of the maintenance and calibration and inspection ofequipment shall be retained for the length of time prescribed in section 22(a) & (b).f. Records required by this section may be retained either as original recordsor as true copies such as photocopies, microfilm, microfiche, or otheraccurate reproductions of the original records.g. If a facility conducting non-clinical studies goes out of business, all rawdata, documentation and other materials as prescribed in this section shallbe transferred to the archives of the sponsor of the study. The Agencyshall be notified in writing of such a transfer.23. a The purposes of disqualification are: Disqualificationof TestFacilities15

24.i. To permit the exclusion from consideration of completed nonclinicalstudies that were conducted by a test facility which hasfailed to comply with the requirements of the good laboratorypractice regulations until it can be adequately demonstrated thatsuch non-compliance did not occur during, or did not affect thevalidity or acceptability of data generated by a particular studyii. To exclude from consideration all non-clinical studies completedafter the date of disqualification until the facility can satisfy theAgency that it will conduct studies in compliance with theseregulations.b. The determination that a non-clinical study may not be considered insupport of an application for a research or marketing authorisation doesnot, however, relieve the applicant for such an authorisation of anyobligation under any other applicable regulation to submit the results ofthe study to the Agency.Grounds forDisqualificationThe Agency may disqualify a test facility upon finding all of the following:a. The test facility failed to comply with one or more of the regulations setforth in this part (or any other regulations regarding such facilities in thischapter)b. The non-compliance adversely affected the validity of the non-clinicalstudies; andc. Other lesser regulatory actions (e.g., warnings or rejection of individualnon-clinical studies) have not been or will probably not be adequate toachieve compliance with the good laboratory practice regulations.25.a. Whenever the Agency has information indicating that grounds exist, asprescribed in section 24, which in the opinion of the Agency justifydisqualification of a test facility, the Agency may issue to the test facility awritten notice proposing that the facility be disqualified.b. A regulatory hearing on the disqualification shall be conducted asprescribed by the Agency.otice of andopportunity orhearing onproposeddisqualification.26.a. If the Agency, after the regulatory hearing, or after the time for requestinga hearing expires without a request being made, upon an evaluation of theadministrative record of the disqualification proceeding, makes theFinal order onDisqualification16

findings as prescribed in section 24, the Agency shall issue a final orderdisqualifying the facility. Such order shall include a statement of the basisfor that determination. Upon issuing a final order, the Agency shall notify(with a copy of the order) the test facility of the action.b. If the Agency, after a regulatory hearing or after the time for requesting ahearing expires without a request being made, upon an evaluation of theadministrative record of the disqualification proceeding, does not make thefindings prescribed in section 24, the Agency shall Issue a final orderterminating the disqualification proceeding. Such order shall include astatement of the basis for that determination. Upon issuing a final orderthe Agency shall notify the test facility and provide a copy of the order.27.a. Once a test facility has been disqualified, each application for a researchor marketing authorisation , whether approved or not, containing orrelying upon any non-clinical study conducted by the disqualified testfacility may be examined to determine whether such study was or wouldbe essential to a decision. If it is determined that a study was or would beessential, the Agency shall also determine whether the study is acceptable,notwithstanding the disqualification of the facility.b. Any non-clinical study done by a test facility before or afterdisqualification may be presumed to be unacceptable, and the personrelying on the study may be required to establish that the study was notaffected by the circumstances that led to the disqualification, e.g., bysubmitting validating information. If the study is then determined to beunacceptable, such data shall be eliminated from consideration in supportof the application; and such elimination may serve as new Informationjustifying the termination or withdrawal of approval of the applicationc. No non-clinical study begun by a test facility after the date of the facility'sdisqualification shall be considered in support of any application for aresearch or marketing authorization, unless the facility has been reinstatedprescribed in section 31. The determination that a study may not beconsidered in support of an application for a research or marketingauthorisation does not, however, relieve the applicant for such anauthorisation of any obligation under any other applicable regulation tosubmit the results of the study to the Agency.Actions upondisqualification28.a. Upon issuance of a final order disqualifying a test facilityprescribed in section 26, the Agency may notify all or anyinterested persons.Public disclosure ofinformation regardingdisqualification17

i. Such notice may be given at the discretion of the Agencywhenever it is believed that such disclosure would further publicinterest or would promote compliance with the good laboratorypractice regulations.ii. Such notice, if given, shall include a copy of the final order issuedas prescribed in section 26 and shall state that the disqualificationconstitutes a determination by the Agency that non-clinical studiesperformed by the facility will not be considered by the Agency insupport of any application for a research or marketingauthorisation.iii. If such notice is sent to another Federal GovernmentEstablishment, the Agency will recommend that the establishmentalso consider whether or not it should accept non-clinical studiesperformed by the test facility.iv. If such notice is sent to any other person, it shall state that it isgiven because of the relationship between the test facility and theperson being notified and that the Agency is not advising orrecommending that any action be taken by the person notified.b A determination that a test facility has been disqualified and theadministrative record regarding such determination are disclosable to thepublic.29.a. Disqualification of a test facility under this regulation is independentof, and neither in lieu of nor a precondition to, other proceedings oractions authorized by the Act.b. The Agency may, at any time, institute against a test facility and/ oragainst the sponsor of a non-clinical study that has been submitted tothe Agency any appropriate judicial proceedings (civil or criminal) andany other appropriate regulatory action, in addition to or in lieu of, andprior to, simultaneously with, or subsequent to, disqualification.c. The Agency may also refer the matter to another regulatory or lawenforcement establishment for such action as that establishment deemsappropriate.d. The Agency may refuse to consider any particular non-clinical study insupport of an application for a research or marketing authorization, if itfinds that the study was not conducted in accordance with the goodlaboratory practice set forth in these regulations, without disqualifyingthe test facility that conducted the study or undertaking otherregulatory action.Alternative oradditionalactions todisqualification.18

30.31.a. Termination of a test facility by a sponsor is independent of, and neither inlieu of nor a precondition to, proceedings or actions authorized by thisregulation.b. If a sponsor terminates or suspends a test facility from further participationin a non-clinical study that is being conducted as part of any applicationfor a research or marketing authorization that has been submitted to theAgency, it shall notify the Agency within 15 working days of the action;the notice shall include a statement of the reasons for such action.c. Suspension or termination of a test facility by a sponsor does not relieve itof any obligation under any other applicable regulation to submit theresults of the non-clinical study to the Agency.a. A test facility that has been disqualified may be reinstated as an acceptablesource of non-clinical studies to be submitted to the Agency if the Agencydetermines, upon an evaluation of the submission of the test facility, thatthe facility can adequately ensure that it will conduct future studies incompliance with good laboratory practice set forth in these regulationsand, if any studies are currently being conducted, that the quality andintegrity of such studies have not been seriously compromised.b. A disqualified test facility that wishes to be so reinstated shall present inwriting to the Agency reasons why it believes it should be reinstated and adetailed description of the corrective actions it has taken or intends to taketo ensure that the acts or omissions which led to its disqualification willnot recur.c. The Agency may consider reinstatement upon the test facility being foundin compliance with the good laboratory practice regulations upon aninspection.d. If a test facility is reinstated, the Agency shall so notify the test facilityand all organizations and persons who were notified, as prescribed insection 28.Suspensionorterminationof a test facilityby a sponsorReinstatement of adisqualified testfacilitye. A determination that a test facility has been reinstated is disclosable to thepublic.32.a. A person who contravenes a provision of these regulations is guilty of anoffence and liable on conviction:-i. in the case of an individual, to imprisonment for a term notexceeding two years or to a fine not exceeding N50,000 or to bothimprisonment and fine.ii. In the case of body corporate, to a fine not exceeding N100,000.Penalty19

. Where an offence under these Regulations is committed by a bodycorporate or firm or other association of individuals:-i. every director, manager, secretary or other similar officer ofthe body corporate; orii.iii.iv.every partner or officer of the firm; orevery trustee of the body concerned; orevery person concerned in the management of the affairs of theassociation; orv. every person who was purporting to act in a capacity referredto in paragraphs (i) to (iv), is severally guilty of that offenceand liable to be proceeded against and punished for thatoffence in the same manner as if he had himself committed theoffence unless he proves that the act or omission constitutingthe offence took place without his knowledge, consent orconnivance. .33. In these regulations, unless the context otherwise requires the followingterms shall have the meanings specified:InterpretationFor the purpose of these Regulations, unless the context otherwise requires, thefollowing terms shall have the meanings specified:ActAgencyBatchExperimentalcompletion dateExperimentalstarting dateGood LaboratoryPractice (GLP)MarketingauthorisationThe NAFDAC act 1993 as amendedNational Agency for Food and Drug Administration and ControlA specific quantity or lot of a test or reference item produced during adefined cycle of manufacture in such a way that it could be expected tobe of a uniform character and shall be designated as such.The last date on which data are collected from the non-clinical study.The date on which the first study-specific data are collectedIs a quality system concerned with the organizational process and theconditions under which non-clinical health and environmental safetystudies are planned, performed, monitored, recorded, archived andreportedA legal document issued by the Agency that establishes the detailedcomposition and formulation of the product or its ingredients and of the20

(product license,registrationcertificate)Master scheduleNon-clinical studyPersonPrincipalinvestigatorQuality assuranceprogramRaw dataReference (control)itemRegulated productsRegulatory authorityfinal product itself and it includes details of packaging, labelling andshelf life according to defined specificationsA compilation of information to assist in the assessment of workloadand for the tracking of studies at a test facilityAn in-vivo or in-vitro experiment or set of experiments in which a testitem is examined under laboratory conditions or in the environment toobtain data on its properties and/or its safety, intended for submission toappropriate regulatory authorities in order to ensure health andenvironmental safety. The term does not include studies utilizing humansubjects or clinical studies or field trials in animals. The term does notinclude basic exploratory studies carried out to determine whether a testitem has any potential utility or to determine physical or chemicalcharacteristics of a test item.An individual, partnership, corporation, association, scientific oracademic establishment, government agency, or organizational unitthereof, and any other legal entity.An individual who for a multi-site study acts on behalf of the studydirector and has defined responsibilities for delegated phases of thestudy.ote: a study director’s responsibility for the overall conduct of thestudy cannot be delegated to the principal investigator(s); this includesapproval of the study plan and its amendments, approval of the finalreport, and ensuring that all applicable principles of Good LaboratoryPractice are followed. Replacement of the principal investigator shallbe done according to established procedures, and shall be documentedA defined system, including personnel, which is independent of studyconduct and is designed to ensure test facility management ofcompliance with the principles of Good Laboratory PracticeAll original test facility records, laboratory worksheets, anddocumentation such as memoranda, notes or verified copies thereof,which are the result of the original observations and activities in a study.Raw data also may include, for example, photographs, microfilm,microfiche copies, computer readable media, dictated observations,recorded data from automated instruments, or any other data storagemedium that has been recognised as capable of providing secure storageof information for a time period as prescribed in section 21.Any food additive, colour additive, drug, biological product, medicaldevice for human and animal use, or any item other than a test item,feed, or water that is administered to the test system in the course of anon-clinical laboratory study for the purpose of establishing a basis forcomparison with the test item.Food, drug, cosmetics, medical devices, packaged water, chemicals anddetergentsAny authority in any country or territory with legal responsibility for21

aspects of the control of chemicals or items of natural or biologicaloriginRegulatory hearing Includes any procedure adopted by the Agency which includes butlimited to consultative meetings, stakeholders forum etcShort term study A study of short duration with widely used routine techniquesSpecimenAny material derived from a test system for examination, analysis, orretention.Sponsor A person who initiates and supports, by provision of financial orother resources for a non-clinical laboratory study A person who submits a non-clinical study to the Agency in supportof an application for a marketing authorisation; or A test facility, if it both initiates and actually conducts the study.Standard operatingprocedures (SOPs)Study completiondateStudy DirectorStudy initiation dateStudy plan(protocol)Study planamendmentStudy plan deviationTest systemTest facilityTest facilitymanagementTest itemTest sitemanagement (ifappointed)The documented procedures which describe how to perform tests oractivities normally not specified in detail in study plans or testguidelinesThe date the Study Director signs the final reportAn individual responsible for the overall conduct of a non-clinicallaboratory study.The date the Study Director signs the study plan.A document which defines the objectives and experimental design forthe conduct of the study, and includes any amendments.An intended change to the study plan after the study initiation date.An unintended departure from the study plan after the study initiationdate.Any biological, chemical or physical system or a combination thereofused in a studyThe persons, premises, and operational unit(s) that are necessary forconducting a non-clinical health and environmental safety study. Formulti-site studies, those which are conducted at more than one site, thetest facility comprises the site at which the study director is located andall the individual test sites, which individually or collectively can beconsidered as test facilities.The person(s) who has the authority and formal responsibility for theorganisation and functioning of the test facility according to theprinciples of Good Laboratory Practice.Any food, packaged water, food and feed additive, colour additive,drug, biological product, cosmetics, medical device for human or animaluse, or any other item subject to regulation under the NAFDAC ActThe person(s) responsible for ensuring that the phase(s) of the study, forwhich he is responsible, are conducted according to the principles ofGood Laboratory Practice22

VehicleAny agent which serves as a carrier used to mix, disperse, or solubilisethe test item or reference item to facilitate the administration/applicationto the test system34. These Regulations may be cited as Good Laboratory Practice Regulations2008.CitationMADE AT ABUJA THIS……….DAY OF…………………………..2008.ChairmanGoverning CouncilNational Agency for Food andDrug Administration and Control(NAFDAC).Prof. Dora AkunyiliDirector-General,National Agency for Foodand Drug Administration andControl (NAFDAC)23