Fda - Glp Studies, Non-Clinical

Front 1

Study director

Back 1

has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control.

Front 2

The study director shall assure that:

Back 2

(a) The protocol, including any change, is approved as provided by 58.120 and is followed.

(b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.

(c) Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.

(d) Test systems are as specified in the protocol.

(e) All applicable good laboratory practice regulations are followed.

(f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.

Front 3

Quality assurance unit

Back 3

responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study.

Front 4

Animal care facilities

Back 4

(a) A testing facility shall have a sufficient number of animal rooms or areas, as needed, to assure proper: (1) Separation of species or test systems, (2) isolation of individual projects, (3) quarantine of animals, and (4) routine or specialized housing of animals.

(b) A testing facility shall have a number of animal rooms or areas separate from those described in paragraph (a) of this section to ensure isolation of studies being done with test systems or test and control articles known to be biohazardous, including volatile substances, aerosols, radioactive materials, and infectious agents.

(c) Separate areas shall be provided, as appropriate, for the diagnosis, treatment, and control of laboratory animal diseases. These areas shall provide effective isolation for the housing of animals either known or suspected of being diseased, or of being carriers of disease, from other animals.

(d) When animals are housed, facilities shall exist for the collection and disposal of all animal waste and refuse or for safe sanitary storage of waste before removal from the testing facility. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, disease hazards, and environmental contamination.

Front 5

Animal care - health status

Back 5

All newly received animals from outside sources shall be isolated and their health status shall be evaluated in accordance with acceptable veterinary medical practice.

Front 6

Animal care - diagnosis, treatment of disease

Back 6

If, during the course of the study, the animals contract such a disease or condition, the diseased animals shall be isolated, if necessary. These animals may be treated for disease or signs of disease provided that such treatment does not interfere with the study. The diagnosis, authorizations of treatment, description of treatment, and each date of treatment shall be documented and shall be retained.

Front 7

Animal care - identification

Back 7

Warm-blooded animals, excluding suckling rodents, used in laboratory procedures that require manipulations and observations over an extended period of time or in studies that require the animals to be removed from and returned to their home cages for any reason (e.g., cage cleaning, treatment, etc.), shall receive appropriate identification. All information needed to specifically identify each animal within an animal-housing unit shall appear on the outside of that unit.

Front 8

Housing of different species

Back 8

Animals of different species shall be housed in separate rooms when necessary. Animals of the same species, but used in different studies, should not ordinarily be housed in the same room when inadvertent exposure to control or test articles or animal mixup could affect the outcome of either study. If such mixed housing is necessary, adequate differentiation by space and identification shall be made.

Front 9

Sanitization - animal cages, etc.

Back 9

Animal cages, racks and accessory equipment shall be cleaned and sanitized at appropriate intervals.

Front 10

Animals - Food and water

Back 10

Feed and water used for the animals shall be analyzed periodically to ensure that contaminants known to be capable of interfering with the study and reasonably expected to be present in such feed or water are not present at levels above those specified in the protocol. Documentation of such analyses shall be maintained as raw data.

Front 11

Animals - bedding

Back 11

Bedding used in animal cages or pens shall not interfere with the purpose or conduct of the study and shall be changed as often as necessary to keep the animals dry and clean.

Front 12

Animals - pest control

Back 12

If any pest control materials are used, the use shall be documented. Cleaning and pest control materials that interfere with the study shall not be used.

Front 13

Protocol

Back 13

(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following information:

(1) A descriptive title and statement of the purpose of the study.

(2) Identification of the test and control articles by name, chemical abstract number, or code number.

(3) The name of the sponsor and the name and address of the testing facility at which the study is being conducted.

(4) The number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system.

(5) The procedure for identification of the test system.

(6) A description of the experimental design, including the methods for the control of bias.

(7) A description and/or identification of the diet used in the study as well as solvents, emulsifiers, and/or other materials used to solubilize or suspend the test or control articles before mixing with the carrier. The description shall include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications.

(8) Each dosage level, expressed in milligrams per kilogram of body weight or other appropriate units, of the test or control article to be administered and the method and frequency of administration.

(9) The type and frequency of tests, analyses, and measurements to be made.

(10) The records to be maintained.

(11) The date of approval of the protocol by the sponsor and the dated signature of the study director.

(12) A statement of the proposed statistical methods to be used.

(b) All changes in or revisions of an approved protocol and the reasons therefore shall be documented, signed by the study director, dated, and maintained with the protocol.

Front 14

For each nonclinical laboratory study, testing facility management
shall:

Back 14

(a) Designate a study director as described in Sec. 58.33, before
the study is initiated.
(b) Replace the study director promptly if it becomes necessary to
do so during the conduct of a study.
(c) Assure that there is a quality assurance unit as described in
Sec. 58.35.
(d) Assure that test and control articles or mixtures have been
appropriately tested for identity, strength, purity, stability, and
uniformity, as applicable.
(e) Assure that personnel, resources, facilities, equipment,
materials, and methodologies are available as scheduled.
(f) Assure that personnel clearly understand the functions they are
to perform.
(g) Assure that any deviations from these regulations reported by
the quality assurance unit are communicated to the study director and
corrective actions are taken and documented.

Front 15

Standard operating procedures shall be established for, but not limited to, the following:

Back 15

Standard operating procedures shall be established for, but not
limited to, the following:
(1) Animal room preparation.
(2) Animal care.
(3) Receipt, identification, storage, handling, mixing, and method
of sampling of the test and control articles.
(4) Test system observations.
(5) Laboratory tests.
(6) Handling of animals found moribund or dead during study.
(7) Necropsy of animals or postmortem examination of animals.
(8) Collection and identification of specimens.
(9) Histopathology.

[[Page 310]]

(10) Data handling, storage, and retrieval.
(11) Maintenance and calibration of equipment.
(12) Transfer, proper placement, and identification of animals.