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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Articles

Comparison of FDA, EPA, OECD GLP          Article
Topic FDA EPA OECD
Article
Characterization
58.105
(a) The identity, strength, purity, and composition or other characteristics which will appropriately define the test or control article shall be determined for each batch and shall be documented. Methods of synthesis, fabrication, or derivation of the test and control articles shall be documented by the sponsor or the testing facility. In those cases where marketed products are used as control articles, such products will be characterized by their labeling.
792.105
(a) The identity, strength, purity, and composition, or other characteristics which will appropriately define the test, control, or reference substance shall be determined for each batch and shall be documented before its use in a study. Methods of synthesis, fabrication, or derivation of the test, control, or reference substance shall be documented by the sponsor or the testing facility, and such location of documentation shall be specified.
Section II
6.2.1. Each test and reference item should be appropriately identified (e.g., code, Chemical Abstracts Service Registry Number [CAS number], name, biological parameters).
6.2.2. For each study, the identity, including batch number, purity, composition, concentrations, or other characteristics to appropriately define each batch of the test or reference items should be known.
6.2.3. In cases where the test item is supplied by the sponsor, there should be a mechanism, developed in cooperation between the sponsor and the test facility, to verify the identity of the test item subject to the study.
Article Stability 58.105
  1. The stability of each test or control article shall be determined by the testing facility or by the sponsor either:
    1. Before study initiation, or
    2. concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch.
792.105
(b) The stability of the test, control or reference substance shall be determined before the experimental start date or concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch.
Section II
6.2.4. The stability of test and reference items under storage and test conditions should be known for all studies.
Solubility of
Articles
  792.105
(b) When relevant to the conduct of the study the solubility of each test, control, or reference substance shall be determined by the testing facility or the sponsor before the experimental start date.
.
Labeling &
Storage
Containers for
Articles
58.105
(c) Each storage container for a test or control article shall be labeled by name, chemical abstract number or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test or control article. Storage containers shall be assigned to a particular test article for the duration of the study.
792.105
(c) Each storage container for a test, control, or reference substance shall be labeled by name, chemical abstracts service number (CAS) or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test, control, or reference substance. Storage containers shall be assigned to a particular test substance for the duration of the study.
Section Ii
6.1.3. Storage container(s) should carry identification information, expiry date, and specific storage instructions.
Reserve
Samples of
Articles
58.105 (d)
For studies of more than 4 weeks' duration, reserve samples from each batch of test and control articles shall be retained for the period of time provided by Sec. 58.195.
792.105
(d) For studies of more than 4 weeks experimental duration, reserve samples from each batch of test, control, and reference substances shall be retained for the period of time provided by Sec. 792.195..
Section Ii
6.2.6. A sample for analytical purposes from each batch of test item should be retained for all studies except short-term studies.
Stability of
Articles Under
Storage
Conditions
  792.105
(e) The stability of test, control, and reference substances under storage conditions at the test site shall be known for all studies.
Section II
6.2.4. The stability of test and reference items under storage and test conditions should be known for all studies.
Article
handling
58.107
Procedures shall be established for a system for the handling of the test and control articles to ensure that:
  1. There is proper storage.
  2. Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.
  3. Proper identification is maintained throughout the distribution process.
  4. The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.
792.107
Procedures shall be established for a system for the handling of the test, control, and reference substances to ensure that:
  1. There is proper storage.
  2. Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.
  3. Proper identification is maintained throughout the
    distribution process.
  4. The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.
Section II
6.1.1. Records including test item and reference item characterisation, date of receipt, expiry date, quantities received and used in studies should be maintained.
6.1.2. Handling, sampling, and storage procedures should be identified in order that the homogeneity and stability are assured to the degree possible and contamination or mix-up are precluded.
Uniformity of
Mixtures of
Articles with
Carriers
58.113
  1. For each test or control article that is mixed with a carrier, tests by appropriate analytical methods shall be conducted:
    1. To determine the uniformity of the mixture and to determine, periodically, the concentration of the test or control article in the mixture.
792.113
  1. For each test, control, or reference substance that is mixed with a carrier, tests by appropriate analytical methods shall be conducted:
    1. To determine the uniformity of the mixture and to determine, periodically, the concentration of the test, control, or reference substance in the mixture..
Section II
6.2.5. If the test item is administered or applied in a vehicle, the homogeneity, concentration and stability of the test item in that vehicle should be determined. For
test items used in field studies (e.g., tank mixes), these may be determined through separate laboratory experiments.
Stability of
Mixtures of
Articles with
Carriers
58.113
  1. For each test or control article that is mixed with a carrier, tests by appropriate analytical methods shall be conducted:
    1. To determine the stability of the test and control articles in the mixture as required by the conditions of the study either:
      1. Before study initiation, or
      2. Concomitantly according to written standard operating procedures which provide for periodic analysis of the test and control articles in the mixture.
792.113
  1. For each test, control, or reference substance that is mixed with a carrier, tests by appropriate analytical methods shall be conducted:
    1. To determine the stability of the test, control or reference substance in the mixture before the experimental start date or concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch.
Section II
6.2.5. If the test item is administered or applied in a vehicle, the homogeneity, concentration and stability of the test item in that vehicle should be determined. For
test items used in field studies (e.g., tank mixes), these may be determined through separate laboratory experiments.
Solubility of
Articles in a
Mixture
  792.113
  1. For each test, control, or reference substance that is mixed with a carrier, tests by appropriate analytical methods shall be conducted:
    1. When relevant to the conduct of the experiment, to determine the solubility of each test, control, or reference substance in the mixture by the testing facility or the sponsor before the experimental start date.
 
Expiration of
Article Mixtures
58.113
(c) Where any of the components of the test or control article carrier mixture has an expiration date, that date shall be clearly shown on the container. If more than one component has an expiration date, the earliest
date shall be shown
792.113
(b) Where any of the components of the test, control, or reference substance carrier mixture has an expiration date, that date shall be clearly shown on the container. If more than one component has an expiration date, the earliest date shall be shown.
 
Interference of
Vehicle with
Article
  792.113
(c) If a vehicle is used to facilitate the mixing of a test substance with a carrier, assurance shall be provided that the vehicle does not interfere with the integrity of the test.
 
Physical /
Chemical
Characterization
Studies
 

792.135

  1. All provisions of the GLPs shall apply to physical and chemical characterization studies designed to determine stability, solubility, octanol water partition coefficient, volatility, and persistence (such as biodegradation, photodegradation, and chemical degradation studies).
  2. The following GLP standards shall not apply to studies designed to determine physical and chemical characteristics of a test, control, or reference substance:
    Section 792.31 (c), (d), and (g)
    Section 792.35 (b) and (c)
    Section 792.43
    Section 792.45
    Section 792.47
    Section 792.49
    Section 792.81(b) (1), (2), (6) through (9), and (12)
    Section 792.90
    Section 792.105 (a) through (d)
    Section 792.113
    Section 792.120(a) (5) through (12), and (15)
    Section 792.185(a) (5) through (8), (10), (12), and (14)
    Section 792.195 (c) and (d)
    Subparts H-I [Reserved]
Section II
5.1.1. Apparatus used for the generation of
physical/chemical data should be suitably located and of appropriate design and adequate capacity.
5.1.2. The integrity of the physical/chemical test systems should be ensured.