Test and control articles

Subpart F - Test and Control Articles Sec. 58.105 Test and control article characterization. 

Sec. 58.107 Test and control article handling. Sec. 58.113 Mixtures of articles with carriers. 

Facilities for handling test and control articles Laboratory operation areas Specimen and data storage facilities Equipment design... 

A facility that conducts both GLP-regulated and non-GLP-regulated studies should think carefully about attempting to maintain a dual standard in any one laboratory or with any one group of laboratory workers. In the author s experience, such a dual standard is very difficult to maintain without carryover of non-GLP standards to GLP-regulated work. In such a case it may be far better to maintain a general GLP standard (e.g., data collection, record keeping) for all work in the laboratory, but perhaps allow exceptions for the non-GLP studies in areas such as quality assurance (QA) inspections and analytical requirements for test and control articles and article/carrier mixtures. 

The potential for spreading disease organisms from animals to humans and vice versa is not obvious to most people. These so-called zoonotic diseases include agents of all the major categories of infectious organisms viruses, bacteria, parasites, and fungi. Infectious hazards are insidious, and therefore safe practices should be habitual and strictly enforced. All employees should be instructed as to the nature of these hazards and the means to take to protect animals and themselves from infection. Employees should also be instructed to report all personal illnesses to their supervisor. The supervisor can then determine whether or not it would be appropriate for the employee to have contact with test and control articles and test systems. 

Mixing of the test and control articles with a carrier, e.g., feed. 

Dedicated areas are usually provided for the receipt and storage of test and control articles. Such articles are usually stored under lock and key. Areas for weighing test and control articles are often equipped with special air-handling systems, sometimes roomwide and other times hmited to the area immediately surrounding the weighing devices. Many laboratories have a policy for weighing only one test or control article at any one time in any one area. 

If it is necessary to store test and control article mixtures, such materials should be stored entirely separately from animal housing areas. Special storage conditions (e.g., refrigeration and protection from light) must be available if needed to preserve and maintain the quality and stability of the mixtures. 

The use of standard solutions, reference standards, and quality control samples, whether prepared by the laboratory or purchased commercially, is essential to valid analyses of test and control article/carrier mixtures and biological fluids (blood, serum, plasma, etc). 

SUBPART F TEST AND CONTROL ARTICLE 58.105 Test and Control Article Characterization... 

Tests to establish the identity, strength, and purity of the test and control articles need not comply strictly with GLP requirements (e.g., protocol, QAU inspection requirements), but good documentation of anal5dical test results (usually in a laboratory notebook) and retention of raw data for such tests is a good practice. As the development process proceeds and the same material is used in both nonclinical and clinical studies, CGMP principles wiU apply to the production and characterization processes. 

The general goals of 58.107 are to maintain the integrity of and to provide accountability for the test and control articles throughout the period of use. 

The accountability provisions of 58.107(d) are met by records showing the date and quantity of test and control articles distributed from central stores for use in a study or series of studies and the date and amount of material returned to central stores at the end of a study or amount of material returned to central stores at the end of a study or series of studies. To this should be added a system for documenting the date and quantity for each use of a test or control article during the course of each study. A running inventory of test and control articles is not required but does provide an easy... 

To determine the stability of the test and control articles in the mixture as required by the conditions of the study either (i) before study initiation, or (ii) concomitantly according to written standard operating procedures which provide for periodic analysis of the test and control articles in the mixture. 

The requirements of 58.113(a) substantially changed the state of the art for the conduct of nonchnical laboratory studies. Prior to the promulgation of GLP regulations, anal5di-cal tests to estabhsh the homogeneity and stabihty of article/ carrier mixtures were not routine, nor were tests to determine the concentration of test and control articles in the mixtures used to dehver test and control articles to test systems. 

Identification of the test and control articles by name, chemical abstract number, or code number. The name of the sponsor and the name and address of the testing facihty at which the study is being conducted. 

The test and control articles identified by name, chemical abstracts number or code number, strength, purity, and composition or other appropriate characteristics. 

Any significant changes in test and control article handling from those currently reported are examined. 

The FDA investigators have the authority to collect samples as described under the comphance program 7348.808. Samples of a test article, the carrier, the control article or test and control article mixtures may be selected and sent to FDA laboratories to determine the identity, strength, potency, purity, composition, or other characteristics that wiU accurately define the coUected sample. In fact, even physical samples such as wet tissues, tissue blocks, and slides may be collected. When the field investigator collects a sample of any chemical substance, he will also coUect a copy of the methodology from the sponsor of the testing facihty. The copy of the methodology will be sent to the FDA laboratory selected to perform the sample analysis. 

Receipt, storage and handling of test and control article... 

Test and control article receipt/storage/archival/distribution... 

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