Test methods and standards

Keywords biodegradation behavior, biodegradation standard, composting, abiotic degradation, biotic degradation, anoxic degradation, aerobic degradation 

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TheMmerican Standards and Testing Methods Manual, The American Society for Testing and Materials, Philadelphia, Pa., 1992. 

Standards and Test Methods of the Air Movement and Gontrol Association International, Inc., 30 West University Drive Arlington Heights, Illinois 60004-1893 USA FAX 847-253-0088 Phone 847-394-0150. 

Z. T. Chowhan, Progress and impediments in the harmonization of excipient standards and test methods,... 

The pilot-production program is generally a result of cooperation between the development laboratories and the manufacturing department. Technology transfer documentation applies to processes as well as to the systems being qualified and validated and their testing standards and testing methods. This documentation is important, particularly where an NDA is involved. 

Other textile products that require composite flammability testing are protective clothing assemblies for fire fighters suits, military flight suits, etc. Flammability standards and test methods for textile components in protective clothing have been discussed by Bajaj21 and Horrocks.22... 

In this manner, key objectives of harmonization will be attained only when the PDG is able to achieve mutually agreeable standards and test methods, which provide the same conclusions when performed on the same specimens, even if they use different specifications, procedures, or reagents. We should continue to take necessary steps to deepen international cooperation and to obtain harmonized compendial standards and methodology, using the PDG as the forum for harmonization of drug quality. 

Stability test guidelines for new active ingredients implemented. Standards and test method guidelines enforced. 

Details on ingredients, manufacturing methods emd standards and test methods should be described in a separate paper attached to the application form. 

For the application of a partial change including change of manufacturing method, directions and dose, indications and effects, cmd the storage and expiration date or standards and test method, another form on which items for approval number and approval date are added to the application form should be submitted. 

For a change in formulation such as excipients, measured values (except when there are no effects on the standards and test methods), stability test (in cases that the stability after the change is not worse than before, a relative comparative test) and bioequivalence tests are required. 

Data on Physicochemical Properties, Standards and Test Methods (Data b. 1-3 in Table 3)... 

For the approval of a drug, it is necessary to know the results of elementary analysis, the structural formula, ultraviolet cind infrared absorption. X-ray diffraction and the other physicochemical properties of the substance. The test results on the forced decomposition, decomposition mechanism, etc., of bulk drugs are to be part of b-2 (Notification No. 43 of the PAB in 1992). The contents of the standards and test methods in the application form for new drugs should follow the guidelines on the standards and test methods for new drugs (Notification No. 586 of the PAB in 1994). 

Table 7. Items to be clarified in the standards and test methods.

In the case that each applicant applies for approval of a new drug with the same ingredients and same cimount, same dosage forms and same test methods, the data on standards and test methods can be prepared by one member and another member may preserve a copy. The data of measured values from the test results to confirm that the drug meets the standards established by the test methods should be submitted by each applicant. 

In the case that photographs of TLC in the data of standards and test methods or tissues in the data of toxicity, etc., are unclear, it is required to submit those photographs separately. 

The United States Pharmacopeia works closely in conjunction with the Food and Drug Administration (FDA), the pharmaceutical industry, and health professionals in establishing their standards, which are enforceable by the FDA and the governments of more than 35 countries. Failure to comply with USP-National Formulary (NF) standards and test methods can result in products that are adulterated, leading to a variety of negative outcomes including FDA recalls and warning letters. 

Generally, chemical warehouses whose contents classify them as hazardous occupancies should be constructed of fire resistive or noncombustible construction. Fire resistive construction should consist of materials that will withstand the anticipated fire exposure of a given duration without structural failure. The following standards and test methods are commonly used to establish selected fire resistance ratings ... 

While the GMPs represent how to guides for the manufacture, processing, holding, and testing of medicinal products, they are not the same as Pharmacopoeias. A Pharmacopoeia provides specifications, standards, and test methods for the products (raw materials and finished products) that the pharmacopoeia covers. GMPs and pharmacopoeias work in tandem. 

Pharmacopoeias are texts providing specifications, standards, and test methods used in evaluating the purity and quality of both raw materials and finished pharmaceutical products. To claim a product is of pharmacopoea grade requires that the product be tested by a pharmacopoeial test method, or by a methods proven to be equivalent, and that the tested material meets the pharmacopoeial requirements in all its specifications. 

Alliance for the Polyurethanes Industry -Building Codes, Standards, and Test Methods... 

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