Samples and Tests

A laboratory information management system (LIMS) is a computer or computer network used to automate the acquisition and management of raw analytical data. In its simplest form, it tracks samples and test results through analytical laboratories and provides summaries of the status of these samples and tests. In its most advanced form, the system is interfaced to the laboratory s instmmentation and communication network to allow automation of data gathering, compilation, and reporting. 

ASTM D5147, Standard Test Methods for Sampling and Testing Modified Bitumen Sheet Materials, ASTM, Philadelphia, Pa. 

Current Good Manufacturing Practice for Finished Pharmaceuticals, Sampling and Testing of In-Process Materials and Drug Products, (1998), CFR, Title 21, Part 211, Volume 4, Section 211.110. 

Sec. 211.110 Sampling and testing of in-process materials and drug products. 

Degree of Precision Required. A statement of the required precision of the results from the sampling effort for each characteristic of Interest is needed to allocate sampling and testing resources efficiently. As previously discussed, the form of these statements will depend on the objective and type of characteristics. The users of the study results must make these determinations. Statistical methods to evaluate tradeoffs and alternatives may be useful in assisting the study administrators in this effort. 

Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. Such samples shall be representative and properly identified. 

Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed. 

ASTM D 268-96, Guide for Sampling and Testing Volatile Solvents and Chemical Intermediates for Use in Paint and Related Coatings and Materials, Annual Book of ASTM Standards, ASTM, West Conshohocken, PA (1998), Vol. 06.04. 

The section on components deals with all materials that may be used in the manufacture, processing, and packaging of drug products, plus materials used for maintenance of the building and equipment. They must be stored and handled in a safe, sanitary, and orderly manner. These precautions are needed to prevent mix-ups and cross-contamination of drugs and drug products. All items should be held until they have been sampled and tested according to the company s specifications and not released until the tests have been completed. In this section it is required that ... 

The master records should also indicate the sampling and test procedures involved with in-process control and sampling procedures for finished drug products... 

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