Industry documents: test standards

The national organizations are often relayed into each profession by a body created and financed by this profession and which undertakes all or part of the work in preparing the standards. In the petroleum industry, this role is carried out in France by the BNPet (Bureau de Normalisation du Petrole) and in Germany by the FAM (Fachausschuss Mineralol-und Brennstoffnormung), in the United Kingdom by the IP (Institute of Petroleum), and in the USA by the ASTM (American Society for Testing and Materials). In the first two cases, the standards are published only by the national organizations (AFNOR and DIN respectively), while the IP and the ASTM also publish their own documents, only some of which are adopted by the BSI and ANSI, respectively. 

Approved techniques for manual and mechanical sampling are often documented for various commodities handled in commerce by industiy groups. Examples are the International Standards Organization (ISO), British Standards Association (BSA), Japan Institute of Standards (JIS), American Society for Testing Materi s (ASTM), and the Fertihzer Institute. Sampling standards developed for use in specified industry applications frequently include instructions for labora-toiy work in sample preparation and analysis—steps (2) and (3) above. 

Since the publication of the first edition of this book, a few more validated methods for the analysis of soft drinks ingredients have been documented. When the first edition was published in 1998, only a handful of methods for the analysis of soft drinks ingredients had been collaboratively tested in the Association of Official Analytical Chemists (AOAC) official methods manual, and only two of these were modern HPLC approaches. At that time, no methods could be found in the British Standards catalogue. Inspection of the British Standards website (http //www.bsi-global.com) now shows that there are two standardised approaches for the analysis of high-intensity sweeteners in soft drinks, both of which use HPLC. This overall lack of standardisation of methods is probably because a soft drink s matrix is relatively straightforward, without many of the problems associated with other areas of food analysis, and so the industry has not felt the need to standardise the test methods. 

Tests should be conducted on the final packaged product. The protocol applied should be one that leads to minimal interruption of the standard manufacturing operations of the facility. Intermediate pilot plant studies should be carried out to simulate large-scale industrial sterilization cycles. The EtO cycle documentation should be integrated into a single protocol. An example of one protocol is as follows ... 

These inspections can be either informal or formal. The informal approach is to have a complete in-depth review of the entire process with a written report. The formal approach is to have a mock FDA inspection, which is extremely useful in identifying system and process failures at all levels. The latter offers practice in both preparing for and interacting with an FDA investigator as well as testing the breadth and depth of documentation that would be needed for the FDA inspection process. In all cases, the use of a third-party experts allows for a more objective evaluation of the entire process from a fresh pair of eyes and from someone who can offer an objective comparison against current industry standards. 

Results of RIPT, modified Draize test, and human maximization tests have been accepted as valid by regulatory agencies however, some sponsors routinely use one of the methods described and defend its use as the standard of the industry . FDA reviewed details of sensitization procedures and developed a guidance document (1999) for evaluating skin sensitization to chemicals in natural rubber products. 

Variability in the Amount of Carbon in Reservoirs. In addition to variations in the production and distribution of radiocarbon over time and within portions of various carbon reservoirs, variations may result in situations where carbon not in equilibrium with the contemporary standard values is added or removed from any reservoir. Two instances of this are well documented since they occurred within the last century as a result of human intervention. The first is known as the industrial or Suess effect and is caused by the combustion of fossil fuels beginning about 1890, resulting in a depletion of atmospheric activities by about 3% (76). A more recent occurrence has been called the atomic bomb or Libby effect. The detonation of nuclear devices in the atmosphere beginning in 1945 produced large amounts of artificial increasing the radiocarbon concentrations in the atmosphere by more than 100% in the Northern Hemisphere (77). Because of equilibration with the oceans, the levels have been diminishing steadily since the atmospheric testing was terminated by the major nuclear powers except France and the People s Repub-... 

Howard Garston-Smith, formerly of Pfizer, has published a book on software quality assurance. It provides a postal audit checklist reproduced in Appendix 7C. If the supplier has already prepared an internal ISO 9000 mapping or an internal audit report on how it aligns to industry standards such as the GAMP Guide, this can be offered as an alternative to the auditor s postal checklist. A reduced postal checklist may be agreed upon, at the very least. Wherever possible, photocopies of actual example documents and test records should be inspected for documentary evidence of validation. Remember that the pharmaceutical and healthcare companies are themselves being inspected for documentary evidence of validation. 

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