Components of laboratory accreditation.

Accreditation or certification is a recognition given to an operation or product that has been evaluated against a standard; be it regulatory or voluntary. The purpose of accreditation is to provide the consumer with a level of confidence in the quality of operation (process) and the product of an organization. Environmental Protection Agency/OCM has proposed the development of an accreditation program under National Environmental Laboratory Accreditation Program for Good Laboratory Practice (GLP) laboratories as a supplement to the current program. This proposal was the result of the Inspector General Office reports that identified weaknesses in the current operation. Several accreditation programs can be evaluated and common components identified when proposing a structure for accrediting a GLP system. An understanding of these components is useful in building that structure. Internationally accepted accreditation programs provide a template for building a U.S. GLP accreditation program. This presentation will discuss the traditional structure of accreditation as presented in the Organization of Economic Cooperative Development/GLP program, ISO-9000 Accreditation and ISO/IEC Guide 25 Standard, and the Canadian Association for Environmental Analytical Laboratories, which has a biological component. Most accreditation programs are managed by a recognized third party, either privately or with government oversight. Common components often include a formal review of required credentials to evaluate organizational structure, a site visit to evaluate the facility, and a performance evaluation to assess technical competence. Laboratory performance is measured against written standards and scored. A formal report is then sent to the laboratory indicating accreditation status. Usually, there is a scheduled reevaluation built into the program. Fee structures vary considerably and will need to be examined closely when building a GLP program.

Harmonization of good laboratory practice requirements and laboratory accreditation programs.

Efforts to harmonize Good Laboratory Practice (GLP) requirements have been underway through the Organization for Economic Cooperation and Development (OECD) since 1981. In 1985, a GLP panel was established to facilitate the practical implementation of the OECD/GLP program. Through the OECD/GLP program, Memoranda of Understanding (MOU) agreements which foster requirements for reciprocal data and study acceptance and unified GLP standards have been developed among member countries. Three OECD Consensus Workshops and three inspectors training workshops have been held. In concert with these efforts, several OECD countries have developed GLP accreditation programs, managed by local health and environmental ministries. In addition, Canada and the United States are investigating Laboratory Accreditation programs for environmental monitoring assessment and GLP-regulated studies. In the European Community (EC), the need for quality standards specifying requirements for production and international trade has promoted International Standards Organization (ISO) certification for certain products. ISO-9000 standards identify requirements for certification of quality systems. These certification programs may affect the trade and market of laboratories conducting GLP studies. Two goals identified by these efforts are common to both programs: first, harmonization and recognition of requirements, and second, confidence in the rigor of program components used to assess the integrity of data produced and study activities. This confidence can be promoted, in part, through laboratory inspection and screening processes. However, the question remains, will data produced by sanctioned laboratories be mutually accepted on an international basis?(ABSTRACT TRUNCATED AT 250 WORDS)

Physical and immunochemical characterization of proteoglycans synthesized during chondrogenesis in the chick embryo.

Chick limb buds from 4- to 7-day-old embryos and sterna from 14-day-old embryos were labeled with [35S]sulfate, and the sulfated proteoglycans (PGS) were extracted either with associative (0.5 M guanidine . HCl) or dissociative (4.0 M guanidine . HCl) solvents. The existence of several populations of PGS is revealed in each age group when the limb extracts are analyzed on sucrose density gradients under dissociative conditions. The major component of 7-day limbs has a faster sedimentation rate than does that of 4-day limb buds. These major components of 4- and 7-day extracts chromatograph in the void volume of a controlled-pore glass (CPG) 1400 column. They differ from each other immunologically. The CPG 1400 void volume material from 4-day limb mesenchyme (PGS(LM)-I) shows no cross-reactivity with antiserum against PGS from juvenile cartilage (A1-D1-1400 V0). In contrast, the CPG 1400 void volume material from 7-day limbs, which contain cartilage [PGS(LC)-I], gave a cross-reaction of 70%. When PGS(LM)-I is chromatographed on CPG 2500, 45% of the labeled material chromatographs in the void volume. When PGS(LM)-I is sedimented in a cesium chloride gradient under dissociative conditions, it can be shown that the PGS in the bottom fraction (D1) has a monomer-aggregate relationship. In the absence of hyaluronic acid, this fraction is included on CPG 2500, whereas in the presence of hyaluronic acid it is excluded. Limb mesenchyme, therefore, synthesizes a PGS molecule which can interact with hyaluronic acid to form an aggregate. The endogenous material of a 4-day limb mesenchyme which causes the aggregation of PGS cannot be separated from PGS by chromatography on CPG 240 or 1400 under dissociative conditions. In contrast, the aggregating material from sterna can be separated from PGS under these conditions. These observations are interpreted to mean that the aggregating material of limb mesenchyme is larger than is that of cartilage.