Laboratory inspections

Each analytical laboratory inspected shipments as they were received, and documented the receipt of the samples and their condition. Any problems were immediately communicated to the appropriate field phase management study personnel to facilitate immediate corrections, such as re-shops required because the wrong commodity had been sampled. 

Tai Van Ha of the Nebraska State Agriculture Laboratory inspects a sample of fertilizer that is obviously not homogeneous. There are various light- and dark-colored granules of fertilizer in the bag. 

The 1989 OECD council decision Recommendation on Comphance with Good Laboratory Practice requires the establishment of national comphance monitoring program based on laboratory inspections and study audits and recommends the use of the guides for comphance monitoring procedures for good laboratory practice and the guidance for the conduct of laboratory inspections and study audits. 

Based on the verification process already defined, upon receipt of purchased material the laboratory inspects and verifies that the received materials conform to the purchase requirements. When the verification is made at the supplier s premises there is a need to make arrangements for such verification and for a definition of the method for the release of products. 

To reduce barriers to trade the Organisation for Economic Cooperation and Development worked on that topic and pnblished its first decision in 1981. To introduce an internationally accepted system in all countries the OECD pnblished Cuides for Compliance Monitoring Procednies for CLP and Cnidance for the Conduct of Laboratory Inspections and Stndy Audits in 1989 which ate binding for all OECD member states. 

It also comprises reporting and internal market (= mutual acceptance of data) requirements. The directive requires that the OECD Revised Guides for Comphance Monitoring Procedures for GLP and the OECD Guidance for the Conduct of Test Facility Inspections and Study Audits must be followed during laboratory inspections and study audits. 

Food and Drug Administration, Office of Planning and Evaluation. OPE Study 49 Results of the Toxicology Laboratory Inspection Program (Jan.-March 1979). July 1979. 

Table I. Commercial Thermal Reforming of Pennsylvania Gasoline Laboratory Inspections of Feed and Liquid Products...

The over-all material balance, prepared for the test period on the combined operation of the thermal reformer and the polymerization unit, appears in Table II. It is based on the streams actually fed and produced. Table III shows the debutanized reformate and debutanized polymer streams separately and as a combined stream. Laboratory inspections of the debutanized reformate and of the debutanized reformate plus polymer blend are presented in Table I. 

The Quality Assurance and Laboratory Inspection Section at DCLS consists of a staff of five, and is responsible for a number of functions in addition to its QA function. Staff members inspect and certify independent and municipal laboratories in Virginia that conduct analyses covered by EPA s Safe Drinking Water Act. In addition, the section is responsible for administering the safety program for the laboratory. Another function of the section is to evaluate a number of products for compliance with bid specifications in support of procurement activities for the Division of Purchases and Supply. Because of these... 

The conduct of a chemistry-related good laboratory practice (GLP) laboratory inspection and data audit will be discussed in this paper. This will be accomplished fcy describing the basic audit procedure, then digressing into the objectives of an audit and the primary problem areas that have been experienced. 

The laboratory to be inspected will receive a letter approximately two weeks before the Agency inspection team arrives that specifies which studies will be audited and if a laboratory GLP inspection is to be included. Upon arrival, the inspector will present official credentials and a Notice of Inspection form. The GLP portion of the audit is now conducted as if GLPs for all types of studies were in effect. For those laboratories conducting non-GLP studies, this is done to give an idea of what to expect when, and if, the GLP regulations become law. The laboratory inspection aspects will be reviewed briefly and then the data audit portion will be discussed. 

OECD. No. 3 Revised Guidance for the Conduct of Laboratory Inspections and Study Audit. http //www.olis.oecd.org/ohs/1995doc.nsf/LinkTo/ocde-gd(95)67... 

One should verify that the method of recordkeeping in the development laboratory follows what is stipulated in the FDA s Laboratory Inspection Guide, from June 1992. The system should also be evaluated for the transfer of validated analytical methods. On-site validation of the method is required for analytical methods validated at another laboratory. A written procedure should be available covering both the transfer of methods and on-site validation... 

In 1989, the OECD Council adopted an Act on Compliance with Principles of GLP. This Act contains a Decision that member countries shall (1) establish national procedures for monitoring compliance with GLP Principles, based on laboratory inspections and study audits (2) designate national compliance monitoring authorities ( CLP inspectors ) and (3) require the management of test facilities to issue a... 

Revised Guidance for the Conduct of Laboratory Inspections and Study Audits (1995). 

Commission on Laboratory Inspection and Accreditation. Reagent water Specifications. Skokie, IL College of American Pathologists, 1985. 

In 1981, the OECD Principles of GLP were finalized and led to the OECD Council Decision on the Mutual Acceptance of Data (MAD) which states that Data generated in the testing of chemicals in an OECD member country in accordance with OECD Test Guidelines and OECD principles of Good Laboratory Practice shall be accepted in other member countries for purposes of assessment and other uses relating to the protection of man and the environment . The OECD recommended in 1983 that implementation of GLP compliance should be verified by laboratory inspections and study audits. The EC later ratified the OECD principles and a number of Directives (e.g., 2004/9/EC, 2004/10/EC) indicates that tests must be carried out in compliance with the principles of GLP and that also that EU Member States must incorporate into their laws the requirement for all nonclinical safety studies to be conducted in compliance with GLP, and that premises conducting such studies must be inspected by a national authority. 

It may rightfully be said that all this information is interesting in terms of laboratories in the United States, but what about GLP inspections abroad What steps has the agency taken in this direction When the FDA developed the GLP regulations and its laboratory inspection program in 1976,... 

Laboratory inspection programs assure that the laboratory maintains up-to-date documentation, procedure manuals, qualified personnel, and properly maintained laboratory equipment. Successful laboratory inspections are required to maintain accreditation by the Joint Commission on Health Care Organizations and the HCFA. 

Hug, A. J., Laboratory Inspection of Wing Lower Surface Structure from 707 Aircraft for the J-STARS Program, The Boeing Co., FSCM81205, Document D500-12947-1, Wichita, KS, April 1994 (1996). 

In 1848, however, the first U.S. drug law, the Drug Importation Act, was enacted when American troops serving in Mexico became seriously ill from the quinine that was administered to treat malaria. The quinine was subsequently discovered to be adulterated. This law required laboratory inspection, detention, and even... 

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