Contract Laboratory Procedures

Qualifications of personnel Services available Offered procedures Capability to complete project Quality controls program Quality assurance program Review and approve contracts Future compliance audits Database management Validation/verification needs Contract laboratories Procedures Facilities/equipment Personnel qualification Training Methodology... 

During remedial operations, large costs can be incurred if cleanup operations are delayed by slow response in the analysis of samples. Thus, analytical techniques must be available to verify that a cleanup criterion has been achieved and to indicate during cleanup efforts whether to stop or proceed. Preliminary discussions of proposed excavation approaches led to the requirement of 20 to 25 analyses within a 24-hour period. The standard EPA contract laboratory procedure required a minimum of 72 hours elapsed time including data reporting and data validation by EPA. Unfortunately, available protocols such as the EPA Contract Laboratory (CLP) mechanism, typically required two weeks or longer to produce verified data. Alternatives were needed to meet the unique demands of site remediation. 

The previously described contract laboratory procedure was modified to permit faster data turnaround. The major changes included the following ... 

The EPA publishes Series Methods that describe the exact procedures to be followed with respect to sample receipt and handling, analytical methods, data reporting, and document control. These guidelines must be followed closely to ensure accuracy, reproducibility, and reliability within and among the contract laboratories. 

If a separate confirmatory procedure is necessary, the analysis will be conducted in an FDA laboratory. The sponsor may have one or more of the contract laboratories test... 

Guidelines for acceptability of NADA and non-NADA methods are the same. For the determinative procedure, the criteria described in Method Criteria for accuracy and precision are used to evaluate data generated at participating laboratories. There are no criteria for accuracy in the analysis of the incurred residue samples however, the overall data set is reviewed to see if there is general agreement between results obtained by contract laboratories and relative to the levels reported in the sponsor s laboratory. 

The terminology used in this Standard is slightly different from the others in that it is appropriate for the particular discipline. For example, the term, referral laboratories in paragraph 4.5 of ISO 15189 is used in a slightly different sense to the comparable clause in ISO/IEC 17025. Included in this section are consultants who may provide a second opinion. If the referral laboratory is an external laboratory, to which samples are submitted for a supplementary or confirmatory examination procedure and report, it is much the same as a contract laboratory in ISO/IEC 17025. There is an extra Annex in this Standard which covers the ethics applicable to laboratory medicine. 

A price calculation is relatively easy for a product with a track record of a regular industrial-scale production. On the other hand, it is difficult, if only a laboratory procedure exists and a calculation has to be made based on the virtual scaleup to industrial-scale production. The ability to perform this desk exercise in a quick and reliable fashion is an important competence criterion of a fine-chemical manufacturer. When setting a price, a separation of tasks must be made between the controller, who calculates the manufacturing cost, and the sales manager, who determines the sales price. If mistakes have been made and prices have to be changed, you will need facts to support your request. If a pivotal product is supplied, a supply contract is concluded. 

Drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel. These requirements also apply to selection and control of subcontractors. Subcontractors include toll manufacturers and contract laboratories. 

Research support was provided by the U.S. Environmental Protection Agency under Contract No. 806256-02, J. Keith Carswell, Project Officer. We wish to thank M. E. Post for her advice and help in developing the laboratory procedures and B. Najar for significantly contributing to the laboratory analyses. 

Outsourcing the development, validation, and performance of analytical methods in recent years has become a popular means to facilitate movement of product through the development process. A recent industry survey reported that the vast majority (86%) of the companies responding say they outsource analytical methods development to contract laboratories. Twenty-five percent of the responding firms indicated that they often or always contract out stability testing on development compounds [37]. There are important criteria to follow in working with contract laboratories to ensure that their methods validation procedures yield results that are consistent with those of the client company [38]. This topic will be discussed later in this chapter. 

External audits of raw material suppliers and contracted services should be handled in much the same way as the internal QAP. Audit protocols should be customized and tailored to the specific organization to be audited. For example, an assessment of a contract laboratory service should be conducted under the auspices of the internal audit team and follow similar procedures in terms of identifying deficiencies, installing corrective and preventative measures, and reports issuing. It is an advantage to employ the same personnel for both the internal and external audits. This approach assures a standardized and uniform audit procedure across the board. 

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 onsite validation and revalidation. When contract laboratories are being used, verification that the laboratory is using the correct analytical methods and specifications should be performed. 

The Contract Laboratory Program procedure required delivery of specified documents included data summary forms, calibration data, chromatograms, and mass spectra and were generally shipped by air freight. Upon receipt by EPA, the documents were reviewed for data usability which was based on consideration of completeness of documentation and adherence to quality control requirements... 

Test methods—The analytical procedures used to test the finished API should be provided in the application. The level of detail is again subject to company philosophy however, sufficient detail should be included to provide the reviewer with a solid understanding of the method. In certain countries, the test methods may actually be run in an agency or contract laboratory, to confirm results on samples provided with the application. Certain tests can be performed using established compendial methods, with the compendial method referenced in the application. Often it is helpful to attach copies of these... 

This document describes the procedure for sampling experimental compounds to third-parties, such as customers, contract laboratories, and engineering firms in compliance with the TSCA exemption for research and development substances. 

Technology transfer generally begins during Phase III clinical studies. This includes both transfer of the manufacturing process of drug substance and product and of testing procedures to specific company facilities or contract laboratories for implementation as chemical and commercial product sources. 

Thomas, M.C., Noles, G.T. (1978). Sandia fossil fuel analytical laboratory procedures used in coal liquefaction analyses (Advanced Development Division, Sandia Laboratory, Albuquerque, NM). Washington, DC United States Department of Energy, April 1, 1978. Contract Number EY-76-C-04-0789. Available from NTIS, Springfield, VA SAND-78-0088. 

This procedure, Strike believes, was not tried by Eleusis. But his theory on the use of partial solubility is very old and founded. Taken, as we all are, by Eleusis unique genius, our beloved Bee TDK contracted a Philippine research laboratory to apply this proposal. Here is what they said ... 

All items of equipment must be considered, including balances and volumetric measuring devices, not just the expensive equipment. In terms of instrumentation, while a method using a mass spectrometer may be ideal for the study, if no such equipment is available the job will have to be contracted out to another laboratory, or another approach agreed with the customer. Neutron activation or radiochemical measurements require special equipment and dedicated laboratory facilities and safety procedures. Such techniques are often not generally available and are better left to specialist laboratories. 

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