Laboratories, compliance requirements

Good Laboratory Practice 58.105(a) requires that all test articles be appropriately characterized. Compliance requires documentation that characterization has been done. The tests conducted to provide this documentation, however, are not GLP-regulated, although such tests wiU in many instances be subject to CGMP standards (e.g., when the test article will also be used in human clinical studies). 

The rationale for bringing a new instrument into the laboratories should be well founded. The benefits of acquiring the instrument, such as increasing productivity, meeting a specific need or regulatory compliance requirements, or enhancing the capability of the laboratories, should justify the expenditure of valuable resources required to bring the instrument in house and to support its operation. 

Most laboratory systems require maintenance and inclusion preventative maintenance programmes. Therefore any holistic testing should form part of Performance Qualification to ensure on-going compliance. 

The chemist reviews analytical results as they are received from the laboratory. It is particularly important for remediation projects with field decisions pending results of analysis. Laboratory data often guide remedial activities, such as soil removal, treatment plant operations, and compliance monitoring. For these projects, reliable data with expedited turnaround time of analysis may be necessary. To avoid making decisions on data of completely unknown quality, the chemist reviews such data in a cursory manner to verify that the basic laboratory QC requirements have been met, whereas a complete evaluation of data packages will be conducted later. 

Of the ISO series it is ISO 9001 that applies to the management of a laboratory. This requires that procedures be in place for all activities carried out within the workplace, that these procedures are recorded and that staff carries out the activities described in these procedures. Monitoring is required to ensure compliance and to modify and improve the procedures in the light of experience. The ISO 9001 Flowchart of the areas to be covered and supporting activities are shown in Figure B14. Laboratory management is directly responsible for the following ... 

Method validation is a process by which documented evidence is prepared and provided to show that the method meets the intended need. Highly regulated pharmaceutical analytical laboratories perform method validation and generate data on the following parameters, to comply with the compliance requirements of government agencies such FDA, EPA and/or to provide data for compendial agencies like USP, BP, etc. 

Customer Evaluation Testing. Customer evaluation testing allows the testing and receiving laboratories (the expected customers) to check whether a method performs adequately for its intended purpose. This evaluation should consider the specific country s compliance requirements with respect to the analytical methods. The customer evaluation permits direct customer feedback to the development lab prior to validation studies. 

More detailed information on the compliance requirements for the competence of calibration and testing laboratories is contained in ISO Guide 25. This guide has been interpreted to meet national requirements in some countries for example the UK Accreditation Service refers to it as UKAS MIO. Many laboratories seek accreditation to ISO Guide 25 and operate quality and testing systems which meet the requirements. The ISO Guide 25 approach heavily focuses on good analytical practices and adequate calibration of instruments with nationally or internationally traceable standards wherever possible. 

The second approach - creation of systems for non-destructive testing quality assurance in compliance with ISO standards 9000 series - considers the quality system as an assembly of organisational strueture, procedures, processes and resources necessary for overall quality management at the laboratory. This approach requires methodieal development. 

In compliance with the requirements stated in the System of accreditation to the practical experience and qualification the technical manager in NDT must have at least level 2 on each of NDT methods used in the laboratory seeking accreditation, where not more than 3 NDT methods are in practice, and level 3 on the basic method used in the laboratory where there are more than 3 methods. Moreover all specialists must be certified in relevant NDT method and industrial sector. 

Checking is performed in accredited laboratories on procedures developed in compliance with stated requirements and approved in the process of testing implementation on CTB 8001-93 or metrological attestation on CTB 8004-93. 

Wind Resistance. Asphalt shingles are certified to wind performance test standards on a continuous basis through independent third-party testing laboratories. Shingles that have passed the standard wind performance requirements, such as ASTM D3161, Standard Test Method for Wind Resistance for Asphalt Shingles, are identified by labels from the testing laboratory with whom they are in compliance. 

CHCS Compliance Engine Advanced Systems Laboratories, Inc. 7137 West Main St. Lima, NY 144SS (716) 624-3276 Assists with SARA Title 111 compliance. User inputs information and system provides compliance status and tasks required for compliance. 

Each contract laboratory used in the QPMBS and the organization that coordinated the field phase already had in place a well-defined GLP-compliant quality assurance program. In addition to these existing quality assurance programs, an independent QA specialist was engaged to ensure compliance of all the aspects of the smdy with GLP requirements. 

The study QA specialist visited each laboratory, conferred with the local QA specialist, and reviewed local practices and record keeping, thereby establishing that personnel and practices at each laboratory were satisfactory. Each laboratory, of course, remained responsible for internal compliance with the protocol and with GLP requirements throughout the study. 

Lab packs Laboratories commonly generate small volumes of many different listed hazardous wastes. Rather than manage all these wastes separately, labs often consolidate these small containers into lab packs. Trying to meet the individual treatment standards for every waste contained in a lab pack would be impractical. To ease the compliance burden, U.S. EPA established an ATS for lab packs that allows the whole lab pack to be incinerated, followed by treatment for any metal in the residues. Treatment using this alternative standard satisfies the LDR requirements for all individual wastes in the lab pack. 

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