| Title: Analytical Laboratory Management | |||||
| Guidance Number: 90 | |||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Analytical Laboratory Management
Introduction
This document provides guidance for the management of analytical laboratories including the following:
- Personnel training;
- Proper handling of samples;
- Hazardous materials;
- Control and maintenance of reagents, reference standards, and buffers;
- Laboratory facilities and equipment; and
- Documentation and control of test results.
1. Work Surfaces (e.g., benches, fume hoods) should be clean and organized prior to, and after, use.
2. All Original Sample Solutions, Standard Solutions, Glassware, and Reagents used in the analysis, and in any subsequent investigation, should be retained to the extent possible if an analytical laboratory investigation (LI) is required.
Used testing materials and waste should be disposed of promptly, in a safe manner, and in compliance with local regulatory requirements, after the completion of testing and assurance that neither questionable results, nor Out-of-Specification (OOS) results have been obtained.
3. Analytical Laboratory Personnel Training should include the following, as applicable to the job function:
- Laboratory safety;
- Departmental Standard Operating Procedures (SOP);
- Analytical testing knowledge and skills;
- Preparation and handling of reagents and reference standards; and
- Laboratory documentation practices.
4. Calibration and/or Function Verification of laboratory instruments and laboratory equipment (e.g., balances or pH meters) that is performed should be documented and verified prior to use.
5. Laboratory Instruments and Equipment Requiring Repair or Calibration should be clearly marked and, when beyond repair, the equipment should be removed from the laboratory. A description of the malfunction, repair, or calibration of laboratory instruments should be documented.
6. Sample Handling, Testing, and Preparation of Testing Materials should be documented using a controlled documentation system.
7. Control of Laboratory Glassware should include the following:
- Glassware used for measurements should have the accuracy suitable for its intended use and shall conform to requirements of applicable compendia;
- A sufficient supply of glassware should be available for the number of tests to be performed;
- Clean and dirty glassware should be segregated;
- SOPs for cleaning glassware should be followed;
- Used glassware (e.g., pipettes, volumetric flasks) from critical stages of sample And standard preparations for chemical testing should be retained to the extent possible until there is a determination as to whether a result is valid or invalid;
- Glassware used for sensitive (e.g., optical) measurements should be cleaned by a method that has been determined not to interfere with the test to be conducted.
8. Approval of Contract Analytical Testing Laboratories by the Site Quality Authority should include consideration of the following:
- Historical performance of the contract laboratory, if available;
- Results of audit(s), if performed; and
- Use of the contract laboratory for routine or special testing (e.g., one time use).
9. When Contract Analytical Testing Laboratories are used for routine testing, there shall be provisions for the following:
- Sample controls (e.g., date shipped, date received);
- Sample retention requirements;
- Investigation and reporting of OOS and questionable results;
- Documentation and reporting procedures; and
- Periodic audits.