Good Laboratory Practices – GLP
Operation of STILLMEADOW, Inc.’s laboratory is designed around EPA, FDA, OECD and Japanese MAFF Good Laboratory Practices Standards (GLP) and guidance on quality assurance practices. All facets of laboratory operation are conducted according to established practices with appropriate documentation and quality assurance procedures. The following sections describe some of the key GLP components of laboratory operation.
GLP – Standard Operating Procedures
All routine laboratory operations are performed according to standard operating procedures (SOPs). SOPs are formal, revision-controlled documents that define the methods used in performing tasks that may affect data quality, findings, or conclusions. SOPs also provide standard methods for execution and documentation of tasks to maximize uniformity and reliability. They also facilitate coordination among individuals performing separate but interdependent tasks. If needed, forms may be attached to the SOPs for clarification. SOPs are available in the department where each task is performed. Each laboratory technician is trained in the performance of tasks described by SOPs, and training records are maintained for each technician. Laboratory procedures covered by SOPs include the following areas:
• Culture of test organisms
• Preparation of laboratory waters, solutions and reagents
• Calibration, operation, & maintenance of lab equipment
• Measurements for wet chemistry
• Receipt and documentation of samples
• Receipt and holding of test systems
• Cleaning and preparation of glassware
• Toxicity testing procedures
• Data recording and retention
• Quality Assurance.
GLP – Study Protocols
Studies and tests are conducted according to study-specific protocols that describe the design and methodology to be used in conducting a specific study. Before testing begins, study protocols are submitted to the client for approval. These protocols may be submitted to the appropriate regulatory agency for approval to ensure that the study procedures will be completely acceptable to the agency at study completion. Upon initiation by the Study Director, the study protocol becomes the key guidance document for all issues related to the study. If deviations from the study protocol are necessary to preserve the scientific integrity of the study, full documentation of the deviation is provided in the final report, along with a discussion of the implications of the deviation on the study result.
GLP – Data Recording and Retention
Study-specific data are recorded on appropriate data sheets that are designed for that purpose. Data from routine laboratory operations, such as sample receipt, organism culture, and equipment calibration and maintenance, are recorded in laboratory logbooks. Each laboratory sample, test system and material used is assigned a specific laboratory identification number that is included on all data sheets pertaining to that study. The study file documents all materials, test systems, organisms, and procedures used so that the study can be precisely reconstructed.
At study completion, all raw data and the final report are transferred to a completed study file that is identified by the laboratory study number and stored in the GLP Compliant laboratory archives. These archives are maintained in fire-protected, secure areas. Data pertaining to laboratory studies are retained in the laboratory archives for a minimum of five years, or as dictated by specific regulatory requirements.
STILLMEADOW, Inc. maintains a formal and active Quality Assurance (QA) program that provides a check on the quality of laboratory studies. While the QA program encompasses virtually every aspect of laboratory function, some specific parts of the program include:
• Procedural Inspections of Ongoing Studies: All GLP studies are inspected during the experimental portion of the study. Periodically, QA conducts unannounced inspections of laboratory procedures while studies are in progress. Items evaluated include adherence to SOPs and study protocols, cited regulations, appropriateness of scientific techniques, proper data recording procedures, and any other factors that might influence the scientific integrity of the studies. Results of these inspections are reported to both management and to the study director. Closed-loop corrective action is required.
• Facility Inspections: QA inspects the facility at least quarterly. Proper record keeping, facility cleanliness, and SOP and regulatory compliance are considered during these inspections. Results are reported to management.
• Quality Assurance Audits of Study Reports: Final reports are submitted to QA for evaluation prior to submission to the client. This evaluation provides assurance that the study was conducted according to the procedures described in the study protocol, and that the report accurately reflects the test data. Both the QA auditor and the Study Director sign the final report and it is submitted to the client.
• Laboratory Audits: STILLMEADOW, Inc. is subject to regulatory audits. These audits may be of particular studies, portions of studies, facility records, and general facility compliance with GLP.
STILLMEADOW regularly runs GLP studies in the areas of drug development, mammalian and environmental toxicology, animal health, entomology, analytical services, and in vitro studies.