STILLMEADOW, Inc. – Drug Development, Toxicology, Animal Health
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.
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.
Quality Assurance