Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.
GLP Procedures at BioEngineering Solutions
Definition of Good Laboratory Practice
1. Control. BioEngineering Solutions provides assurance that your samples and test materials are received and handled in accordance with FDA guidelines, which require documentation and procedures to ensure error-free sample tracking. To accomplish this level of control, BIOENGINEERING SOLUTIONS has:
a. Physically separated receiving, testing, general storage and archival areas
b. Implemented a comprehensive sample documentation protocol that includes written and electronic receipt logging, tracking, running inventory and archiving of all GLP samples.
c. Provided physically separate dedicated workbench space (including a class 100 laminar flow hood) for all GLP activities.
d. Implemented an effective laboratory cleanliness policy to prevent contamination including the use of a hepa-flitration system.
a. Generated standard operating procedures for all laboratory equipment involved in GLP research.
b. Provides frequently scheduled inspection, maintenance, cleaning and calibration for all laboratory equipment involved in GLP research.
c. Calibrates all equipment both before and after GLP related testing.
d. Established comprehensive standard operation procedure (SOP) for the recording of all data that is designed to prevent recording errors.
3. Security. BIOENGINEERING SOLUTIONS provides assurance that your data is secure. BIOENGINEERING SOLUTIONS has:
a. Implemented a secure virtual space for all GLP data that can only be accessed by authorized personnel.
b. Provides offsite backup of all computer data.
c. Provides secure archiving of laboratory notebooks and samples.
4. Accountability. To guarantee that all protocols, SOPs and procedures are implemented properly, BIOENGINEERING SOLUTIONS has:
b. Generated a documentation system designed to follow each GLP project step-by-step through to completion.
5. Comprehensive reporting. Methods, results and data for all laboratory tests will reported in accordance with FDA guidelines including:
i. Descriptions of all procedures, including statistical methodologies
ii. Descriptions of all conditions that may have influenced the quality or
integrity of the data
iii. Descriptions of all operations performed on collected data
b. A statement of any conclusions drawn from the results or analysis.
c. Signed and dated reports from each scientist involved in the study.
