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GLP Compliancy
GLP Compliancy

GLP Compliancy

Mass Histology Service Inc. is dedicated to preserving quality control among all of our laboratory workings. We guarantee that the pathology reports our clients receive from us will hold up to the Food and Drug Administation's (FDA) standards.

The following list describes what measures Mass Histo takes in order to ensure that all of our procedures conform to these standards:

Good Laboratory Practice: All work withing Mass Histo is conducted in adherence to the FDA’s section 21 CFR, Part 58, Good Laboratory Practice for Non-Clinical Laboratory Studies. These guidelines involve a series of regulated recordkeeping, reporting and quality control practices. This guarantees the quality and integrity of the data generated for our portion of your study. The FDA can (and has) perform non-scheduled audits to ensure this compliancy.  

Chain of Custody: All details are documented each time a specimen moves through our lab. We can look at our records to see who performed which step of the process and on which day. Lot numbers and temperatures are recorded and archived in fire-proof cabinates.  

Accountability: We strive to be completely accountable for all specimens that enter Mass Histo. Once we receive specimens, we log them in to our tracking program and assign your study a unique identification number. We then count the number of received specimens to ensure that the amount of specimens documented on the manifest and request has been received by our lab. This tracking program allows us to locate your specimens at all times. Each technician signs for the specimens at each step of processing and accounts for the number of specimens and their condition. If the number of specimens changes at any point, we can refer back to the person that last had them in their possession and we will find the missing specimen.

Study Auditing: Quality Control (QC) auditors verify every step of our procedures to ensure we are following all company Standard Operating Procedures (SOPs) as well as the instructions documented in the Experiment Protocol. This way, our clients can be assured that we have completed each step under FDA standards. The auditors verify each GLP study that the work performed at Mass Histo was free of deviations.

Annual Auditing: Our facility is inspected by an independent auditor on an annual basis. The auditor ensures that all equipment is in good working order and has been serviced and calibrated. All SOPs are inspected for proper signitures, chemicals and solutions are checked for expiration dates and all forms are reviewed for out-of-range deviations and signitures.  

Standard Operating Procedures: SOPs enable that all tasks performed within Mass Histo follow the same procedure to ensure consistent repeatability. Our SOPs are reviewed bi-annually in order to ensure procedures have not been altered. Every procedure that we perform at Mass Histo follows approved SOPs.  

Training Records: All new employees are trained on all of our SOPs and procedures and all employees are required to attend annual training seminars. Training records are available for every past and present employee. Documentation of their licensure and training records are stored in a fireproof file cabinet. These documents are available at any time for our clients of the FDA to review. Signiture files are also available on all employees.    

Mass Histology Service complies with the mandates of the FDA in order to generate credible work. Many laboratories are not GLP-compliant because of its additional labor and expenses. At Mass Histo, we put quality first. We adhere to all of these FDA regulations because we want to assure to our clients that they will receive the best histopathology available.

If you have any more questions about how Mass Histo's procedures hold up to FDA compliancy, please feel free to contact us. We would be happy to go over these mandates with you and you are welcomed to a scheduled site visit any time.