Quality Assurance & Control

Northeast Laboratory Services produces and packages microbiological culture media at a facility inspected by the Food and Drug Administration for compliance with the current Good Manufacturing Practices regulations for Medical Devices and Diagnostic Products, CFR 21, Part 820.

Compliance with the CLSI Standard M22-A3, Quality Assurance for Commercially Prepared Microbiological Culture Media, M100-S22, Performance Standards for Antimicrobial Susceptibility Testing, and M02-A11, Performance Standards for Antimicrobial Disk Susceptibility Tests are criterion for release of in vitro diagnostic products. Products must meet the characteristics specified in the CLSI Standards before they are released for shipment to our customers.

NEL QC department also performs customized quality control testing. Product specific organisms and growth challenge levels are available to meet specific requirements, including procedures which follow strict USP guidelines. Sterility confirmation testing with specified temperature and duration may also be designed to meet unusual needs. Products are also checked for proper pH, weight, fill, and physical analysis.

All product testing is certified on product/lot specific certificates of analysis (COA), which are available for each manufactured lot.

The FDA requires NEL to keep device history records. These are written documentations from the minute a product is ordered right down to the very end of manufacturing, which documents every step of the manufacturing process. It shows who did what and when. It tells how much of an ingredient was added, product number, product lot number, when it was added, dates, times, and the list goes on. Without these records, as far as the FDA is concerned, none of the steps were done, which is why we must adhere to making sure the device history records are properly filled out.

The NEL QA/QC department also writes up and maintains Customer Complaints, Discrepancies, and Corrective Action Plans. We also are available to answer technical questions about media performance or problems. If a customer is having a problem with one of our products, we try to duplicate what the customer is seeing by pulling retention samples of the same lot number that the customer is having technical issues with and help the customer solve the problem.

The NEL QA/QC department strives to release a quality product to our customers.