Are you a GLP/GMP facility?
Are your methods validated?
Do you have a QA department?
Have you been inspected by the FDA?
Do you have ICH stability conditions?
How do you handle Out of Specification Results?
Are your registered to handle controlled substances?
Do you perform raw material testing and USP monographs?
How long does it take to develop and validate a stability indicating HPLC method?
What types of products does QTI have experience with?
Does QTI have experience with biotechnology products?

Are you a GLP/GMP facility?
QTI is an FDA, DEA and State of New Jersey registered laboratory. Therefore it is capable of providing services in compliance with cGMP regulations and guidelines. QTI operates within strict accordance to it’s in-house SOPs for instrument operation, maintenance, calibration, employee training, data storage, and document control.

Are your methods validated?
FDA and ICH validation guidelines specifically require that the methods be validated for their specific application. QTI specializes in validating methods for specific client needs.

Do you have a QA department?
Yes, currently QTI dedicates 10% of its staff to Quality Assurance. In addition each employee has a QA component as part of their job function.

Have you been inspected by the FDA?
Yes. QTI has an excellent reputation with the FDA. We have successfully completed a general compliance audit and two pre-approval inspections.

Do you have ICH stability conditions?
QTI maintains three walk-in environmental chambers set at the standard IC H conditions. These rooms are completely validated and are monitored 24 hours a day for compliance tospecifications. Our computer monitoring system and back up power generation system assure continuous performance Additional reach in stability chambers are available for client specific conditions.

How do you handle Out of Specification Results?
QTI policy dictates that it will follow the client procedure. If one is not provided, QTI will follow its own procedure for Out of Specification Results.

Are your registered to handle controlled substances?
QTI is licensed by the DEA and the State of New Jersey to handle all schedules of controlled substances.

Do you perform raw material testing and USP monographs?
QTI typically performs raw material and USP testing as part of a stability protocol or high volume release testing where there are large numbers of samples. It is usually not cost effective for our clients to send individual samples for analysis.

How long does it take to develop and validate a stability indicating HPLC method?
The total time from start of method development to final validation report is six to eight weeks. QTI develops methods in two to three weeks. This includes writing the method and preparing the validation protocol. The performance of the protocol usually takes an additional three to four weeks.

What types of products does QTI have experience with?
As a contract laboratory specializing in method development and validation, QTI has extensive experience with a wide variety of products including pharmaceutical formulations such as tablets, capsules, creams, ointments, parenteral solutions, lyophilized powders, syrups, and suspensions. In addition we have developed and validated methods for medical devices and diagnostics.

Does QTI have experience with biotechnology products?
Yes, QTI has developed validated methods for active proteins, peptides and nucleic acids. In addition we have developed validated methods for counterions such as TFA and acetate as well as impurities such as metals contaminants in these products.