According to the FDA, the pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertains to the quality control laboratory and product testing. Therefore, the laboratory you choose can make a huge difference in helping you get market approval for new products, avoiding costly delays in submissions, approvals, recalls or interruptions in manufacturing.
NJ Labs has expertise across a wide range of testing for the pharmaceutical industry, with an eye towards trends that are becoming more of an issue with the FDA. A recent example is that of Suitability testing, which determines the ability of test methods to detect the presence of microorganisms in products that may be inherently antimicrobial. Another example is that regulations for heavy metals testing (Pb-Lead, As-Arsenic, Cd-Cadmium, Hg-Mercury) are now required to be done by USP<233> which is ICP-MS rather than more traditional wet chemistry methods. We also have the expertise for Fatty Acid profiles for oils as many pharma companies use fatty oils as fillers or bonding agents like Polysorbate 60, 80 and many more. Our assays of APIs and Finished drug products use a compendial method, confirming the ability to produce reliable and reproducible results by USP <1225> and USP <1226> and the list goes on…
Our goal is to help our clients avoid Deficiency Letters by anticipating issues of concern to the FDA. However, if you have received an FDA Deficiency Letter and need help addressing the issues raised, please reach out to us. We have helped many clients test for the deficiencies identified by the FDA, and provide responsive reports addressing the deficiency letters within the required timeframe.
Learn more about the specific testing we offer here.