Our product support services define who we are at R.D. Laboratories. Our mission is to support manufacturers, packagers, raw material suppliers and formulators with timely and accurate test results in nearly every phase of development from conception to the release of a safe and effective final product.
R.D. Laboratories has extensive experience providing both method development and validation services. Most often we are asked to develop a method for the analysis of an active drug substance in a finished product. Because HPLC instrumentation lends itself to automation, high sample volumes and accuracy at low levels, we typically prefer an HPLC procedure for method development because it allows for the separation of components, as well as taking full advantage of the Photo Diode Array Detector (DAD) to establish peak purity. In some cases, because of the nature of the analyte (mineral supplements, for example), we apply other testing techniques, such as Gas Chromatography.
For validation guidelines we use sources such as the ICH (International Conference on Harmonization), EP (European Pharmacopoeia) and USP (United States Pharmacopeia). These guidelines specify the typical analytical characteristics of data elements for validation testing. Depending on the particular test method and purpose (assay, impurity, degradation product, limit test, etc.), validations may include accuracy, precision, specificity, detection limit, linearity, range and robustness.
Vendor qualification plays an important role in any supplier’s or manufacturer’s quality program. To ensure cGMP compliance and prevent supplier quality issues it is ideal for an independent contract laboratory, such as R.D. Laboratories, to qualify every material ingredient contained in a product. This includes raw materials, active drug substances, packaging, solvents and any other processing reagents.
Process validations ensure batch to batch uniformity and quality, as well as beginning, middle and end of production run uniformity and quality. An important element of process validation is the elucidation and understanding of critical controls that impact the quality of a product. This understanding assures a quality finished dosage from batch to batch. R.D. Laboratories has the capability to test the large groups of samples typically associated with process validations.
The assignment of accurate expiration dating on pharmaceutical products requires stability storage and testing. R.D. Laboratories offers a wide range of temperature and humidity conditions for storage, both ICH and custom, and we perform a variety of light stability studies as well.
R.D. Laboratories has extensive experience adapting HPLC technology to meet the particular needs of our customers' protocols for cleaning validations, such as specificity and limit of detection.