Method Development and Validation

Analytical Method Development and Validation Before the analysis of leachables samples, a test method must be developed and validated to ensure that the analytes of interest are not obscured or affected by the formulation of the drug product. Appropriate analytes of interest for testing are to be dertermined. Drawing from resources available in literature, or performing extractables profiles in chemistry laboratory, specific analytes of interest for a drug product are determined. Methods are developed for these analytes in the presence of drug product, ensuring that any samples preparation procedures are incorporated into these methods. Following development, the method is then validated per ICH guidelines. Various studies involved in validation services include: linearity testing, precision (repeatability and intermediate precision testing), accuracy, specificity, limit of detection, limit of quantification, range, robustness and stability of test solutions. Different techniques with a multitude of drug product solutions are Gas chromatography (GC), Gas chromatography/mass spectroscopy (GC/MS), High-performance liquid chromatography (HPLC), High-performance liquid chromatography/mass spectroscopy (HPLC/MS), Inductively coupled plasma (ICP) spectroscopy, Ultraviolet/visible (UV/VIS) spectroscopy etc. New Sterilization Process Development and Characterization Solutions for FDA’s requirements for the testing required for a 510(k) submission for a new sterilization process can be provided by the laboratories. Biological and chemical indicators development, perform testing to prove that the sterilizer and sterilized materials are safe, and investigate the toxicity of any residuals. Laboratories GMP labs perform method development and validation for a broad spectrum of biopharmaceuticals and dosage forms across all phases of pharmaceutical development. Apart from method development, experimental design, method validation protocol development, gap analyses, remedial method validation and customized method validation reports may also be provided. Method development and validation for chromatography techniques including HPLC, UPLC, GC, SEC and IC with a variety of detection technologies including UV, DAD, FL, MS, ELSD, RI, PAD, FID, TCD, MALS, CAD Method development and validation for stability-indicating assays and related substances methods for drug substance and drug products, such as, tablets, capsules, suspensions, creams, injectables, nasal sprays, pMDIs, DPIs, medicated feeds, drug-eluting stents Method development, validation and quality control services for: Dissolution (IR, ER, MR), Organic volatile impurities, Preservatives and antioxidants, Clinical comparator assay and dissolution. Analytical support for process and cleaning validation on various surfaces by HPLC, UPLC, TOC and GC, Dose verification for GLP studies, Bioequivalency, in vitro pharmaceutical equivalency testing. Quality control support for Dosing solution analysis for toxicology studies, Customer product complaint testing, Field monitoring testing, Generation of statistical quality control charts.