GMP Method Development and Validation

PPD Laboratories GMP lab performs method development and validation for a broad spectrum of biopharmaceuticals and dosage forms across all phases of pharmaceutical development. Our experienced scientists provide method development, experimental design, method validation protocol development, gap analyses, remedial method validation and customized method validation reports. In addition, we have a full complement of GMP analytical testing resources and expertise to perform release testing and quality control analyses for active pharmaceutical ingredients and drug products in virtually all dosage forms and delivery systems.

Our service offerings include:

  • 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