cGMP Testing Services

Home cGMP Testing Services

Whether you’re starting from scratch with a brand-new product or trying to improve on an existing drug delivery system, Tergus offers a flexible suite of cGMP testing services to meet your regulatory, quality, and/or product requirements.

Stability testing

  • Six walk-in stability chambers at ICH conditions
  • Dedicated stability coordinator
  • Remote alarm monitoring of chambers with back-up generators

Microbiological testing

  • Microbial limit test (MLT)
  • Anti-microbial effectiveness test (AET)
  • Method validation: suitability test
  • USP
  • EP/BP

In-vitro release testing (IVRT)

  • Release and stability testing per FDA/SUPAC-GMP guidelines
  • Product bioequivalence testing
  • Method transfers or method development/validation
  • Testing of topical formulations including gels
  • creams
  • lotions
  • and sprays
  • Hanson Franz cell instrument housed in the GMP QC lab

Analytical testing

  • Raw materials testing – compendial and non-compendial
  • Bulk and finished product release testing
  • Residual solvent analysis


For certain level changes in approved products—such as site transfer, changes in excipient supplier or grade, and some other such changes—SUPAC-SS guidance requires an IVRT to be performed to compare equivalency between batches. The FDA has stated in the SUPAC-SS Guidance document that “in vitro release testing has shown promise as a means to comprehensively assure consistent delivery of the active component(s) from semisolid products.”

The SUPAC-SS Guidance is applicable to the following regulatory submission types:

  • New Drug Applications (NDAs)
  • Abbreviated New Drug Applications (ANDAs)
  • Abbreviated Antibacterial Drug Applications (AADAs)