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PharmaGMP Testing – GBA Pharma LabsMicrobiological Analysis – Pharma (cGMP)


New Services (cGMP)

  • Performing Chromogenic Assays (e.g. Heparin according to Ph.Eur. 2.7.5 and USP <208>; ELISA for Penicillins)
  • Endotoxin Testing according to Ph.Eur. 2.6.14 (Methods C, D) and USP <85> using Turbidimetric and Chromogenic Methods

Tests in accordance with Ph.Eur. (cGMP)

  • Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests acc. to 2.6.12
  • Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms acc. to 2.6.13
  • Microbial Examination of Herbal Medicinal Products for Oral Use and Extracts Used in Their Preparations acc. to 2.6.31
  • Bacterial Endotoxins acc. to 2.6.14 (Method A)
  • Microbiological Assay of Antibiotics acc. to 2.7.2
  • Efficacy of Antimicrobial Preservation acc. to 5.1.3
  • Water, Purified (Aqua purificata; Monograph 0008)
  • Water for Injection (Monograph 0169)
  • Water for Preparation of Extracts (Monograph 2249)

Tests in accordance with USP (cGMP)

  • Chapter <51> Antimicrobial Effectiveness Testing
  • Chapter <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Test
  • Chapter <62> Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms
  • Chapter <81> Antibiotics-Microbial Assay
  • Chapter <85> Bacterial Endotoxins Test

Additional Services

  • Product-Specific Validations (acc. to Ph.Eur. and USP)
  • Development and Validation of Rapid Test Methods (e.g. Simplate®)
  • Microbial Assay of Vitamins
  • Identification of Germs

Microbiological Tests - Hygiene Monitoring (cGMP)

  • Sampling by Trained Stuff
  • Investigation
  • Germ Identification to Genus Level (Identification on a Species Level can be done via Subcontracting)
  • On request we can supply the necessary additional information about detected bacteria and their possible sources of contamination

The experienced and highly committed GBA Pharma Labs team offers a variety of different services in the following Areas.

GBA Pharma Labs – GMP Testing


GMP Quality Control

Method Development & Validation

Stability Studies


Extractables & Leachables

Packaging Material Testing

Particle Determination

Elemental Impurities Testing


Regulatory Services

Amino Acid Analysis


GBA Pharma Labs Trace-level analytic for N-nitrosamines


GBA Pharma Labs qPCR


GBA Pharma Labs iCEF


GBA Pharma Labs Protein characterization

Protein Characterization

GMP Testing

Contact us!

To learn more about us and what we can do for you please contact us.

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