GMP Quality Control & Batch Certification

Pensatech Pharma is authorised to do quality control testing (physicochemical and pharmaceutical analysis) as well as batch certification of finished and investigational medicinal products in its GMP-certified laboratories.

Meeting regulatory standards following GMP and ICH guidelines:

  • Comprehensive and well-documented quality control services

  • Testing and release of finished and investigational medicinal products according to monograph or customer specifications

  • Batch certification for sterile and non-sterile liquid and solid dosage forms

  • Development, optimization and validation of analytical methods

Pensatech Pharma is GMP certified by German authorities (EU GMP, most recently August 2020).

Capabilities

Conventional and sophisticated testing equipment is available for QC testing of drug products by compendial, non-compendial, in-house and customer-supplied methods.

 

  • Assay

  • Impurities and related substances

  • Content uniformity

  • Dissolution

  • pH, conductivity

  • Subvisible particles

  • Particle properties (size and shape 

  • Powder properties (bulk and tapped density, flowability)

  • Tablet friability and hardness

  • Disintegration time

  • Water content

For further information on our GMP services or to request our equipment lis or certificate, please contact us.