Pharmaceutical Testing – Sterility, Pharmacopoeia, Stability & GMP

A worker operates an oil extraction machine in a laboratory production setting.

We support pharmaceutical manufacturers and suppliers with accredited analytical testing in accordance with DIN EN ISO/IEC 17025, GMP-compliant testing (§ 14 Abs. 4 AMG), and expert regulatory consulting. The focus is on safe, effective, and high-quality pharmaceutical products throughout the entire product lifecycle, in accordance with the European Pharmacopoeia (Ph. Eur.) and further international Pharmacopoeia. Methods are implemented, verified, or validated accordingly and interpreted with technical accuracy.

Our comprehensive, GMP-compliant documentation ensures data integrity, thereby guaranteeing reliable stability and quality assessments in the pharmaceutical sector.

View Matrices

Conducting microbiological analyses such as test for sterility, test for bacterial endotoxins, identification of microorganisms, test for efficacy of antimicrobial preservation, growth promotion test, and Microbiological examination of non-sterile products in accordance with pharmacopoeial guidelines. These analyses are crucial for assessing the microbiological safety of sterile and non-sterile pharmaceuticals. They support quality assurance throughout the production process.

Conducting pharmaceutical chemical quality control of raw materials and finished pharmaceutical products in accordance with the European Pharmacopoeia, the United States Pharmacopoeia (USP), and customer-specific requirements. This includes release and stability testing in accordance with ICH guidelines, method development and validation, as well as the characterisation of reference substances and the structural elucidation of unknown impurities. In addition, we offer specialized analytical services like vitamin, amino acid, and elemental impurity testing.

Environmental and cleanroom monitoring serve to continuously monitor hygienic conditions in pharmaceutical production environments. Ifp Labs provides support through air and surface sampling as well as further hygiene indicators, a modern monitoring concept that also includes the assessment of environmental factors such as water quality and cleaning processes.

Yes. We can implement customer-specific test specifications. Test methods, limits, and documentation requirements are adapted and validated according to customer specifications. Upon request, ifp Labs also provides support in creating or optimizing these specifications.

Yes. We have extensive experience in managing individual projects, ranging from one-time specialized analyses to complex development and validation projects. Clients receive personalized project support as well as transparent time and cost planning.

Yes. We offer express or priority processing for many types of analyses. Availability depends on the specific method and sample type.

We assist customers with root cause analyses, repeat testing, extended analyses, MALDI-TOF identification of microorganisms, and the evaluation of results in accordance with GMP and regulatory requirements.

More FAQs