Laboratory
Quality control

Quality control in the pharmaceutical Industry

Quality control is a crucial aspect in the pharmaceutical industry to ensure the safety, efficacy and quality of medicinal products. This process involves a series of rigorous procedures and tests that are carried out from the initial stages of drug development through to manufacturing and distribution.

Our range of quality control services

HWI specialises in the testing of medicinal products, active pharmaceutical ingredients, excipients and medical devices. Development, manufacturing and testing require the utmost precision and care. The requirements for manufacturing and testing as well as ensuring the quality of processes and products in the EU are set out in the European Commission's GMP guidelines.

Our quality control services include:

Stability testing

We offer stability tests for finished medicinal products and active ingredients in accordance with the valid guidelines in the European and international environment.

From first clinical phase to on-going or follow-up stability of authorised medicinal products, we provide you with tailor-made solutions according to your requirements.

Our range of services

Stability studies

Our competent team develops matrixing and bracketing designs to efficiently conduct stability studies. We understand that each project is unique, which is why we provide you with customised methods. We perform in shell-life stability and photostability studies and advise you on stability concepts and runtime specifications in product development and lifecycle management.

Stability storage

Your samples are in safe hands with us. We offer GMP-compliant storage at various temperatures and humidity conditions, including

25 °C / 60 % relative humidity,
30 °C / 65 % relative humidity,
30 °C / 75 % relative humidity,
40 °C / 75 % relative humidity,
2-8 °C ,
as well as deep-freeze storage from -18 °C up to -80 °C.

If you require special climate conditions, we will be happy to implement them according to your specifications. Our state-of-the-art climate chambers and cabinets are monitored around the clock in compliance with GMP.

Stability management

We have many years of experience in conducting stability studies and take over the entire stability management. This includes the preparation of result reports, assessments and tabular and graphical evaluations. If required, we can enter the results directly into your templates and/or CTD modules.

Quality management

For more than 30 years, we have been conducting stability studies of pharmaceutical products under GMP conditions and in compliance with ICH guidelines. Our service ranges from the first clinical phase to the ongoing monitoring of authorised medicinal products. Our climate chambers are equipped with state-of-the-art technology.

Logistics and distribution

We have extensive capacity in our climate chambers to store even large registration stabilities, if necessary at short notice. We carry out the logistical handling and distribution of your samples with qualified logistics companies.

Batch release

We hold a manufacturing authorisation according to section 13, paragraph 1, of the German Medicinal Products Act (AMG) for the release of drug products. This enables us to conduct analytical testing for the batch release and EU release of active ingredients and finished products in our GMP- and FDA-certified lab.

Further information can be found under QP services.

Comprehensive quality control for pharmaceutical products

Our experts in GMP quality control test your medicinal products in accordance with international scientific and technical standards.

We use the latest technologies and methods in efficient processes. Whether you need a finished drug product or an active ingredient, we have the right solution for you.

Get in touch with us.