Compliant with major standards
All lab work and procedures comply with ISO17025, completed with EDQM guidance and GMP regulations. Storage conditions recommended in our studies are in accordance with ICH guidelines. Detailed procedures enable the management of all aspects of an analysis from receipt of the sample to release of the final report or certificate of analysis.
Our QC Laboratory is able to support your analytical needs from pharmacopoeial analysis of raw materials to finished products. HeW Pharma Labo can take over full analysis so that our customers can stay focused, even when they have limited internal capacity. HeW pharma Labo is equipped for the testing of a wide range of pharmaceutical forms (solid dosage forms, solutions, creams, oral sustained release forms, etc)
Method development and validation
We develop scientifically sound and cost-effective analytical methods in co-operation with our customers. Services facilitating liable QC testing provided to our customers:
- Development and implementation service for new products
- Transfer of existing methods
- Method Adaptation and Optimization
- Method Validation
HeW Pharma is able to develop and validate analytical methods in the PPM range to support your cleaning validation. If needed, we can come on-site to assist you in taking swabs for cleaning validation. Both chemical and microbiological swabs can be taken to assist your cleaning validation activities.
HeW pharma Labo tests the microbial quality of raw materials, cosmetics and pharmaceutical finished products:
- Microbial count (TAMC & TYMC)
- Exclusion of specified pathogens
- Efficacy of microbial preservation (PET)
- Microbiological assay of antibiotics
- Bacterial endotoxin test (LAL test)
Next to product testing, we are able to support our customers with the analysis of their purified water according to Ph. Eur.
If needed we can assist you in keeping your clean rooms qualified. We have active air sampling equipment and Qualified HeW Pharma staff can go to our customers to take samples. If guidance is needed for best practice on air sampling, monitoring of compressed gasses etc… we are there to help our customers.
Investigating the stability and shelf-life of a finished product is an important area of expertise at HeW Pharma Labo. We can assist you in defining the best approach for the study of the stability of your product, including accelerated testing, in-use or ongoing stability testing.
Storage conditions in accordance with ICH guidance:
- 25°C / 60%RH
- 30°C/ 65%RH
- 40°C/ 75%RH
All testing is performed in our laboratory under the supervision of an independent study coordinator who manages your project. Moreover, if requested you will receive complete documentation of the stability. You can rely on our consultancy for regulatory support and assistance in the submission of applications.
EU Import & QP batch release services
The analytical laboratory of HeW Pharma Labo has authorization for testing and release of raw material products. If requested, our own qualified persons can certify the batch release testing, in accordance with Annex 16 of the EU GMP Guidelines.
Also, companies that want to import products can rely on HeW pharma for EU product release. We take care of EU import release responsibilities for companies outside of the European Union.