1. Analytical Methods :
Analytical Methods used for testing defined process steps, quality control data for batch release as well as monitoring of utilities and clean rooms are considered to be critical and have to be validated prior to implementation in routine procedures.
These methods predominantly concern the use of complex systems like HPLC, GC, and spectroscopic systems in
chemical analytical & microbiological laboratories and automated systems for
microorganism identification.
For these different methods Valicare offers the support in preparation of validation protocols based on the different international requirements (e.g.
ICH: International Conference on Harmonisation of Technical Requirements
for the Registration of Pharmaceuticals for Human Use) and which takes into account the intended particular use in your laboratory. Thus Valicare ensures GMP compliance of your laboratory either for EMEA or for FDA inspection of your facility.
Valicare offers support for execution of the validation protocol, establishing the validation report, handling of potential deviations, and their resolution in accordance with GMP requirements. If
desired Valicare supports you in optimising the method.
2. Incubation methods:
For storage and stability testing of finished, intermediate products,
and raw material samples temperature and humidity controlled rooms are
required.
Regarding microbiological testing, incubators for sterility tests and devices for
studies concerning viable counts and “media fill” units are utilised.
For cold and freeze rooms, as well as for incubators and stability chambers, documented evidence for suitability of the methods is required.
Valicare offers GMP compliant qualification and validation of the equipment and the incubating process,
including temperature distribution, determination of cold and hot spots, and checks for temperature stability by
"temperature mapping".
Our services include:
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GMP compliant protocol preparation including detailed test descriptions
- Test execution
- Treatment of deviations
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Preparation of the validation report
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Re-qualification according to fixed scheduling
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