For manufacturers of pharmaceutical products, qualifying systems and validating cleaning and manufacturing processes represent elementary components of the quality management system and are a condition for obtaining and maintaining the manufacturing license.
The substantial knowledge and manifold experience from different pharmaceutical segments means that the weyer group and its experts and specialists can offer you effective support in the planning and execution of the GMP activities required for this. This requires a risk-based approach in order to clearly define the scope of qualification or validation that is absolutely necessary.
In order to meet the strict requirements for quality, effectiveness and certainty that apply to pharmaceutical products, the experts from the weyer group always focus on compliance with the strict regulatory requirements for apparatus, processes and operating facilities that apply to pharmaceutical production.
We provide you with comprehensive advise in the qualification of pharmaceutical plants and pharma plant planning.
- GMP/FDA compliant validation
- Creation of master plans for validation and
- Qualification of pharmaceutical plants (VMP, QMP)
- Planning and implementation of the GMP risk analysis incl. Risk management
- Preparation of qualification plans for DQ, IQ, OQ and PQ
- Performance of qualification tests incl. Preparation of GMP-compliant documentation
- Validation of computerised systems according to GAMP
- Preparation of regulations and SOPs
- Preparation for and performance of supplier audits
- Support in planning and performing calibrations
- Performance of the change control
- Performance of the revalidation for periodically verifying the validated status
weyer special: Pharma
For many years, the weyer gruppe has successfully provided engineering, qualification and consulting services for customers in the pharmaceutical industry in Switzerland, Germany and internationally. Due to highly qualified engineers and technicians from different disciplines (process engineering, chemistry or mechanical engineering) with many years of project experience in the pharmaceutical industry, the weyer group can cover the complete engineering in the GMP environment from planning and realisation to commissioning and qualification…Download weyer special here