Quality management involves all employees in your company and is based on the 'quality by design' principle in development. Structured approach (DQ, IQ, OQ and PQ) and qualification during the investment facilitates operation. Process capability in production shows efficiency and reliability. Knowledge of the (true) customer needs, determination of the critical quality attributes, as well as identification of the related material attributes and process parameters are essential in all areas. We support with Figures–data–facts-based risk assessments, development of appropriate actions in order to avoid defects, respectively reduce process variability.
Excellent audit results are your best advertisement. Complaints can massively affect your market viability respectively result in unplanned high binding of resources for remediation. Good preparation helps you perform well in the audit. We help you in weak point analysis, assessment of systems and their implementation. We support you with the preparation and during the audit in the back office.
Cross-Contamination Cleaning Validation
Safety of patients and prevention of contamination of drug products and active pharma ingredients are fundamental requirements for medical products. The focus of the authorities on cross-contamination and cleaning validation has rapidly increased since the EMA Guideline for qualification and Validation (annex 15) and Guideline on setting health based exposure in shared facilities has become effective. We have knowledge about the new guidelines, experience with high sensitizing substances (e.g. beta-lactam antibiotics) and support you in risk management, planning and implementation of appropriate actions.
Official Guidelines demand periodic auditing as part of the supplier qualification. Systematic investigation of the implemented actions and adequacy and effectiveness for the expected targets are an important part of your risk management. We support you with effective audits in accordance with general guidelines and your specific guidelines.