GxP Services/ Regulatory – Compliance

GxP stands for quality management (QM) systems in the areas of pharmaceuticals, chemistry, biotechnology, food (U.S.A.) and medical devices as well as their suppliers and contractual partners.

The pharmaceutical quality assurance system (PQS) represents the entirety of all measures taken to ensure the required quality of medicinal products for their intended use. An effective PQS cannot therefore be a “one-off performance” for, for example, obtaining a manufacturing permit, but must be tracked and continuously improved throughout the entire product life cycle.

An effective PQS should ensure product realization, control and monitoring as well as continuous improvement (GMP Guide Part III, Q10 Note for Guidance on Pharmaceutical Quality System). To implement, maintain and monitor, an effective PQS has the following elements and tools:

 

PQS Diagram

We would be happy to support you in developing an effective PQS. This also includes a content review of existing systems and work instructions (SOPs). We convert proven individual work processes into standardized and practice-oriented processes. Our goal is to uncover potential for improvement and to consistently implement a risk-based approach.

We also offer:
• Conduct self-inspections
• Preparation, support and follow-up of official inspections
• Compliance checks to examine manufacturing processes, qualifications and uncover potential for improvement.

Our diverse and practical expertise lies in the area of ​​classic pharmacy (GMP, GDP) and medical devices.