Quality management (GxP)
Diapharm provides quality management, quality control and quality assurance services. We provide advice on implementing good practice (or GxP) guidelines – and we ensure compliance.
GxP: proven quality
Pharmaceutical quality management systems cover all aspects of a product’s life cycle, from development to patient use. Quality assurance measures, known as “good practice”, are in place for every step along the way.
These include good manufacturing practice (GMP) guidelines, which were first published by the WHO in 1968 and have since been amended and expanded on several occasions. The EU GMP Guidelines outline the GMP rules applicable in the European Union. There are also similar EU guidelines for the distribution of medicinal products (good distribution practice, GDP) and drug safety monitoring (good pharmacovigliance practice, GVP). A company’s Qualified Person (QP), or its Qualified Person for PharmacoVigilance (QPPV), is responsible for ensuring compliance with GxP guidelines.
Diapharm supports pharmaceutical companies and their QPs in efficiently integrating these standards into their own quality management systems, complying with GxP guidelines and proving compliance to regulatory agencies during inspection. We develop complete GxP quality management systems and provide advice on quality assurance.
Our good practice services:
- Advice on good manufacturing practice (GMP), good distribution practice (GDP), etc.
- Gap analysis
- Preparation and maintenance of pharmaceutical QM systems
- Risk management and FMEA
- Audits and inspections
Qualified Person: we take on repsonsibility
Diapharm’s QP service provides pharmaceutical companies with an experienced partner to support them in complying with their duties as outlined in the German Drug Law (AMG) – long term or short term to bridge the gap during staffing transitions or fill in while employees are on PTO/holiday leave. And we go one step further: we take over the responsibilities that manufacturers of medicinal products and investigational medicinal products face, including batch release and/or EU import release by our QPs. Get in touch with us!
Did you know? Our Qualified Persons travel the world to audit (contract) manufacturers on behalf of pharmaceutical companies. Hundreds of third-party audit reports are available for purchase.