We offer
Qualified person (QP)
Book now your Qualified Person (QP) for Switzerland and be assured that an expert takes care of your products and reporting.
What we offer
best used for:
- Start-up's and established companies
- Companies with a hiring freeze
- Restricted budget
- Products with no assigned QP
- Bridging gap till hiring a QP/FvP
As a service, Avanti Europe will provide a dedicated expert in the role as your QP or Responsible Person (RP). The QP can be booked as part-time resource in full compliance with Annex 16 of EU GMP.
Our experts in the role of your QP comply with the qualification demands from the Medicinal Product Directive (MPD) 2001/83/EC Article 49. The role of the QP will cover the aspects of:
- Releasing batches
- Controlling batch release
- Certifying batches under EU regualtions
- Control outsourced activities under EU GMP
- Confirming compliance with specifications in cases of unexpected deviations
How it works
Required Information:
- Governing documents
- Process descriptions and SOPs
- Product documentation and specifications
- Change and CAPA log
- External manufacturing and audit reports
Our experts acting as QP under your pharmaceutical quality system (PQS) require access to documents and information in order to fulfill their tasks best. Digital access is here the best choice but thanks to our versatile approach, paper documents can be used as well.
An Avanti Europe expert acting as the QP needs access to at least the following documents:
- Governing SOPs and policies
- Product specific documents and process descriptions
- Any changes to processes and products
- Product documentation
- Documents regarding the release of the products
- Audit reports and external manufacturing list
The costs
Cost structure:
- Transparent costs
- Simple billing structure
- Scalable with small price steps
Costs are transparently fixed at the beginning of a term. A term can be individually set or prolonged with a minimum of 6 months in order to benefit from the tool set of a QP and its expertise.
Depending on the volume of documents and number of products, the QP can be booked starting at a very low work load percentage. Depending on demand, further development, expansion of the market or alike, the QP resource can be easily scaled to the demand.
