Qualified Person · GMP
Qualified Person for GMP (QP), Belgium.
Two ways to engage MEDCOR: as a named QP taking legal responsibility for batch release, or as an experienced pharmacist getting your GMP systems and audits in order. Same person, either way.
Named QP for batch release
Where the engagement calls for a named Qualified Person, MEDCOR takes legal responsibility for batch certification and release under your manufacturing or import authorisation.
GMP compliance and audit
Where you need the systems behind GMP in order, MEDCOR provides compliance support, audits ahead of an inspection, and builds the quality systems that sit underneath GMP and GDP operations.
When you need this
You need a Qualified Person if you hold a manufacturing or import authorisation and need batches certified and released under GMP. Companies also engage MEDCOR for GMP compliance support, for audits ahead of an inspection, or to build and audit the quality systems that sit underneath GMP and GDP operations.
What this covers
- —Acting as Qualified Person for batch certification and release, where the engagement calls for a named QP.
- —GMP compliance advice and support across your operation.
- —Auditing of manufacturing and distribution activities.
- —Standard operating procedures and technical agreements written for regulatory compliance.
- —Authorisation support, including wholesale distribution, psychotropics, export declarations and GMP certificates.
- —Setting up and auditing ISO 9001 and ISO 13485 quality management systems.
How it works
Whether you need a named QP taking legal responsibility for release, or an experienced pharmacist to get your GMP systems and audits in order, you work with the same person throughout. No hand-offs, no off-the-shelf systems, and a single point of accountability for your GMP compliance.
MEDCOR's other services
Need a Qualified Person for your products?
Named QP release or GMP systems in order, tell me which and we will take it from there.
Get in touch