QP-Engineering

GMP service from a single source: consulting, planning, qualification

With our services, we bring cross-industry expertise from pharmaceutical and medical technology, including analytics, to your company - specially tailored to your needs! Planning services - From the initial idea to the finished system: we support you with planning, implementation, control, commissioning and documentation. Qualification and validation - We support you with validation studies, the qualification concept, design, installation, functional and performance qualifications and the re-qualification of plants, systems and equipment. Cleanroom measurement technology - Our tests in accordance with ISO 14644 and EU GMP guidelines Annex 1 include Air quality (particles and germs), air flow (volume and velocity), air pressure difference, air flow visualization, temperature and relative humidity, microbiological air and surface contamination, leakage and filter integrity.

Good to know: GMP stands for "Good Manufacturing Practice", which is a quality assurance standard. GMP is required by law in the pharmaceutical and life science sector and is regularly checked by audits. QP-Engineering supports you with GMP audits and the implementation of all GMP standards in your company.

Specifics

1. Planning services - creation of room layouts, material and personnel flows, specifications and URS (user requirement specifications)
2. Qualification and validation of facilities/systems/equipment for solid and liquid forms as well as cleanrooms
3. Cleanroom planning - pressure zone concepts, hygiene zones, airlocks, cleanroom classification
4. Cleanroom measurement technology according to ISO EN 14644 and Annex1 - smoke studies | air purity | surface purity | volume flow rates and pressures
5. GMP training - pharmaceutical water systems, qualification of cleanrooms, GMP basic course (EU GMP Part 1, focus on production), qualification and validation (EU GMP Annex 15), data integrity, contamination control strategy (CCS), computer system validation (CSV), digitalization strategy / Pharma 4.0, sterile manufacturing (EU GMP Annex 1)