GMP/GXP Service BAYEGI GMP-CONSULTING engineering office

-Planning / implementation of pharmaceutical clean rooms according to EU-GMP / ISO14644 / cGMP / VDI-2083

-GMP-compliant characterization of biopharmaceuticals, vaccines and further drog- production-processes such as: solids , Semi-solids, Liquids, Sterile dosage forms and Soft gelatin capsules

-Concept and project plan for the manufacture of advanced therapy medicinal products (ATMPs) (accordance with EU GMP Part IV)

-GMP-Validation / qualification according to EU-GMP (Annex 15)

-CS-Validation / qualification according to EU-GMP (Annex 11/Gamp 5 und FDA 21 CFR part 11)

-Validation / qualification for medical devices according to ISO 13485 (FDA 21 CFR Part 820)

-Planning and implementation of ventilation systems in accordance with ISO 16444, ASHRAE

-Creation of GMP-compliant qualification documents (DQ, IQ, OQ, PQ) for clean room, facility, HVAC, Computer System

-Design and implementation of process validation

-Project management of GMP-Projects

-Preparation and execution of supplier audits (FAT)

-Implementation or moderation, documentation of risk analyses (FMEA)

-GMP Implementation and preparation of employee training

-Creation, revision and testing of SOPs

-Analysis and communication of quality problems

-Concept and implementation of necessary CAPA measures

-Preparation and testing of cleaning validation

-Quality assurance checks (audit) at the customer's facility. Audit preparation

-Assessment of third-party quality assurance or qualification documents with regard to professional correctness, completeness, GMP conformity

-Manager Coordination of strategic and operational projects in the quality area (QA,QC)