SERVICES
PharMedica d.o.o
11000 Beograd,
PALMOTIĆEVA 3/4,
Tel/fax: +(381) 11 71 50 582,
+381 11 71 50 589
+381 11 33 40 164
office@pharmedica.rs
GMP consulting
Language:
Our sector for the qualification / validation in the field of GMP - Consulting can offer the following services:
- Expert support when considering treatment and selecting solutions that are in accordance with GMP principles related to production, applied for technology, equipment and products.
- Optimization solutions from the point of GMP, the separation of flows of raw materials, finished goods and personnel for the pharmaceutical manufacturing
- Interpretation of international and national standards for the requirements of GMP (GMP ES, Fire the, PIC, WHO, Gump, FDA).
- Validation master plan (VMP)
- Risk Analysis (RA GMP, HAZOP, FMEA)
- Project Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Process Validation (PV)
- Cleaning Validation (CLV)
- Validation of analytical methods (AMV)
- Validation of computer systems (ComVal)
- Revalidation
- Training staff on issues of investor bases GMP, hygiene in the pharmaceutical manufacturing, qualification / validation, clean rooms, pass, the concept of hygiene zones, records, etc.