PQM Consultancy
Pharmaceuticals - Meppel, Drenthe, Netherlands
PQM Consultancy Employees
PQM Consultancy Details
Consultancy in the Life Science Industry; www.PQMConsultancy.eu((bio)Pharmaceutical, Medical Food, Medical Device)Fields of operation:- Audit; internal/self-inspection and external- Commissioning, Qualification & Validation (e.g. equipment, computerized systems, process, utilities)- Project Management- Quality Assurance Management- Quality Systems Management- Risk Management- Training (e.g. GMP, GDP, GAMP, Risk Management, Change Control)In all industries guidelines and/or regulations apply to ensure that the quality of products and/or services are guaranteed. Performing an internal regular audit is a way to validate if your company is still working according to the procedures, guidelines and/or regulations. But also control of suppliers can be validated with an audit. Within PQM Consultancy extensive experience is available to perform audits at different levels (e.g. ISO, GxP, Excipients, quality, CISA, Food, Medical Device). PQM Consultancy has two consultants which are IRCA certified Pharmaceutical Quality Management Systems (PQMS) Auditor/Lead Auditor.Support can be provided in the following areas: - Development of audit programs, based on a risk-based approache, and audit reporting - Perform internal audit / self-inspection - Executing external audit of your service provider (s) regarding raw materials, excipients, materials, services (including outsourcing ICT, maintenance, testing laboratories) - Preparation and/or monitoring of audits, e.g. (government) InspectionReferences:- Abbott Laboratories BV, Olst- AMO BV, Groningen- Astellas Pharma Europe BV, Meppel- Beenen BV, Heerenveen- CAF-DCF, Brussels (B)- DFE Pharma, Goch (D)- Frieslandcampina Domo BV, Beilen- hmsBlistique BV, Heerenveen- Holland Pharma BV, Borculo- Milupa GmbH, Fulda (D)- MSD Animal Health, Boxmeer- Purac Biochem BV, Gorinchem- Sanquin Plasma Products, Amsterdam- Sensofar Medical, S.L., Terrassa (ES)- SHS International Ltd., Liverpool (GB)- Vaccinogen BV, Emmen
