PQM Consultancy Information

Consultancy in the Life Science Industry; www.PQMConsultancy.nl Fields of operation: - Audit; internal/self-inspection and external - Commissioning, Qualification & Validation of processes or systems - Project Management - Quality Assurance Management - Training (e.g. GxP, GAMP, Risk Management, Change Control, self-inspection & audit) 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, Quality, Food, Medical Device). 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) Inspection References: - Abbott Laboratories BV, Olst - ACE Pharmaceuticals BV, Zeewolde - AMO BV, Groningen - Astellas Pharma Europe BV, Meppel - Beenen BV, Heerenveen - CAF-DCF, Brussels (B) - Frieslandcampina Domo BV, Beilen - hmsBlistique BV, Heerenveen - Holland Pharma BV, Borculo - Imgroma BV, Diemen - Matrix Pharma BV, Lelystad - MSD Animal Health, Boxmeer - RIVM DVP, Bilthoven - Sanquin Plasma Products, Amsterdam - Sensofar Medical, S.L., Terrassa (ES) - Vaccinogen BV, Emmen - Van Os Healthcare BV, Bodegraven - Vemedia Manufacturing BV, Diemen