Quality Assurance

The requirements on production equipment for the Health Care industry are to a great extent about being able to prove that the individual production meets the Danish and especially the requirements and expectations of the foreign authorities on a controlled and documented manufacturing process for the product in question.

Therefore Moeller & Devicon offer to carry out full quality assurance and qualification (validation) in connection with the consignments of the production equipment we supply.

Quality assurance of the equipment can comprise the preparation of FAT and SAT protocols, test plans and test diagrams at a level meeting all international authority require-ments including the guidelines of FDA too. Moreover Moeller & Devicon have broad practical experience in the performance of FAT/SAT tests both at home and abroad for some of the world’s leading pharmaceutical companies as Pfizer, Aventis, Novo Nordisk, Coloplast and others.

Besides the FAT/SAT activities Moeller & Devicon have broad experience in the carrying through/preparation of the following:

• Requirement Specifications
• Function Specifications & Design Specifications
• Quality Activity Plans
• FMEA Risk Analyses of mechanical equipment
• Identification of critical component parts
• Process flow analyses

Validation (Qualification Activities)

To be able to offer our customers a total equipment supply Moeller & Devicon have established a validation department which has specialized in carrying through the validation of production equipment also including general advice on authority require-ments, production maturity, and development of Medical Device products.

Moeller & Devicon offer the following work done:

• Identification of product critical conditions
• Identification of critical component parts
• Drawing up of Validation Plan (VP)
• Drawing up of Validation Report
• Design Qualification (DQ)
• Maintenance Qualification (MQ)
• Installation Qualification (IQ)
• Worst Case Analyses (WCA)
• Operational Qualification (OQ)
• Preparation of operator instructions (SOP)
• Performance Qualification (PQ)