Quality Assurance Services

product quality complaints, service complaints, inspections, capa, quality management system, qms, quality assurance, quality control, Good distribution practice, gdp, internal audits, training, deviation, local representative, change control, temperature monitoring, mah, marketing authorisation holder, thermal validation, thermomapping, IT validation, Business Continuity Plan, BCP, Gap analysis, support, Malta, Standard operating procedures, SOP, Quality Manual, Quality Policy, Work Instruction, Controlled documents, medical devices, Medical Device Regulation, MDR, 2017/745, iso certification, iso 9001:2015, In vitro diagnostic, IVDR, 2017/746, Unique device identifier, udi, serialisation, 2d barcode, declaration of conformity, doc, CE mark, labelling, artwork, mock up.
High quality and precision is essential in the Life Science Industry

We provide our expertise to support manufacturing sites and wholesale distributors in maintaining a Quality Management System in line with the Good Manufacturing Practice and Good Distribution Practice guidelines respectively. This is important to ensure that the quality of medicinal products is maintained to the highest standard during manufacture, storage and distribution.

Various other activities are performed such as:

    • Checking of product consignments before releasing to the market
    • Thermomapping of storage areas
    • Validation of Temperature monitoring systems
    • Supplier qualification
    • Product quality complaint handling
    • Recalls
    • Internal audits
    • Quality Risk Assessments
    • Advice on product verification and decommissioning requirements to be in line with the Falsified Medicines Directive
    • Advice and support in preparations for Good Distribution Practice Inspections
    • Identification and creation of Corrective And Preventive Actions and their effective implementation

Other Services: