Van Kuppeveld Farma Consultancy can support in your surge for more cost-effective quality and being in compliance by improving quality and reducing loss of labor and material. VKC can assist you in the development, creation and implement ion of a quality management system.
GMP self inspection and auditing
Van Kuppeveld Farma Consultancy can perform and is world wide experienced in a wide range of audits from pre-inspection audits, process reviews, risk assessment audits, API supplier audits, raw material and packaging material supplier audits, contract manufacturing audits, CRO audits to automated system audits.
Van Kuppeveld Farma Consultancy can also support you in the development, implementation and execution of your audit program and your goal to certify your suppliers of starting materials as a cost and quality effective tool.
Van Kuppeveld Farma Consultancy can support you in the review, update and establishing your quality systems. If required we can support you in the development, implementation and maintenance of your system whereby we can support you in the goal to model your Quality Hand Book to the latest standards.
VKC can provide strategic and practical support in the field of validation like process mapping, risk assessment, preparation of Validation Master Plans, development of validation protocols and reports, review of validation documentation, cleaning validation and preparation of Product Annual Reviews
Van Kuppeveld Farma Consultancy has extensive experience within the field of pharmaceutical manufacturing, process control and pharmaceutical management. Based on this extensive experience we are always trying to identify the root cause of the problems. Besides this, VKC can support you in actions to implement corrective and preventive actions.
Interim Management & QP Services
Van Kuppeveld Farma Consultancy can provide you with interim management resources and QP services to support you in major projects, periods of high workloads and technical skill shortage. VKC can provide QP services related to solid dosage forms and sterile products according EEC Directive 75/319/EEC.