active ingredients, excipients, starting materials, primary and secondary packaging materials, final dosage forms and service providers: We will be pleased to perform your audit in all GxP-regulated areas, either individually on your behalf or as part of a shared audit.
GMP/GDP medicinal product supply chain
Active ingredient and contract manufacturers have been subject to audits for many years now. However, audits for excipients or Key Starting Materials represent relatively new challenges in these fields. We will be pleased to support you on the basis of the latest standards and rules for suppliers and service providers.
The GDP guideline for finished medicinal products came into force in 2013, followed by the GDP guideline for active ingredients in 2015. This has ushered in a whole range of new challenges in terms of audits. We audit forwarders, distributors, consignment warehouses and other service providers on the basis of the GDP guideline.
Not new, but always up-to-date: Packaging manufacturers are also subject to audit. This applies both for primary packaging materials under ISO 15378, such as blister packs, tubes or ampoules, and also secondary packaging materials (in line with GMP Part I and ISO 9001), such as folding boxes and other outer packaging.
Social and environmental audits
Fairly paid work, reasonable measures to protect people and the environment – these are taken for granted in Europe, but we Europeans may have doubts about how things are done in some third countries. On request, we will inspect social and environmental standards as part of a GxP audit. If you would like to know more, we will be pleased to provide further details.
In addition to our standard offering, we will also be delighted to customise our services to suit your needs. Whether it is a mock inspection as preparation for an inspection by the authorities, a for-cause audit or an internal self-audit or gap analysis, we have the perfect solution for you and we look forward to receiving your request.
We will be happy to offer our audit experience in the form of consultancy projects. Whether you are setting up QM systems or implementing new rules, we will support your company in implementing the latest GMP standards.