Contract QP named on your MIA / MIA(IMP) Licence Under European Pharmaceutical legislation, a Qualified Person named on the relevant Manufacturer’s / Importer’s Authorisation (MIA) must certify each manufactured or imported batch of medicinal product, before it can be released to the market or used in clinical trials. BioChem QP Consulting can provide this service either as ongoing back-up for your existing QP(s), or for smaller organisations and start-ups, to act as your main QP while you build your business to the point where a full-time QP becomes viable. Dual Contract QP cover can also be provided in conjunction with our affiliates at Vyvo BioSolutions. Depending on the scale of your operations, Contract QP cover generally requires a minimum of 2 days attendance on site each month, to ensure ongoing familiarity with your operations and Quality Assurance systems. (You can however contact us at any time via phone or email). To minimise associated travel costs, this service is particularly aimed at bio/pharmaceutical companies in Scotland / North of England. It generally takes 2 - 3 months from the initial MHRA application to obtain the appropriate licence variations to act as Contract QP. We can provide templates for the necessary contracts, Technical Agreements, and SOPs to ensure that the services are provided in full compliance with MHRA expectations. BioChem QP Consulting also carries its own public liability and professional indemnity insurance.
Contract QP Services Legal Batch Certification for your IMPs and Commercial products
Biologicals cell & viral banks, APIs, vaccines, ATMPs - gene therapies, cell therapies (including stem cells)
Small Molecules tablets, capsules, oral liquids, bottle / blister packing, lyophilised products, sterile injectables
External Links
QP Legislation / GMP Guidance: 2001/83/EC (commercial products) 2001/20/EC (IMPs) EU GMP Guide Annex 16 (QP Certification) Full EU GMP Guide:
BioChem QP Consulting Ltd. Registered Office 272 Bath Street, Glasgow G2 4JR Tel +44 (0)771 897 1245   email
MIA and MIA(IMP) licences
Experience with a wide range of product types, manufacturing processes, and dosage forms:
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