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
Eligibility
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 enquiries@biochem-qp.com
MIA and MIA(IMP) licences
Experience with a wide range of
product types, manufacturing
processes, and dosage forms:
