Lecture 4 - Quality Assurance and supply chains Flashcards
what is outsourcing?
Hiring an external contractor to perform an activity or service on your behalf. it is a Key activity of modern pharma and Involves third party companies: those you have no control over.
what kind of functions do Pharma companies outsource?
Legal, IT, building
Specialised testing, operations
Raw material/product production
‘Virtual companies’ must outsource
what are the pros of outsourcing?
cost reduction, specialised skills, buy temporary resource or skills, shorter timeframes, global activity
what are cons of outsourcing?
costs with unexpected issues
tech transfer can be complex
problems ‘fall down the gap’
cultural issue s
remote site = lack of control/accountability
mutual ‘cross-blame’
intellectual property
explain the role of a contact giver in outsourced activities.
contact giver is the organisation outsourcing part of their good practice guidelines operations to an external party
they should give the contract acceptor all suitable knowledge to perform operations and review the performance of the contract acceptor. they retain responsibility for ensuring that the product of outsourcing is correct and fir for purpose
explain the role of a contact acceptor in outsourced activities.
contact acceptor is The company that receives the contract from the Contract Giver to carry out specific services or operations.
CA’s are not allowed to subcontract work onwards or change processes without approval. Its important that the outsourcing company knows that they are operating to GMP and so can be inspectable
They often hold GxP licences of their own: ie they are inspected and approved.
what is the contract ?
the contract is often called a technical agreement.
The Contract should describe clearly who undertakes each step of the outsourced activity, e.g. knowledge management, technology transfer, supply chain, subcontracting, quality and purchasing of materials, testing and releasing materials, undertaking production and quality controls
it also outlines Who (CG or CA) does what, where, when?
Who tells who when it goes wrong? (CG, CA, Comp. Authority)
what are the different MHRA licenses?
Marketing Authorisation/Product Licences (PL); if you want to sell a medicinal product
Manufacturing licences; if you want to manufacture a medicinal product
Wholesale licences,
Parallel import licence, Brokers licence; if you want to be involved in there supply chain you need to prove that you can operate in that distribution chain in a way that make sure ALL the product stay ‘fit for purpose
‘specials’ license; if you want to manufacture a medicinal product
Registration of homeopathic medicines and Traditional Herbal Registration medicines THR
describe the amrletign authorisation of a medicinal product.
medicines are licensed by the marketing authorisation. Granted based upon quality, safety and efficacy
The licence for a medicine includes information such as: indications, dose, formulation, safety issues (side effects and contra-indications), storage and stability information
MA needs PL. The PL number is the long code (starting with PL) on packets of pharmaecuticals or the patient information leaflet
what are the different types of manufacturers licenses?
Manufacturer/ importer licence: Manufacture and/or assemble licensed medicinal products, including export to a country outside theEEA
Manufacturer ‘specials’ licence; Manufacture unlicensed medicines ‘specials’
Manufacturer licence for IMP:Manufacture investigational medicinal products for use in clinical trials
Manufacturer licence exempt ATMP: Manufacture exempt ‘advanced therapy medicinal products’ on a non-routine basis for use in UK hospitals
what does a specials license involve?
Defined as ‘Specials’ are products which have been specially manufactured or imported for the treatment of an individual patient after being ordered by a prescriber where prescribing being in the best interest of a patient
The manufacturer must hold a Manufacturer’s “Specials” licence and the site and its operations will be inspected for compliance with Good Manufacturing Practice (GMP).
needs a quality management service, needs production and quality control managers. does not need qualified person to be released.
describe the MHRA liecene for brokers and parallel imports.
Brokers registration: act as intermediaries in the supply chain (don’t pay for, own or physically handle the product).
Parallel import licence: Import the ‘same ‘ product to the UK from the EU
Simple: ‘common origin’ and ‘the same’
Standard: ‘not simple or complex’
Complex: products that require more attention.
