Public procurement notice: Contract Notice
Published: 2020-06-03
Buyer: Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Country: UK
Contract type: Supplies
Procedure: Negotiated procedure
CPV classification: 24000000 | 24950000 | 33000000 | 33100000 | 33140000: Medical consumables
Estimated value:  GBP
Submission deadline: 2020-06-30
Award criteria: The most economic tender

Technical requirements: Nuclear, biological, chemical and radiological protection equipment, medical specialist services, pharmaceutical products, pharmaceutical articles, medical equipments, pharmaceuticals and personal care products, miscellaneous medical devices and products, medical consumables, chemical products, specialised chemical products, medical equipments, medical needles. The UK Ministry of Defence (UK MOD) has an identified and likely future requirement for the production of single and triple therapy auto-injector devices for intramuscular administration. The auto-injectors should be capable of storing up to three active pharmaceuticals ingredients in a single, dual or triple chambered device. Full operating capability will require the final drug product to be submitted to Regulatory Agencies in the EU and the United Kingdom with the intent for full licensure/marketing authorisation (MA). The chemical biological radiological nuclear team (CBRN) is therefore seeking to appoint a partner to manufacture current auto-injector requirements with future options to manufacture other similar devices as they arise throughout the contractual period.
1) demonstrating of wet or wet/dry storage capability in an existing auto-injector. The maximum capacities of chamber will be no more than 3 ml or 1.5 ml per chamber if dual chamber;
2) protocols for, and results of, forced degradation studies of Midazolam, atropine and 2PAM, using previously validated analytical methods demonstrated to qualify and quantify known degradants of each API;
3) documentation of the processes and validated test methods describing the manufacturing and performance of the active auto-injector/drug product;
4) demonstration of stability of active auto-injectors, and of the active pharmaceutical ingredients stored within the active auto-injector;
5) demonstration of wet storage capability in an auto-injector i.e. within the cartridge or the device. The maximum capacities of the chamber will be no more than 3 ml, or 1.5 ml if dual chamber (and sufficient if dual chamber for separated API;
6) demonstration of technical and performance (including safety). Testing described in ISO 11608 and the quality systems of ISO13485 and the requirements of the Medical Devices Regulations (MDR) should be considered. Distribution robustness should be modelled and tested to ensure the product remains intact under operational transport stresses;
7) demonstration of robustness (stress testing) of the tertiary packaging of the assembled auto-injector in its proposed tertiary packaging, and suitability of the packaging for military use;
8) provision of the specification documentation for the active auto-injector device, the APIs and the processes and test methods describing the manufacturing and performance of the active auto-injector device;
9) demonstration of the consistency of manufacturing of the active auto-injector device through process validation activities according to ICH Q8 R2 Part 1;
11) protocols for, and results (in interim and final Reports) of ICH and GxP-compliant stability studies. Stability studies for up to 5 years;
12) certification of the auto-injector to CE standard, meeting the requirements of the Medical Device Regulation 2017/745, as amended, and manufactured to ISO 13485:2016 (or current version);
13) documentation and data review to populate a common technical document prior to marketing authorisation application, including a paediatric investigation plan waiver;
14) manufacture product in accordance with current good manufacturing practice (cGMP) standards as defined by the International Conference on Harmonisation and regulated by the national competent Authority’s in Europe and Canada;
15) storage of the finished product and all product movement between qualified person (QP) release and receipt will be carried out in accordance with the requirements of good distribution practice (GDP) and the guidelines on GDP on medicinal products for human use (2013/C 343/01) or as subsequently amended.

Eligibility requirements: (c) where appropriate, a statement, covering the 3 previous financial years of the economic operator, of: (i) the overall turnover of the business of the economic operator; and (ii) where appropriate, the turnover in respect of the work, works, goods or services which are of a similar type to the subject matter of the contract. This will be detailed in the ITN.
This will be detailed in the ITN.
This will be detailed in the ITN. This will be detailed in the ITN.