Pharmacy contracts with manufacturer

[ilyas ali]

Dear All,

If I am a sponsor and I would like to outsource the production of IMP as I do not have the facility to manufacture the IMP. Do I need to have any sort of agreement with manufacturer? If yes then what kind of points should be included.
All comments will be appreciated.

Many thanks

[davidhan]

For me, before you research this area, you need to find some additional information such as:
eDIS allows people attending pharmaceutical contract adjudication meetings to make disclosures of any interests which could be viewed as affecting that persons impartiality in the meeting decision.


Pharmex holds data on 13 million line order entries for over 10,000 products.


CMU request for stockholding is a tool used by pharmaceutical suppliers to upload data on their stock levels which is then used to supply accurate volumes to suppliers for tendering.


Bravo is used by pharmaceutical buyers and suppliers and the CMU to manage tendering activity and contract negotiations.

[CQAO_GEN]

Dear ilyas,
it's mandatory to have contratual agreement with IMP manufacturer additionnaly it would be recommanded to have Quality Agreement (QtA) with the IMP manufacturer (define responsabilities regarding IMP management and certification by the Qualified person regarding GMP_annex 13 for IMP). You should also request a GMP certificate (or accessible online on the european database). Please note that regarding GMP_annex 13 it's the sponsor responsability to release IMP for use but also validate any batch recall.
hope this helps
best regards

[tommyleaton]

Dear ilyas Ali,
In my opinion, The pharmaceutical market uses outsourcing services from providers in the form of contract research organizations (CROs) and contract manufacturing
organizations (CMOS).

By CMU registered pharmaceutical suppliers regarding their business continuity plans.