Dear readers,
we are willing to certify a medical device (MD) composed of substances as a Class III ,since one of the substances will be considered ancillary. The other ones, are part of the MD (have a physical MoA)
Our questions are:
- we think that the ancillary substance should be produced and controlled under GMP conditions. Thus, we should be certified as "gmp-compliant or another gmp-compliant company should produce the medicinal susbtance. Is this right?
-But, Is the fact that this GMP-substance is present means that the whole product (the non-pharmacological substances) should also be analysed under GMP?
we have read that the FDA allows you to show compliance with a QS system (CFR 820) and then apply some specifics requirements related with the drug gmp (CFR 211). However, we do not know which requirements apply to the EU...
many thanks in advance!
MLM
we are willing to certify a medical device (MD) composed of substances as a Class III ,since one of the substances will be considered ancillary. The other ones, are part of the MD (have a physical MoA)
Our questions are:
- we think that the ancillary substance should be produced and controlled under GMP conditions. Thus, we should be certified as "gmp-compliant or another gmp-compliant company should produce the medicinal susbtance. Is this right?
-But, Is the fact that this GMP-substance is present means that the whole product (the non-pharmacological substances) should also be analysed under GMP?
we have read that the FDA allows you to show compliance with a QS system (CFR 820) and then apply some specifics requirements related with the drug gmp (CFR 211). However, we do not know which requirements apply to the EU...
many thanks in advance!
MLM