Therefore, it is important for supply chain management to reduce the probability of receiving RMs that fail to meet specifications.
This is part of the payoff of a robust and sustainable vendor and RM qualification program. In establishing an RM qualification program, first determine your internal business requirements.
is interpreted to mean the specific ability or capacity of the product, as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through the administration of the product in the manner intended, to effect a given result.
Both the chemical entity and suppliers must be qualified, usually in tandem.
An RM qualification and control program is considered a key factor in assuring the quality of medicinal drugs, yet it is often deemed of secondary importance at a busy firm.
Usually, RM testing is not considered scientifically challenging or exciting - until, of course, the supply chain is imperiled by a single failure.
26, 1990; 61 FR 24232, May 14, 1996; 62 FR 39901, July 24, 1997; 64 FR 56449, Oct. It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly.
Quality assurance for finished pharmaceuticals, biopharmaceuticals, medical devices, and active pharmaceutical ingredients (APIs) includes the specification and control of those components that have product contact during manufacturing, that is, the raw materials (RMs).
Considering the rapid rate of change to these regulations, sustaining a compliant, effective program requires a strategic approach.