1.3 Scope
This guidance applies to the manufacture of APIs for use in human
drug (medicinal) products. It applies to the manufacture of sterile
APIs only up to the point immediately prior to the APIs being
rendered sterile. The sterilization and aseptic processing of
sterile APIs are not covered by this guidance, but should be
performed in accordance with GMP guidances for drug (medicinal)
products as defined by local
authorities.
This guidance covers APIs that are manufactured by chemical
synthesis, extraction, cell culture/fermentation, recovery from
natural sources, or any combination of these processes. Specific
guidance for APIs manufactured by cell culture/fermentation is
described in Section
18.
This guidance excludes all vaccines, whole cells, whole blood and
plasma, blood and plasma derivatives (plasma fractionation), and
gene therapy APIs. However, it does include APIs that are produced
using blood or plasma as raw materials. Note that cell substrates
(mammalian, plant, insect or microbial cells, tissue or animal
sources including transgenic animals) and early process steps may
be subject to GMP but are not covered by this guidance. In
addition, the guidance does not apply to medical gases,
bulk-packaged drug (medicinal) products (e.g., tablets or capsules
in bulk containers), or
radiopharmaceuticals.
Section 19 contains guidance that only applies to the manufacture
of APIs used in the production of drug (medicinal) products
specifically for clinical trials (investigational medicinal
products).
An API starting material is a raw material, an intermediate, or an
API that is used in the production of an API and that is
incorporated as a significant structural fragment into the
structure of the API. An API starting material can be an article of
commerce, a material purchased from one or more suppliers under
contract or commercial agreement, or produced in-house. API
starting materials normally have defined chemical properties and
structure.
The company should designate and document the rationale for the
point at which production of the API begins. For synthetic
processes, this is known as the point at which API starting
materials are entered into the process. For other processes (e.g.,
fermentation, extraction, purification), this rationale should be
established on a case-by-case basis. Table 1 gives guidance on the
point at which the API starting material is normally introduced
into the
process.
From this point on, appropriate GMP as defined in this guidance
should be applied to these intermediate and/or API manufacturing
steps. This would include the validation of critical process steps
determined to impact the quality of the API. However, it should be
noted that the fact that a company chooses to validate a process
step does not necessarily define that steps as
critical.
The guidance in this document would normally be applied to the
steps shown in gray in Table 1. However, all steps shown may not be
completed. The stringency of GMP in API manufacturing should
increase as the process proceeds from early API steps to final
steps, purification, and packaging. Physical processing of APIs,
such as granulation, coating or physical manipulation of particle
size (e.g., milling, micronizing) should be conducted according to
this
guidance.
This GMP guidance does not apply to steps prior to the introduction
of the defined API starting
material.
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