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FDA Takes First Step in Recognizing the Role of Emerging Technologies
in the Area of Process Validation
Effective March 12, 2004, FDA revised a long-standing policy
document regarding the validation of pharmaceutical manufacturing
processes for drugs that are subject to pre-market approval
requirements. This policy guide is now titled
Process Validation
Requirements for Drug Products and Active Pharmaceutical Ingredients
Subject to Pre-Market Approval (formerly titled Process
Validation Requirements for Drug Products Subject to Pre-Market
Approval). Compliance Policy Guides (CPG) are intended for
agency staff and are for the purpose of consolidating agency
compliance policy decisions.
As with the previous version of this policy guide, the new
version reaffirms that agency drug product pre-market review units
may approve applications for marketing before a firm has
manufactured one or more conformance batches at commercial scale
(also sometimes referred to as "validation" batches). The
revised CPG again recognizes certain conditions under which a firm
may market batches of drugs while gathering data to confirm the
validity of the manufacturing process.
New to this version is the recognition of the role of emerging
advanced engineering principles and control technologies in ensuring
batch quality. For drugs produced using these new principles and
technologies, this CPG provides for possible exceptions to the need
for manufacturing multiple conformance batches prior to initial
marketing. This version also deletes the previous reference to
"three" validation (or conformance) batches at commercial
scale as adequate minimum proof of process validity — a number is no
longer suggested. Also, this version further clarifies the
importance of post-market information gathering especially for those
batches released to market concurrent with the manufacture of the
initial conformance batches. And, finally, this version adds a
reference to the currently recognized standard for CGMPs in the
manufacture of active pharmaceutical ingredients: Guidance for
Industry, Q7A, GMP Guidance for Active Pharmaceutical Ingredients,
issued August 2001.
This is an important first step in the Agency’s plan to address
the area of process validation. The next step will be to update the Guideline
of General Principles of Process Validation (May
1987), to
reflect modern manufacturing principles, technology, and science.
This update will be revised in accordance with the agency's Good
Guidance Practice procedures and include public notice and comment
before being finalized. The final step of this process will be
addressing the proposed revisions of the CGMPs, the Federal
Register dated May
3,1996, Current Good Manufacturing Practice; Proposed Amendment
of Certain requirements for Finished Pharmaceuticals. This
effort is being taken in concert with FDA’s initiative on the
regulation of pharmaceutical quality known as "Pharmaceutical
cGMPs for the 21st Century: A Risk-Based Approach."
Progress on these issues will be included in future announcements on
the initiative.
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Date created: March 17, 2004 |
