Pharmaceuticals - Fundamentals of Industrial Chemistry: Pharmaceuticals, Polymers, and Business - page 167

In 2012, the Food and Drug Administration Safety and Innovation Act
(FDASIA), was signed into law. It expands the FDA's authorities and
strengthens the agency's ability. FDASIA gave the FDA a new expedited
drug development tool, known as the "breakthrough therapy" designation.
The purpose is to expedite the development and review of new drugs
with preliminary clinical evidence that indicates the drug may offer a
substantial improvement over available therapies for patients with serious or
life-threatening diseases.
One way that the FDA protects public health is to make sure that pharma-
ceuticals are made by good manufacturing practices (GMP). Because this is
not static, but is expected to continuously improve, the regulations call for
current good manufacturing practices (cGMP). The goal is to protect public
health, but the concept is to build quality into the products with the idea that
products manufactured by cGMP are safe, properly identified, and of high
quality.
There are many aspects of cGMP. They include elements such as organiza-
tion, documentation, training, corrective actions, raw material qualification,
and equipment validation. The organization should have a quality assurance
unit responsible for approving or rejecting procedures or specifications, com-
pliance with procedures, and approval or rejection of manufactured product.
The organization must have adequate staffing; they must be trained, and the
training documented. Equipment must be calibrated and validated. Approved
written procedures for production and process controls must be maintained
and any deviations properly documented. Production and laboratory records,
equipment cleaning logs, and distribution records must be maintained for at
least one year after the expiration date of the drug.
Standard Operating Procedures (SOPs) are critical to cGMP compliance.
To convince you of this, think about paper airplanes. Everyone thinks they
know how to make a paper airplane. It is something we all did in our child-
hood. However, ask 10 people to make and fly a paper airplane and you will
witness 10 varied flights. Some will travel less than a foot; others may soar
more than 50 feet. This huge variation is not acceptable in drug manufacture.
Imagine if there were a 50-fold variation in purity or potency. Detailed SOPs
must be followed to ensure product quality and uniformity. There must be
enough detail to make sure that different shifts or different people all make
the same product. The details may seem like overkill and it can be tedious
to read or write these procedures, but the consequences of a minor change
influencing the quality of the product make it absolutely necessary to follow
SOPs. Any changes from SOPs must go through a change control process.
Documentation of the change control is critical.
When equipment is installed, it has to be qualified to ensure that it has
been properly installed and operational qualification performed to make sure