Emil W. Ciurczak
Emil W. Ciurczak has worked in
the pharmaceutical industry since
1970 for companies that include Ciba-Geigy,
Sandoz, Berlex, Merck, and Purdue Pharma,
where he specialized in performing method development on most types of analytical equipment. In 1983, he introduced NIR spectroscopy
to pharmaceutical applications, and is generally
credited as one of the first to use process analytical technologies (PAT) in drug manufacturing
What are GMPs?
And why do we need them in contract work?
Current Good Manufacturing Practices (cGMPs) are, in short, at the heart of every move we make in pharmaceuticals. Quite literally, every step from simple
notebook record keeping through final release of the product is overseen by GMPs.
Since the majority of people in the industry do not remember a time without them,
much as millennials can’t grasp a world
without smart phones or cable TV, we tend
to assume they’ve always been in force. In
fact, GMPs are relatively new.
So, from my perspective, the updated,
comprehensive edition of 1978, cGMPs
only became an issue eight years after I
became a full-time worker in the industry. As I am wont to point out that, by the
time we were told by the U.S. FDA how to
properly conduct research, we had already
walked on the moon, had color TVs, were
routinely using polio vaccines, penicillin,
streptomycin, had performed organ transplants, and were using computers. As you
might imagine, a number of older scientists considered them intrusive.
But are they all that bad? Well, much
as a razor blade: are you getting a clean
shave or a nasty nick on the chin. cGMPs
are based on the initial contract of the
FDA with industry: make the product safe
and effective. Sounds straightforward, no?
However, consider another set of“simple”
rules: The Ten Commandments. You would
think that “don’t steal” or “don’t murder”
would be self-explanatory, wouldn’t you?
Nonetheless, we have tens of thousands
of priests, rabbis, mullahs, and ministers
making a living, telling us what these
“simple” words mean.
Likewise, the simple command,
“Make the product safe and effective,”
has spawned tens of thousands of SOPS,
guidances, guidelines, consent decrees,
observations, and such. Never mind that
we have a massive bureaucracy centered
around Washington, DC to“help” us un-
derstand what “good” means. Please,
do not misunderstand. Had our “dis-
tinguished” industry not killed so many
people, there wouldn’t have been a need
for the FDA. (Fun fact: the initial Pure Food &
Drug Act only specified that commercial phar-
maceuticals could not hurt people. Only a later
edition of the Act suggested that the product
should also work as advertised.)
So many of cGMPs are logical, posting
them makes as much sense as telling food
handlers to wash their hands after using
the restroom: 1. Permanent notebooks
must be kept in pen, with an index; cross-
outs must be a single line with an expla-
nation of why an entry was changed; all
pages should be dated and witnessed; no
pages may be left blank, etc. All things we
learned in freshman science class; 2. No
cross-contamination; 3. Proper venting
must be utilized; and 4. Labels must con-
tain proper (pre-approved) information.
However, there are useful rules that
are not always taught in beginning
classes. These are important, but restrictive, so companies do them grudgingly.
1. Stability studies: a) downside: time-consuming and personnel-intensive;
b) important: critical for many drugs,
since some degradation products
could be toxic; c) mixed review: some
drugs can last longer than the sun
and stability tests with outdating as
a formality, costing money passed on
to the patient.
2. Activity vs. toxicity: a) necessary: the
mode of action and dosage size is critical to know and any potential toxicity
needs to be documented; b) overkill:
every chemical has an LD50 (a“lethal
dose” level, where 50% of test subjects
die), even table salt and tap water. So,