The Official Blog for Clifford Nilsen
Drug manufacturers need to have written procedures for everything they do
in the form of some official written document such as a Standard
Operating Procedure (SOP) or written test method.
All of these documents must have been reviewed and approved by the Quality
Control Unit, and most important, all written procedures must be
followed as written each and every time. Consistent execution of
written procedures is a key element of regulatory compliance. When
buying an OTC product or filling a prescription, you should not
have to worry about whether or not the drug manufacturer is
making your drug product the same way every time, and in line
with all regulations.
The burden of compliance rests with the drug manufacturer.
Whenever a fi rm asks FDA “how am I supposed to do this”, the
answer will always be “you’re supposed to know that”. Since
every company operates differently, individual drug company
operating procedures also vary widely, which is fi ne so long as
those procedures are effective in meeting regulatory requirements.
Drug companies must interpret how to meet FDA expectations of
compliance and therein lays the problem. These interpretations,
even when firms are conscientiously trying their best, do not
always hit the mark.
Drug companies carry a huge burden in their quest for
good compliance.
The Inspection Process:
Drug companies, when they first open their doors for business,
must register with the Food & Drug Administration (FDA ) as a drug establishment, after which
they are issued a registration number. The “Drug Establishment
Registrations” must be renewed annually.
There are several different types of registrations depending upon the nature of the drug establishment, i.e., manufacturer, packager, distributor or contract laboratory for example. Once a company has registered, they are on the FDA’s radar and put on the regulatory inspection
schedule.
By the way, anyone can start a drug company. Buy a bunch of manufacturing equipment cheap at auction (blenders, tablet
presses, packaging and lab equipment, etc), set up in a garage or basement, and start manufacturing, so long as the operation
is performed under a set of regulations know as Current Good Manufacturing Practices (cGMPs) conditions, which is unlikely for what we will call “Garage Pharmaceuticals”. The problem is that FDA probably won’t get around to inspecting this firm for about two years, after which they will more than likely be shut down. But wait a minute; what about the drug products that have been pushed into the market place over those two years? Are they safe and effective? Maybe, maybe not.
Unfortunately, there actually are some “Garage Pharmaceuticals” -type companies out there. Are you or your children using these drugs?—are they —maybe, maybe not. Is there any way to be sure?
When you purchase drug products, you don’t expect them to be contaminated with antifreeze, industrial chemicals, glass, or dangerous bacteria.
But this happens every day when uninformed consumers buy prescription or over-the- counter and behind-the-counter drug products. Armed with the right knowledge, you can avoid the dangers and risks of these drugs and protect yourself and your family.
This layperson’s guide, written by a drug industry insider, will tell you how the U.S. drug industry works, how drugs are made, where the ingredients come from, and how to identify which drug companies are good and which to avoid.
Imagine the horror as you rush your infant child to the hospital
emergency room. “Doctor, what’s wrong?” “We can’t be sure
miss, but it looks like some kind of poisoning”. After a short time,
the Doctor comes back out to tell the hysterical mother “I’m sorry,
but your baby died”.
What happened? Upon investigation, it was determined that the mother had given the baby a generic brand of infant ear drops for an ear ache. It turns out that the ear drops contained glycerin as a main ingredient, glycerin from China that was contaminated with anti-freeze.
How could that possibly happen? Well, this story is fictional, but glycerin from China contaminated with anti-freeze is real. How can we as consumers avoid buying contaminated or substandard drug products? Do you know if the products sitting in your medicine chest or kitchen cabinets are safe to use? How can you be sure?
This book uncovers and documents questionable drug industry practices and shows the reader how to avoid using potentially dangerous drug products
As a drug industry insider myself, if I told you what really goes on with U.S. drug manufacturing practices, you wouldn’t believe your ears.
Read my latest book, “Generic Drugs: A Consumer’s Self Defense Guide” You won’t believe your eyes.
Tablets, capsules, syrups, solutions, suspensions, creams and ointments; which ones are really safe?, and which ones could be hazardous?
Find out how to protect yourself and your family from potentially hazardous drug products, particularly over-the-counter drugs.
Did you know that many drug manufacturers use raw materials such as active ingredients that come from foreign countries whose product quality and manufacturing practices are suspect.
Do you want to use drug products that are contaminated with metal, glass, dangerous chemicals or harmful bacteria? Do you want to use drugs that are made in dirty equipment by untrained workers?
Get the facts: “Generic Drugs: A Consumer’s Self Defense Guide”
Generic drugs are cheaper, but you get what you pay for. When buying drug products, whether prescription or over the counter, your first concern should be safety and effectiveness. Many generic drugs are not equivalent to the brand name drug and even worse, could be potentially unsafe. Buyer beware!
Good news-Pfizer is trying to get OTC approval for Lipitor. Who the heck would want to take the generic?, soon to be available.
Many big drugs will be coming off patent over the next year or two. How can you be sure that the generic is safe, and are they worth the lower cost?
Russian Roulette should not be your game of choice when buying drug products ! Protect yourself and your family from the risks of buying potentially dangerous contaminated or toxic generic drug products with “Generic Drugs: A Consumer’s Self Defense Guide”, available from most book sellers in soft cover, hard cover and ebook, including Kindle version.
Click Here to Buy Generic Drugs: A Consumer’s Self-Defense Guide by Clifford Nilsen on iuniverse.com
Generic Drugs: A Consumer’s Self-Defense Guide 