Our May 2016 newsletter...a free publication from William Garvey and Associates, Lexington, MA. This month we discuss the 3-A Sanitary Standards, facility lighting and the start of the generic drug scandal.

1. Welcome to the third edition
of Since you asked...All about
GMPs and Validation. Our news-
letter is now being read across the
US and many international loca-
tions, including China, Brazil and
Ireland. We are currently review-
ing various distribution options as
our readership has grown.
This month we have focused on
the 3-A Sanitary Standards. These
standards were originally devel-
oped for the dairy industry, but
have direct application to both
pharmaceuticals and biotech.
You may be wondering why our
industry would utilize seemingly
unrelated guidelines. Here are
two reasons. Milk processing and
drug production have many com-
mon equipment counterparts.
Additionally, contaminated milk
and adulterated drugs are both
serious public health hazards
With continued success in the
important work we all do,
WELCOME FROM THE EDITOR
THIS MONTH’S FEATURED TOPIC - 3-A SANITARY STANDARDS
The 3-A Sanitary Standards were
introduced in the 1920’s through
the cooperation of three indepen-
dent interest groups. The purpose
of these standards was to promote
food safety and to improve dairy
equipment hygienic design and
sanitization.
The 3-A Sanitary Standards are
now consulted whenever drug
product contact equipment and
systems are designed and fabri-
cated. Why is this so important?
Consider this—like contaminated
drugs, contaminated milk is a haz-
ard to public health. Milk is widely
distributed, consumed in large
quantities in a short period of
time, and supports the growth of
pathogenic microorganisms. It is
used by the very young and those
already ill. In fact, FDA’s draft LVP
regulations of 1976 made specific
reference to 3-A requirements for
milk storage tanks because of sim-
ilarities to WFI holding tanks. For
information, refer to www.3-a.org.
SECTION 211.44 LIGHTING
GMP regulations provide minimal informa-
tion for lighting for drug production facilities.
Section 211.44 states: ”Adequate lighting shall
be provided in all areas.” So what is considered
adequate or acceptable lighting?
Lighting systems are commonly designed to
supply light intensity of 70 foot-candles at the
work surface. Lighting at aseptic filling lines and
similar critical areas deliver 100 foot-candles.
Warehouses and similar storage spaces only
require 50 foot-candles.
MORE ABOUT LIGHTING
Light intensity is tested during facility commis-
sioning and qualification. A calibrated intensity
meter is positioned at the work surface to con-
firm that lighting specifications are met. These
meters are widely available and inexpensive.
Since you asked...
All about GMPs and Validation
Volume 1
Issue 3
May 2016
Sterilizer with thermocouples inserted
Courtesy of Badger Meter
Since you asked...All about GMPs and Validation is
a publication of William Garvey and Associates.
Copyright © 2016 William Garvey and Associates

2. In 1987, Bolar Pharmaceutical
obtained FDA approval to market
a generic version of SmithKline’s
Dyazide, a popular combination
product intended for hyperten-
sion. Dyazide was very unique—it
was poorly bioavailable, and
therefore very difficult to copy.
SmithKline was stunned by Bolar’s
success, but in time took ap-
propriate investigative actions.
SmithKline obtained six different
lots of Bolar’s generic Dyazide and
submitted each lot to bioequiva-
lency testing. Surprisingly, all
six lots were inequivalent to the
brand name product.
SmithKline notified John Dingell’s
(D-MI) office who then informed
FDA. FDA investigated and
confirmed that Bolar had substi-
tuted Dyazide as its own product
for bioequivalency testing. The
generic drug scandal had now
begun, leading eventually to im-
proved inspections (PAI) and FDA’s
debarment list. To be continued.
GENERIC DRUGS - SUBSTITUTION, SCANDAL AND PAI
MICROSOFT EXCEL AND VARIABLE INPUTS
Microsoft Excel has many fea-
tures that are unknown or used
occasionally by the average
user. Two such technologies are
the Form and Active X controls
(Developer→Insert). Each set
of controls include a Scroll Bar
object that can be used to conve-
niently alter the input value to an
equation or even a graph.
Select the Form Scroll Bar and
place it anywhere on a worksheet.
Adjust its size by dragging the
handles, then click Properties on
the ribbon to modify the control.
The Format Control window will
now open. Select the Control tab.
Adjust any of the five parameters
provided. Select a cell to contain
the Scroll Bar’s output value. This
value becomes the input to an
equation or another object. Scroll
Bars are great for temperature
conversions and simulations.
William Garvey and Associates
Lexington, MA
williamgarvey@outlook.com
781.698.9215 www.wgarvey.com
Use Ctrl + ~ to
display all formulas
within a worksheet.
Very useful when
checking for errors.
William Garvey and Associates provides
validation and Quality-related services to the
regulated industries—pharmaceuticals, biologics
and medical devices.
Our services include protocol development
and execution, GMP and technical training, and
validation project management.
Follow us on Google+, Facebook or LinkedIn,
or on the web at www.wgarvey.com.
THE 3-A SYMBOL
The 3-A Symbol is a
registered mark used
to identify equipment
that meets 3-A Sanitary
Standards for design and
fabrication. In order to
use the 3-A Symbol on a
piece of equipment, the vendor must subject the
equipment to a Third Party Verification (TPV) by a
Certified Conformance Evaluator (CCE). This inde-
pendent inspection confirms that the equipment
meets the design requirements indicated in the
3-A Sanitary Standards. The next time you use a
common item such as a tri-clamp or sanitary pump,
look for the 3-A Symbol.
Fluidized Bed Dryer
The 3-A Symbol