Our April 2016 newsletter...a free publication from William Garvey and Associates, Lexington, MA. This month we discuss compressed air, the Waxman-Hatch Act, Word controls and charge-in of components.

1. Welcome to the second edition
of Since you asked...All about
GMPs and Validation. We are
pleased to report that our March
newsletter was very well received
and we hope to expand our read-
ership with each new edition we
publish.
This month we have focused on
compressed air (CA) systems.
Compressed air has multiple uses
in manufacturing facilities of all
types. However, there are special
requirements for drugs, devices
and biologics. These are dis-
cussed later in this publication.
A fact from the US Department of
Energy (DOE)...CA“leaks are a sig-
nificant source of wasted energy
in a compressed air system, often
wasting as much as 20%-30% of
the compressor’s output.” Iden-
tify and fix those leaks to reduce
system costs!
With continued success in the
important work we all do,
WELCOME FROM THE EDITOR
THIS MONTH’S FEATURED TOPIC - COMPRESSED AIR
There are two types of compressed
air systems operating in drug and
biotech facilities—instrument air
(IA) and clean compressed air
(CCA). These systems have signifi-
cant differences.
Instrument air is a motive force
commonly used to open valves
and HVAC dampers. IA makes no
product contact and consequent-
ly, has minimal quality require-
ments. These systems are oper-
ated at 110-125 PSIG and the air
has a dewpoint less than 35°F. IA
systems are usually not oil-free.
Clean compressed air makes direct
or indirect product contact. CCA
is used to dry wet equipment, for
sterilizer air-overpressure (AOP)
and to transfer liquids between
holding tanks. In 1976, FDA issued
draft regulations describing CCA
quality requirements. Since then,
common system design specifica-
tions are dewpoint less than -40°F
and oil/hydrocarbon content less
than 1 mg/m3.
COMPONENT CHARGE-IN
GMP regulations specifically state that a“batch
shall be formulated with the intent to pro-
vide not less than 100 percent of the labeled
or established amount of active ingredient.”
Although obvious, consider this example. USP
requires a tablet to contain active ± 10% of label
claim. A 100 mg tablet containing 90-110 mg
meets USP requirements. A well-controlled op-
eration produces tablets with 95 ± 5 mg active.
A manufacturer could charge-in 5% less active
ingredient and still comply with USP.
LABEL RECONCILIATION
When labeling operations are completed, label
reconciliation is required. Reconciliation helps
prevent product misbranding. If a discrepancy
occurs, immediately investigate. Did labels get
applied to the wrong drug product?
Since you asked...
All about GMPs and Validation
Volume 1
Issue 2
April 2016
Sterilizer Performance Qualification
Air-operated diaphragm valve
Since you asked...All about GMPs and Validation is
a publication of William Garvey and Associates.
Copyright © 2016 William Garvey and Associates

2. In 1984, Congress passed the
Drug Price Competition and Pat-
ent Term Restoration Act , better
known as the Waxman-Hatch
Amendments. This important leg-
islation was designed to increase
the availability of generic drugs. It
also created the abbreviated new
drug approval (ANDA) process.
One incentive to create a generic
was 180-day market exclusivity.
The first ANDA filed with FDA
challenging the brand name pat-
ent was entitled to 180-day exclu-
sivity after ANDA approval—no
other identical generic could be
sold.“First to market”essentially
assured large market share for life
of the product. The same benefit
applied to the first approved ge-
neric for an off-patent drug.
Given these financial incentives
and the outcome of“being sec-
ond or third,”many generic com-
panies decided to cheat. ANDA
data was falsified and FDA review-
ers were bribed...To be continued.
GENERIC DRUGS - ANDAs, EXCLUSIVITY AND CHEATING
MICROSOFT WORD AND PROTOCOL MANAGEMENT
It is estimated that Word users
only utilize about 15% of Word’s
features. Developer is an over-
looked ribbon tab containing con-
tent controls that expedite and
manage protocol development.
Validation protocols and reports
are QA documents that must be
consistently formatted and visu-
ally appealing. Individuals cannot
be allowed to revise boilerplate
text to suit personal preferences.
Problems often arise when ap-
proved protocols, not templates
are edited. Unless editing restric-
tions are imposed, protocols of-
ten drift away from the template.
Restrict Editing and Controls
are two useful features in Devel-
oper. Select template boilerplate
text and prevent revisions with
Restrict Editing. Controls limit
what variable information can be
added to a protocol or report.
William Garvey and Associates
Lexington, MA
williamgarvey@outlook.com
781.698.9215 www.wgarvey.com
Display Developer
by going to File/
Options/Customize
Ribbon, and then
select the Developer
checkbox.
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.
OIL IN COMPRESSED AIR
There are currently two
common ways to de-
termine oil content in
compressed air—Dräger
oil mist tubes and gas
chromatography (GC).
Dräger tubes are single-
use and inexpensive. GC
is rarely used, although
it is more accurate and
precise. Dräger testing or
GC sample collection is
performed at usepoints
far from the compressor.
Courtesy of Atlas Copco
Mixer/Granulator/Microwave Dryer