Professional Documents
Culture Documents
Agenda
Introduction What are the GMPs?
Pre-GMP Historyy ((<1963))
GMP History (1963-2007)
Making GMP History (2007-Present)
Conclusion
2
http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=613
5
Those
Those who cannot remember the past
are condemned to repeat it.
G
George
Santayana
S t
W
We live
li iin a reactive,
ti
nott proactive,
ti
society
Reactive Government
FEMA 1802; assistance to NH town after a fire
FTC 1914; anti-trust & monopolies; Black
Tuesday
OSHA 1971; coal mining and other disasters
USDHS 09/11/2001
FCC Janet Jacksons 2004 wardrobe
malfunction
FDA todays discussion
10
12
1905 The
The Great American Fraud
Fraud
11-part patent medicine
series in Colliers
Collier s
Exposed quackery,
nostrums, & ephemera
False claims by mfrs.
Raised real health
concerns
Lack of quality control
Many contained alcohol,
addictive drugs, or worse!
Led to public outrage and
g
p
pressure on
significant
Congress
13
Patent Medicines
N d a Little
Need
Littl PickPick
Pi k-meme-Up?
U ?
Carry
Carry this package with you always
always
http://theodoregray.com/PeriodicTable/PopularScience/2004/08/2/image3.jpg
14
1906 The
The Jungle
Jungle by Upton Sinclair
Corruption of US meat packing industry
Attempting to promote socialism over capitalism,
but became best-seller
best seller (to Sinclairs
Sinclair s lament)
"not because the public cared anything about the
workers, but simply because the public did not want to
eat tubercular beef
15
The
The Jungle,
Jungle , Chapter 14 (Excerpts)
Jonas had told them how the meat that was taken out
of pickle would often be found sour
sour, and how they
would rub it up with soda to take away the smell, and
sell it to be eaten on free-lunch counters
There was never the least attention p
paid to what was
cut up for sausage; there would come all the way back
from Europe old sausage that had been rejected, and
that
h was moldy
ld and
d white
hi it
i would
ld b
be d
dosed
d with
ih
borax and glycerine, and dumped into the hoppers, and
made over again for home consumption
consumption
16
The
The Jungle,
Jungle , Chapter 14 (Excerpts)
There would be meat that had tumbled out on the floor, in the dirt
and sawdust, where the workers had tramped
p and spit
p uncounted
billions of consumption germs. There would be meat stored in
great piles in rooms; and the water from leaky roofs would drip
over it, and thousands of rats would race about on it. It was too
dark in these storage places to see well, but a man could run his
hand over these piles of meat and sweep off handfuls of the dried
dung of rats.
rats These rats were nuisances,
nuisances and the packers would
put poisoned bread out for them; they would die, and then rats,
bread, and meat would go into the hoppers together. This is no
f i story
fairy
t
and
d no joke;
j k th
the meatt would
ld b
be shoveled
h
l d iinto
t carts,
t and
d
the man who did the shoveling would not trouble to lift out a rat
even when he saw one there were things that went into the
sausage in comparison with which a poisoned rat was a tidbit
17
1933: America
Americas
s Chamber of Horrors
FDA exhibited real products to pressure fixing the
1906 laws flaws, including:
A weight
g loss drug
g that caused death
A hair remover that caused baldness, even if not used
on the head
An eyelash dye that blinded women (next slide)
Lotions & creams that caused mercury poisoning
First
Fi t Lady
L d El
Eleanor R
Roosevelt
lt ttook
k thi
this exhibit
hibit tto th
the
White House and appealed to America's women to
campaign for stronger protections for consumers
20
1933: America
Americas
s Chamber of Horrors
Lash Lure the
the
New and improved
Eye Brow and Eye
L hD
Lash
Dye
H
However, iit took
k
another tragedy to
change the law
law
http://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118458.htm
21
22
FDA's
FDA s investigation revealed plant control
deficiencies and irregularities
In both production & recall processes
R
Result:
lt FDA d
drastically
ti ll revises
i
rules
l on
manufacturing & quality controls
Hailed as the birth of GMPs,, though
g GMP
regulations wont be issued for 23 more years
25
26
27
29
For manufacturing,
g
processing, packing or
holding finished
pharmaceuticals
pharmaceuticals
30
Subpart G (122-137)
Packaging and Labeling
Control
Subpart H (142-150)
Holding
H ldi and
d Di
Distribution
t ib ti
Subpart I (160-176)
Laboratory Controls
S b t J (180
Subpart
(180-198)
198)
Records and Reports
Subpart K (204-208)
Returned
R t
d and
d Salvaged
S l
dD
Drug
Products
34
1980: FDAMA
1980 Food & Drug Administration
Modernization Act (FDAMA)
Congress
g
required
q
FDA to "make p
public a p
plan that
establishes a framework for achieving mutual
recognition of good manufacturing practices
inspections
inspections
Also: prior to this, GMPs were not required for Overthe-Counter (OTC) products
OTC products on the market now required testing
Products with a safe history were given time to comply
37
211.221
211 221 would
ld d
define
fi requirements
i
t ffor method
th d validation
lid ti
211.240 would define requirements for control of physical
& chemical contaminants
Proposal later (2007) shelved complete paradigm shift
In light of more recent scientific and technical advances and evolving
quality
lit systems
t
and
d risk
i k managementt concepts.
t
39
41
43
1341
14.1%
634
6.7%
594
6 2%
6.2%
4 Documentation - manufacturing
526
5.5%
463
4.9%
432
4.5%
371
3.9%
8 Environmental monitoring
323
3 4%
3.4%
9 Process validation
317
3.3%
297
3.1%
5298
52.5%
# of inspections:
# of GMP deficiencies overall
45
423
9465
45
47
48
Paul A. Melamud
Validation Manager
QPharma Inc.
22 South Street
Morristown, NJ 07960
paul.melamud@qpharmacorp.com
(973) 462-0653
49