WORKING IN A
REGULATED ENVIRONMENT
– ARE YOUR
BIOTECH STUDENTS
PREPARED?
Bio-Link Summer Fellows Forum 2013
Vivian Ngan-Winward, PhD, CMQ/OE
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1
THIS WORKSHOP COVERS . . .
 Overview of a regulated environment
 Basics of FDA regulations
 How biotech companies comply
 Common FDA inspection observations
 How to prepare students for
 Working in a regulated environment
 Making contributions toward compliance
2
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BIOTECHNOLOGY
INDUSTRY
OVERVIEW
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3
BIOTECH PRODUCT LIFE CYCLE
Idea
Research &
Development
[‘Proof of
Concept’]
Prototyping
/ Pilot Plant
[Validation &
Smaller
Scale
Production]
Manufacturing
[Mass / Large
Scale
Production]
Consumer
Business strategy :
 Develop for manufacturability
 Initiate compliance efforts at the idea stage
(identify market)
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4
MARKETING PRODUCTS
 Requires FDA approval / clearance
 Pre-clinical & clinical trials
 Submit application
 Include data to support :
o Product claims
o Product safety
 Approval / clearance given by appropriate
FDA center with oversight for product type
5
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WHY THE NEED FOR
REGULATIONS ?
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6
. . . LESSONS FROM THE PAST
1800’s
Misbranding (e.g. labeling is false or misleading) :
food, “tonics”, “elixirs of life”
1906
Poor meat-packing conditions →
Upton Sinclair’s The Jungle
Federal Food and Drug Act →
first regulation of product labeling
1927
USDA Bureau of Chemistry →
Food, Drug, and Insecticide Administration (to FDA in 1930)
1937
Sulfanilamide elixir disaster : 107 deaths !!!
1938
Federal Food, Drug, & Cosmetic (FD&C) Act
1960
Application for Kevadon denied (Frances Kelsey);
thalidomide disaster in Europe (1961-1962)
7
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. . . LESSONS FROM THE PAST
(CONT.)
1962
FD&C Act Kefauver-Harris Amendments
1971
Dalkon Shield disaster
1976
FD&C Act Medical Device Amendments
1970’s
- now
GXPs
 GMP for Blood & Blood components –
21 CFR 606 (1975)
 GMP for Drugs - 21 CFR 210 & 211 (1978)
 GLP – 21 CFR 58 (1978) for pre-clinical studies
 GMP for Food – 21 CFR 110 (1986)
 GMP for Medical Devices [QSR] – 21 CFR 820 (1996)
 GMP for Dietary Supplements – 21 CFR 111 (2007)
8
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A CLOSER LOOK –
FD&C ACT (1938)
 Extended control to cosmetics and therapeutic devices
 Required new drugs to be shown safe before marketing
 Eliminated Sherley Amendment requirement (to prove
intent to defraud in drug misbranding cases)
 Provided for safe tolerances be set for unavoidable
poisonous substances
 Authorized standards of identity, quality, and fill-ofcontainer for foods
 Authorized factory inspections
 Added of court injunctions to the penalties
9
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A CLOSER LOOK –
KEFAUVER-HARRIS AMD. (1962)
 Required manufacturers to provide evidence that
proposed drugs were both safe and effective,
demonstrated by adequate and well-controlled clinical
investigations conducted by qualified experts
 Required FDA evaluation of new drug applications (180
days); applications would no longer become
automatically effective
 Required affirmative FDA decision of new drugs before
marketing
 Required manufacturers to maintain records of adverse
drug events and to report these promptly to FDA
10
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BENEFITS OF REGULATIONS
 Sets standards for manufacturers and
expectations for their products
 Protects the public: some assurance of
safety and efficacy
11
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REGULATIONS REFERENCES
 FDA : What We Do : History
http://www.fda.gov/AboutFDA/WhatWe
Do/History/default.htm
 Sinclair (1906) The Jungle
12
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STUDENT PREPARATION IDEAS
 Discussion on an aspect of regulations
history
 Research / presentation on one of the
product “disasters”
Goal: orientation to the history and
importance of regulations
13
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THE LAWS &
CODE OF FEDERAL
REGULATIONS
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14
LAWS → REGULATIONS
US Federal Government
FDA
United States Code
(U.S.C.) – Title 21
Laws
Codified
Promulgated in
Federal Register
Code of Federal Regulations
(CFRs) – Title 21, Food & Drugs
15
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FD&C ACT OVERVIEW









Chapter I: Short Title
Chapter II: Definitions
Chapter III: Prohibited Acts and Penalties
Chapter IV: Food
Chapter V: Drugs and Devices
Chapter VI: Cosmetics
Chapter VII: General Authority
Chapter VIII: Imports and Exports
Chapter IX: Miscellaneous
16
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FD&C ACT OVERVIEW (CONT.)
FD&C Act / U.S.C. section number crossreference
http://www.fda.gov/RegulatoryInformation
/Legislation/FederalFoodDrugandCosmeti
cActFDCAct/default.htm
17
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21 CFR OVERVIEW
Parts
Covers
100 series
Food – 110 cGMPs ; Dietary supplements – 111 cGMPs
200 & 300 series
Pharmaceuticals – 210 & 211 cGMPs
500 series
Animal feeds & medications
600 series
Biological products – 606 cGMPs
700 series
Cosmetics (limited regulations)
800 series
Medical devices – 820 cGMPs
900 series
Mammography quality requirements
1000 series
Radiation emitting device
1200 series
Non-FD&C Act rulings
Other
GLP – 58; GCP – 50, 54, 56; Electronic Records – 11
18
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21 CFR ?
21 CFR Parts can be viewed at
http://www.ecfr.gov
19
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STUDENT PREPARATION IDEAS
 Select several 21 CFR Parts and assign
one to each student to summarize and
present to the class
 Assign students to select and report
on one 21 CFR Part of interest
Goal: exposure to 21 CFRs, and how to
find them
20
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FOOD AND DRUG
ADMINISTRATION
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21
FDA OVERVIEW
 An agency of Department of Health and
Human Services (as of 1979)
 Mission:
1. “ responsible for protecting the public
health by assuring the safety, efficacy, and
security of human and veterinary drugs,
biological products, medical devices, our
nation’s food supply, cosmetics, and
products that emit radiation ”
22
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FDA OVERVIEW (CONT.)
 Mission
(cont.):
2. “ responsible for advancing the public
health by helping to speed innovations that
make medicines and foods more effective,
safer, and more affordable; and helping the
public get the accurate, science-based
information they need to use medicines
and foods to improve their health ”
23
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FDA ORGANIZATION
From: www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/default.htm
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24
FDA ORGANIZATION (CONT.)
FDA Subdivisions:
Subdivision
Responsibility
Office of the Commissioner
Program administration
Office of Regulatory Affairs
Enforces FDA regulations, monitors industry
for compliance, recalls
Center for
Biologics
Evaluation &
Research
(CBER)
Assorted biological products/biologics (these
replicate natural human substances):
allergenic extracts for shots, blood & blood
components, gene therapy products,
transplant-related human tissue and cellular
products, vaccines
25
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FDA ORGANIZATION (CONT. 2)
FDA Subdivisions (continued):
Subdivision
Responsibility
Center for
Drug
Evaluation &
Research
(CDER)
Drugs (purely chemical substances),
therapeutic biological products (e.g.
monoclonal Abs, cytokines, growth factors,
enzymes, thrombolytics, proteins [natural or
recombinant]) extracted from animals for
therapeutic use, non-vaccine therapeutic
immunotherapies
Center for
Devices &
Radiological
Health
(CDRH)
Medical devices (e.g. catheters, breast
pumps, contact lenses, lab instrumentation),
diagnostic test kits, GMP, compliance,
postmarket tracking, radiological health
screening procedures (mammography, whole
body CT scanning, medical imaging)
26
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FDA ORGANIZATION (CONT. 3)
FDA Subdivisions (continued):
Subdivision
Responsibility
Center for
Food Safety &
Applied Nutrition
(CFSAN)
Various food products, GMOs, cosmetics,
dietary supplements, infant formula,
foodborne illness, food labeling & nutrition
Center for
Veterinary Medicine
(CVM)
Food additives and drugs given to animals;
animals from which human foods are derived
27
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BIOTECH PRODUCT JURISDICTION
Product Type
FDA Center
Vaccine and blood product type therapeutic proteins
CBER
Some therapeutic biological products (mAbs for in vivo
use, therapeutic proteins, cytokines and growth factors
used as immunomodulators or alterers of cell
production)
Transferred
to CDER
Combination products (e.g. drug/device,
biologic/device, drug/biologic, drug/device/biologic) –
combined, packaged together, packaged separately but
to be used together
CBER, CDER,
or CDRH,
depends on
primary mode
of action
Genetic tests for disease diagnosis or disease
prevention, treatment, or cure
CDRH
Biosimilars (generic biologic, not identical to original)
CDER
28
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REGULATED PRODUCT APPROVALS
Drugs
Application Type
Purpose
Investigational New
Drug (IND)
To request exemption of approved marketing
application for shipping new drug across state
lines for clinical trials
New Drug
Application (NDA)
To request approval to sell and market new drug
in US; submitted with supporting documentation
detailing drug ingredients; how drug is
manufactured, processed, and packaged; results
of animal studies and clinical studies; how the
drug behaves in the body
Abbreviated New
Drug Application
(ANDA)
To request approval to sell and market generic
drug in US; application need not include animal
and clinical studies, but must show evidence that
generic is bioequivalent to innovator drug
29
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REGULATED PRODUCT APPROVALS
(CONT.)
Drugs . . . 2
Application Type
Purpose
Over-the-Counter
Drug (OTC)
Not an application; manufacturer can sell and
market an OTC drug with FDA pre-approval if it
conforms to the FDA-published OTC monograph;
one monograph for each of 80 therapeutic
classes of OTC drugs; monograph contains
acceptable ingredients, doses, formulation, and
labeling, and defines safety and effectiveness
Biologic License
Application (BLA)
To request approval to sell and market biologic
in US; like a NDA but for a biologic
30
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REGULATED PRODUCT APPROVALS
(CONT. 2)
Medical Devices
Application Type
Purpose
Investigational
Device Exemption
(IDE)
To request exemption of approved marketing
application for shipping investigational device
across state lines for clinical trials; clinical trials
typically required to support premarket approvals,
but occasionally needed to support premarket
notifications
Premarket
Notification (PMN) /
510(k) Clearance
To request clearance to sell and market in US nonexempt Class I device or Class II device that is
substantially equivalent to a legally marketed
(predicate) device
Premarket Approval
(PMA)
To request approval to sell and market non-preamendment Class III or non-510(k) device in US
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31
REGULATED PRODUCT APPROVALS
(CONT. 3)
Medical Devices . . . 2
Application Type
Purpose
Humanitarian
Device Exemption
(HDE)
To request exemption of certain requirements to
sell and market humanitarian use device (HUD) in
US that is intended to benefit patients through
treatment or diagnosis of disease or condition
affecting < 4,000 individuals per year; like a PMA
but exempt from proof of effectiveness
requirement
32
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REGULATED PRODUCT APPROVALS
(CONT. 4)
Medical Device Notes
 Device classification:
o Depends on intended use and indications for use
o Over 1,700 distinct devices, grouped into 16
medical specialty panels [per 21 CFR 862-892],
have been classified
o 3 classes: Class I, Class II, and Class III, with
regulatory control increasing from I to III – see:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
Overview/GeneralandSpecialControls/default.htm
33
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REGULATED PRODUCT APPROVALS
(CONT. 5)
Medical Device Notes
(cont.)
Device
Class
Definition
Class I
• Low risk
• Most (~74%) are exempt; non-exempt require PMN / 510(k)
• Exempt manufacturers must still register establishment
and list generic category or classification name
• Exempt devices not exempt from GMP requirements;
however, some are GMP exempt but not from records and
complaint files
• Some exempt devices have limitations to exemption status
• Subject to general controls
34
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REGULATED PRODUCT APPROVALS
(CONT. 6)
Medical Device Notes
Device
Class
Class II
Class III
(cont. 2)
Definition
•
•
•
•
Moderate risk
Most are not exempt and usually require PMN / 510(k)
Some are exempt, but not from GMP requirements
Subject to general controls, and special controls to assure
safety and effectiveness
• High risk - pose significant risk of illness or injury (devices
usually support or sustain human life); OR
not substantially equivalent to Class I or Class II predicate
• Not exempt and require PMA unless a pre-amendment
(pre May 28, 1976) device
• Subject to general controls with PMA
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35
REGULATED PRODUCT APPROVALS
(CONT. 7)
Medical Device Notes (cont. 3)
 Substantial equivalence: if, in comparison
to predicate . . .
o Has same intended use AND technological
characteristics
o Has same intended use BUT different
technological characteristics that are supported
by data that (1) shows device is at least as safe
and effective as predicate AND (2) does not
raise new safety and effectiveness questions
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36
FDA WEB SITE RESOURCES
 Center–specific information for industry






AND consumers
About FDA
Regulatory info & guidance documents
Science & research
News
Recalls & alerts
Approvals & clearances
37
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STUDENT PREPARATION IDEAS
 Invite a local biotech company
representative to speak to your class
about the process required to achieve
a recent product approval / clearance
 Examine and discuss an application for
a recently approved / cleared product
Goal: exposure to FDA submissions
38
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GOOD
? PRACTICES
(GXPS)
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39
WHAT ARE GXPS ?
GXPs = “best” practices
& FDA mandated
 defines what compliance requires
 does not describe exactly how to do it
40
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21 CFR OVERVIEW
Parts
Covers
100 series
Food – 110 cGMPs ; Dietary supplements – 111 cGMPs
200 & 300 series
Pharmaceuticals – 210 & 211 cGMPs
500 series
Animal feeds & medications
600 series
Biological products – 606 cGMPs
700 series
Cosmetics (limited regulations)
800 series
Medical devices – 820 cGMPs
900 series
Mammography quality requirements
1000 series
Radiation emitting device
1200 series
Non-FD&C Act rulings
Other
GLP – 58; GCP – 50, 54, 56; Electronic Records – 11
41
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DIFFERENT GXPS
 Good clinical practices (GCP) :
 Regulates clinical trials involving human
subjects
 Protects human rights
 Provides assurance of safety and efficacy of
developed product
 Good laboratory practices (GLP) :
 Regulates nonclinical laboratory studies that
support FDA approval applications
 Good manufacturing practices (cGMP) :
 Regulates manufacture of products covered by
FD&C Act
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42
GOOD MANUFACTURING
PRACTICES (GMP)
 Most stringently described in 21 CFR Parts
 110 : for food
 111 : for dietary supplements
 210 & 211 : for drugs
 606 : for biologics
 820 : for medical devices (QSRs)
 Provides detailed requirements on how to
operate manufacturing business
 Indirectly impacts R&D
43
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GMP DESIGN CONTROLS
 Design Inputs & Outputs
 Design Verification : Outputs = Inputs
 Design Validation
 Compilation of records:
 Design History File (DHF) : describes design
history of finished product
 Device Master Record (DMR) : contains
procedures and specifications of finished
device/product (“recipe”)
 Device History Record (DHR) : contains
production history of device/product
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44
GMP EXAMPLE
 Medical device cGMP
up close . . .
See also : FDA’s CDRH Learn – Quality
System Regulation 21 CFR 820 Basic
Introduction presentation
http://www.fda.gov/MedicalDevices/ResourcesforYou
/Industry/ucm126252.htm
45
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GXP REFERENCES
 GLP:
o 21 CFR 58
o Lab Compliance GLP tutorial
http://www.labcompliance.com/tutorial/gl
p/default.aspx?sm=d_a
o WHO GLP Handbook (2009)
http://www.who.int/tdr/publications/traini
ng-guideline-publications/good-laboratorypractice-handbook-ver1/en/
46
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GXP REFERENCES (CONT.)
 GMP FDA guidance documents:
o http://www.fda.gov/Drugs/GuidanceComplian
ceRegulatoryInformation/Guidances/ucm06497
1.htm
o http://www.fda.gov/BiologicsBloodVaccines/G
uidanceComplianceRegulatoryInformation/Gui
dances/General/ucm217665.htm
o http://www.fda.gov/MedicalDevices/DeviceRe
gulationandGuidance/PostmarketRequirements
/QualitySystemsRegulations/MedicalDeviceQua
litySystemsManual/default.htm
47
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STUDENT PREPARATION IDEAS
 GXP comparison activity:
Align these 21 CFR Parts:
o GLP (21 CFR 58)
o drug cGMP (21 CFR 210 & 211)
o biologics cGMP (21 CFR 606)
o medical device cGMP (21 CFR 820)
Goal: exposure to details of GXPs and how
they are similar / different
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48
REGULATORY
COMPLIANCE
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49




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FDA
Laws (U.S.C.)
Industry-Specific CFRs
GMPs
QSRs
Non-gov’t Org
Regulations (CFRs) - gov’t
agency promulgated
Good Manufacturing
Practices (GMPs)
Quality System Regulations
(QSRs)
Standards / Certifications
(e.g. ISO)
Quality Management System
Industry
 the FDA [regulating body]
 the Laws [US Code]
 the Code of Federal
Company
A tight relationship exists
between
Government
THE HIERARCHY
ISO
Standards
/ Certif.
(e.g. ISO)
Quality Management System
50
COMPLYING WITH FDA REGS
How ?
51
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“INTERPRETING REGULATIONS”
What does the sign mean to you ?
How will you ensure compliance ?
52
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COMPLYING WITH FDA REGS . . . 2
By appropriately
interpreting the
regulations
53
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COMPLYING WITH FDA REGS . . . 3
A quality management
system provides a
structure for
the company to
work within and
remain compliant
54
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QUALITY
MANAGEMENT
SYSTEM
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55
QUALITY MANAGEMENT SYSTEM
(QMS) – CHARACTERISTICS
 Required by the FDA (not optional !)
 “Each manufacturer shall establish and
maintain a quality system that is
appropriate for the specific medical
device(s) designed or manufactured, and
that meets the requirements of this part.”
– 21 CFR 820.5
 Designed by each company to align its
operations with the regulations
56
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WHAT IS A QMS ?
 Per 21 CFR 820.3 – “the organizational
structure, responsibilities, procedures,
processes, and resources for implementing
quality management”
 Per Wikipedia – “a set of policies,
processes, and procedures required for
planning and execution of production in
the core business area of an organization”
57
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WHAT IS A QMS ? (CONT.)
 Has a customer focus
 Often designed to meet ISO 9001 standards
– based on 8 principles:
1.
2.
3.
4.
5.
6.
7.
8.
Customer focus
Leadership
Workforce involvement
Continuous improvement
System approach to management
Data-based approach to decision making
Positive supplier communication / relationships
Total process approach
58
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WHAT IS A QMS ? (CONT. 2)
 Main components
 Management responsibility
 Resource management
 Product realization
 Measurement, analysis, and improvement
 Process-oriented approach to managing
quality
 A framework that directs quality
contributions from all employees
59
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QMS PROCESS MODEL
Quality Management System
Continual Improvement
C
U
S
T
O
M
E
R
R
e
q
u
i
r
e
m
e
n
t
s
Management
Responsibility
Measurement,
Analysis, &
Improvement
Resource
Management
input
Process /
Product
Realization
output
S
a
t
i
s
f
a
c
t
i
o
n
C
U
S
T
O
M
E
R
Product /
Service
60
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WHAT DOES THE QMS COVER ?
 Training & qualifying personnel
 Controlling product design
 Controlling documentation & records
 Controlling purchasing
 Identifying & tracing product at all production
stages
 Defining & controlling production & processes
 Defining & controlling inspection / measuring /
test equipment
61
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WHAT DOES THE QMS COVER ?
(CONT.)
 Validating processes
 Accepting product
 Controlling nonconforming product
 Instituting corrective & preventive actions
 Controlling labeling & packaging
 Servicing production equipment
 Using statistical techniques
62
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COMMON FDA OBSERVATIONS
 Catalogued by the FDA on an annual basis
 Access through:
http://www.fda.gov/ICECI/EnforcementAc
tions/ucm250720.htm
 Examples from FDA inspections during
fiscal year 2012 (Oct 1, 2011 to Sep 30,
2012) – actual observations reported on
Form 483’s
63
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DRUG OBSERVATIONS . . . 1
Observation
The responsibilities and procedures applicable
to the quality control unit are not [in writing]
[fully followed]. Specifically, ***
There is a failure to thoroughly review [any
unexplained discrepancy] [the failure of a
batch or any of its components to meet any of
its specifications] whether or not the batch has
been already distributed. Specifically, ***
There are no written procedures for production
and process controls designed to assure that
the drug products have the identity, strength,
quality, and purity they purport or are
represented to possess. Specifically, ***
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Freq
Reg Ref
169
21 CFR
211.22(d)
119
21 CFR
211.192
116
21 CFR
211.100(a)
DRUG OBSERVATIONS . . . 2
Observation
Laboratory controls do not include the
establishment of scientifically sound and
appropriate [specifications] [standards]
[sampling plans] [test procedures] designed to
assure that [components] [drug product
containers] [closures] [in-process materials]
[labeling] [drug products] conform to
appropriate standards of identity, strength,
quality and purity. Specifically, ***
Control procedures are not established which
[monitor the output] [validate the
performance] of those manufacturing processes
that may be responsible for causing variability
in the characteristics of in-process material
and the drug product. Specifically, ***
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Freq
Reg Ref
115
21 CFR
211.160(b)
89
21 CFR
211.110(a)
DRUG OBSERVATIONS . . . 3
Observation
Written procedures are not [established]
[followed] for the cleaning and maintenance of
equipment, including utensils, used in the
manufacture, processing, packing or holding of
a drug product. Specifically, ***
Routine [calibration] [inspection] [checking] of
[automatic] [mechanical] [electronic]
equipment is not performed according to a
written program designed to assure proper
performance. Specifically, ***
Employees are not given training in [the
particular operations they perform as part of
their function] [current good manufacturing
practices] [written procedures required by
current good manufacturing practice
© 2013 Vivid Ngenuity, LLC.
All rights reserved.***
regulations].
Specifically,
Freq
Reg Ref
73
21 CFR
211.67(b)
69
21 CFR
211.68(a)
65
21 CFR
211.25(a)
DRUG OBSERVATIONS . . . 4
Observation
Equipment and utensils are not [cleaned]
[maintained] [sanitized] at appropriate
intervals to prevent [malfunctions]
[contamination] that would alter the safety,
identity, strength, quality or purity of the drug
product. Specifically, ***
Written production and process control
procedures are not [followed in the execution
of production and process control functions]
[documented at the time of performance].
Specifically, ***
© 2013 Vivid Ngenuity, LLC. All rights reserved.
Freq
Reg Ref
65
21 CFR
211.67(a)
64
21 CFR
211.100(b)
DRUG OBSERVATIONS . . . 5
Observation
Testing and release of drug product for
distribution do not include appropriate
laboratory determination of satisfactory
conformance to the [final specifications]
[identity and strength of each active
ingredient] prior to release. Specifically, ***
© 2013 Vivid Ngenuity, LLC. All rights reserved.
Freq
Reg Ref
62
21 CFR
211.165(a)
DEVICE OBSERVATIONS . . . 1
Observation
Procedures for corrective and preventive
action have not been [adequately] established.
Specifically, ***
Procedures for receiving, reviewing, and
evaluating complaints by a formally designated
unit have not been [adequately] established.
Specifically,***
Written MDR procedures have not been
[developed] [maintained] [implemented].
Specifically, ***
Procedures to ensure that all purchased or
otherwise received product and services
conform to specified requirements have not
been [adequately] established. Specifically, ***
© 2013 Vivid Ngenuity, LLC. All rights reserved.
Freq
Reg Ref
372
21 CFR
820.100(a)
259
21 CFR
820.198(a)
140
21 CFR
803.17
126
21 CFR
820.50
DEVICE OBSERVATIONS . . . 2
Observation
Corrective and preventive action activities
and/or results have not been [adequately]
documented. Specifically, ***
Procedures have not been [adequately]
established to control product that does not
conform to specified requirements.
Specifically, ***
A process whose results cannot be fully verified
by subsequent inspection and test has not been
[adequately] validated according to
established procedures. Specifically, ***
Procedures for design change have not been
[adequately] established. Specifically,***
© 2013 Vivid Ngenuity, LLC. All rights reserved.
Freq
Reg Ref
115
21 CFR
820.100(b)
110
21 CFR
820.90(a)
102
21 CFR
820.75(a)
101
21 CFR
820.30(i)
DEVICE OBSERVATIONS . . . 3
Observation
Complaints involving the possible failure of [a
device] [labeling] [packaging] to meet any of
its specifications were not [reviewed]
[evaluated] [investigated] where necessary.
Specifically, ***
Procedures for quality audits have not been
[adequately] established. Specifically, ***
A device master record has not been
[adequately] maintained. Specifically, ***
© 2013 Vivid Ngenuity, LLC. All rights reserved.
Freq
96
91
91
Reg Ref
21 CFR
820.198(c)
21 CFR
820.22
21 CFR
820.181
COMMONALITY
 Procedures for XXX not [adequately]
established / followed
© 2013 Vivid Ngenuity, LLC. All rights reserved.
STUDENT PREPARATION IDEAS
 Review and discuss these common
observations with students
 Case studies – select Form 483’s for class
review and discussion (RE: local
companies have more relevance)
http://www.fda.gov/AboutFDA/CentersOffices/Offi
ceofGlobalRegulatoryOperationsandPolicy/ORA/ORA
ElectronicReadingRoom/default.htm
Goal: understand common mistakes to
better contribute toward compliance
© 2013 Vivid Ngenuity, LLC. All rights reserved.
73
QUESTIONS ?
Vivian Ngan-Winward
vivian.ngan-winward@slcc.edu
801-957-6210
74
© 2013 Vivid Ngenuity, LLC. All rights reserved.