IVTGXP_JULY07.
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The Main Differences Between
Chinese GMP and the International
GMP ICH Q7
By Xudong Xie, Ph.D.
ABSTRACT
Appreciation of
In this paper, a brief introduc-
the distinctions tion of Chinese GMP with respect
between the to legislation, guidelines, and the
GMP certification system is given.
Chinese GMP and This is followed by a comprehen-
the International sive comparison of Chinese GMP
with international GMP ICH Q7,
GMP helps covering the main aspects of
GMP starting point, product
companies
quality management, personnel,
entering the buildings and facilities, materials
management, production
Chinese market management, validation as
to better under- well as documentation. The
characteristics of Chinese
stand Chinese GMP with respect to methods,
regulations and procedures, operations, and
documentation for the manufac-
to secure their ture of pharmaceutical products
place in that are especially emphasized.
market.
INTRODUCTION
The implementation of good
manufacturing practice (GMP) is
an effective measure for assuring
the quality, safety, and effective-
ness of pharmaceutical products.
With the rapid development of
Chinas economy, GMP has
30 Journal of GXP Compliance
become more and more impor-
tant for Chinese pharmaceutical
companies, especially for those
that want to export their products
to the world market. Awareness
of the differences between the
Chinese GMP and the interna-
tional GMP would be helpful
both for Chinese companies to
manufacture their products meet-
ing international GMP require-
ments, and for foreign companies
entering the Chinese market to
better know the characteristics of
Chinese GMP and consequently
to assure product quality when
materials sourcing.
In the last decade, new legis-
lation, regulations, and guidelines
governing the manufacture of
pharmaceutical products have
been promulgated in China,
e.g., Drug Administration Law
of China (2001),1 Regulations
for Implementation of the Drug
Administration Law of China
(2002),2 Good Manufacturing
Practice for Pharmaceutical
Products (1998),3 Criteria for the
GMP Certification and Inspection
(2006)4 as well as the Guide for
IVTGXP_JULY07.qxd 6/18/07 11:39 AM Page 31
Figure 1
Criteria for the GMP Certification and Inspection*
Deficiencies Found During Inspection
Number of Critical Percentage of
Items Non-Critical Items
0 20%
0 21 - 40%
3 20%
0 > 40%
3 > 20%
>3
the Validation of Drug Production (2003).5
The current Chinese GMP Good Manufacturing
Practice for Pharmaceutical Products was amended
and issued as regulation by the State Foods and
Drugs Administration (SFDA) of China in 1998.3
Based on the former 1992 version, it includes 14
chapters and 88 articles, covering organization and
personnel, building and facilities, equipment, mate-
rials, hygiene and sanitation, validation, documen-
tation, production management, quality manage-
ment, production distribution and recall, complaints
and adverse reactions report, and self-inspections.
In addition, it encompasses six appendices, which
are supplementary provisions for the aseptic
drugs, non-aseptic drugs, active pharmaceutical
ingredients (APIs), biological product, and radioac-
tive products, as well as Chinese medicine.
The SFDA requires all pharmaceutical compa-
nies to gain GMP certification for the production of
pharmaceuticals (e.g., APIs, finished products).
Otherwise, they will not receive the allowance
(permission) to continue manufacturing pharma-
ceuticals. The deadline for gaining GMP certifica-
tion was June of 2004. Criteria for GMP Certifica-
tion and Inspection was issued in draft form by the
SFDA in 2006 based on Chinese GMP regulation.4
There are 268 inspection items in this criteria in
total, including 115 critical items and 153 non-criti-
cal items. Chinese GMP certification is based on
assessment of on-site inspection results (see
Figure 1). Such GMP certification is valid for five
Xudong Xie, Ph.D.
Results
Qualified for the GMP certification
Corrective actions should be taken within
6 months and inspection will be done again
Not qualified for the GMP certification
* SOURCE: CRITERIA FOR THE GMP CERTIFICATION AND INSPECTION 4
years. After the validity period has transpired, a full
inspection will be conducted by SFDA to check
whether the drugs manufacture still meets the
GMP requirements.
In order to guide the Chinese pharmaceutical
companies to carry out validation activities, a
Guide for the Validation of Drug Production was
published by SFDA in 2003 in Chinese6, which was
written by experts from various major Chinese
pharmaceutical companies. This book focuses
mainly on theories, methods, and procedures as
well as examples of validation, including six chap-
ters: basic concepts and general principles of vali-
dation, validation of buildings and facilities, valida-
tion of analytical methods and cleaning validation,
validation of dosage production, APIs, and comput-
erised systems. However, it should be stressed
that this book is only a technical reference book for
the validation of drug production and is not legally
required by the SFDA.
This article focuses mainly on the comparison of
Chinese GMP and ICH Q7 Good Manufacturing
Practice Guide for Active Pharmaceutical Ingredi-
ents (APIs),6 covering mainly the aspects of GMP
starting point, personnel, quality management, build-
ings and facilities, materials management, produc-
tion management, validation, and documentation.
J u l y 2 0 0 7 Vo l u m e 11 , N u m b e r 4 31
IVTGXP_JULY07.qxd 6/18/07 11:39 AM Page 32
Xudong Xie, Ph.D.
COMPARISON OF CHINESE
GMP AND ICH Q7
Scope and GMP starting point
ICH Q7 applies only to the manufacture of APIs
for use in human drug (medicinal) products (see
1.3). In comparison, Chinese GMP is applicable to
the manufacture of both finished products and
active pharmaceutical ingredients (APIs) (see Article
2). However, it should be mentioned that the ICH
Q7 incorporated into the EU GMP EU Guidelines
to Good Manufacturing Practice Medicinal Products
for Human and Veterinary Use extends the scope of
application to animal drug products.7
In the ICH Q7 guideline, an API starting material
is defined as:
a raw material, intermediate, or an API
that is used in the production of an API
and is incorporated as a significant
structural fragment into the structure of
the API. API starting materials normally
have defined chemical properties and
structure.
The guideline requires also that:
the company should designate and
document the rationale for the point at
which production of the API begins and
from this point on, appropriate GMP as
defined in this guide should be applied
to these intermediate and/or API manu-
facturing steps. (See 1.3.)
In Chinese GMP, a definition of starting material
and GMP starting point is not given. The only
requirement prescribed in the supplementary provi-
sion for the APIs production and quality control (i.e.,
the annex for APIs) is that the batch production
records of APIs should be started at the latest from
the refinement of crude product, which could be
similar to the GMP starting point.
According to the ICH Q7: less stringent in-
process controls may be appropriate in early pro-
cessing steps, whereas tighter controls may be
appropriate for later processing steps (e.g., isolation
and purification steps) (see 8.31). In comparison,
32 Journal of GXP Compliance
Chinese GMP focuses mainly on the last production
process steps from the crystallization, which are
required to be executed in cleanrooms (see the
annex for APIs).8
Personnel
The ICH Q7 requires that there should be an
adequate number of personnel qualified by appro-
priate education, training, and/or experience to per-
form and supervise the production of intermediates
and APIs (see 3.1).
In Chinese GMP, there are more detailed
requirements on the education of the responsible
persons of company management, production
management, and quality management. Those
persons should have at a minimum a college
degree of medicine, pharmaceuticals, or related
sciences. The responsible persons of the quality
management department and the production man-
agement department should be independent of
each other (see Articles 4 and 5). Training for per-
sonnel engaged in production and quality control of
drugs is needed according to Chinese GMP, but
there is no requirement on the periodical assess-
ment of the effectiveness of training, although
training examination is required (see Article 7).
Concerning the personnel hygiene, Chinese
GMP requires additionally that health files of drug
production personnel be established. For production
personnel with direct contact with drugs, a physical
examination should be conducted at least annually
(see Article 56). Generally, Chinese GMP focuses
more on personnel hygiene in cleanrooms.
Quality Management
According to ICH Q7, there should be an effective
system for managing quality which should encom-
pass the organizational structure, procedures,
processes, and resources, and necessary activities
to ensure that products will meet the intended speci-
fications for quality and purity. For this purpose, the
responsibilities of the quality unit and responsibility
for the production activities are specified, and inter-
nal audits and product quality reviews are required.
Moreover, in this quality management system, the
quality unit (QU) must be independent from the pro-
duction unit, fulfilling both quality assurance (QA)
and quality control (QC) responsibilities (see 2.1).
IVTGXP_JULY07.qxd 6/18/07 11:39 AM Page 33
Figure 2
Comparison of Responsibilities of Quality Unit and Quality Management Department
Quality Unit - ICH Q7
Releasing or rejecting all APIs. Releasing
or rejecting intermediates for use outside
the control of the manufacturing company
Reviewing completed batch production and
laboratory control records of critical process
steps before release of the API for distribu-
tion
Establishing a system to release or reject
raw materials, intermediates, packaging,
and labeling materials
Approving intermediate and API contract
manufacturers
Approving all specifications and master pro-
duction instructions
Ensuring that materials are appropriately
tested and the results are reported
Ensuring that there is stability data to sup-
port retest or expiry dates and storage con-
ditions on APIs and/or intermediates where
appropriate
Ensuring that critical deviations are investi-
gated and resolved
Approving all procedures impacting the
quality of intermediates or APIs
Approving changes that potentially impact
intermediate or API quality
Reviewing and approving validation proto-
cols and reports
Ensuring that internal audits (self-inspec-
tions) are performed
Ensuring that quality related complaints are
investigated and resolved
Ensuring that effective systems are used
for maintaining and calibrating critical
equipment
Performing product quality review
Xudong Xie, Ph.D.
Quality Management Department
Chinese GMP
Reviewing batch production records and
deciding on the release of final products
Deciding on the use of materials and inter-
mediates
Evaluating the quality systems of critical
material suppliers together with other related
departments
Establishing in-house specifications and ana-
lytical procedures of materials, intermediates,
and finished products, including sampling
and sample retention procedures
Sampling, testing, retaining samples of mate-
rials, intermediates, and finished products
and issuing analytical reports
Evaluating the stability of raw materials, inter-
mediates, and finished products, and provid-
ing data for determining the storage period of
materials and the expiration date of the drug
Reviewing the treatment procedure of
rejected products
Monitoring the particulates and microorgan-
isms in the cleanrooms (areas)
Establishing the procedures for controlling
testing equipment, instrument, reagent, test-
ing solution, standard substance (or refer-
ence substance), titration solution, culture
medium, experiment animals, etc.
Establishing the responsibilities of the per-
sons engaged in quality management and
quality test
J u l y 2 0 0 7 Vo l u m e 11 , N u m b e r 4 33
IVTGXP_JULY07.qxd 6/18/07 11:39 AM Page 34
Xudong Xie, Ph.D.
In Chinese GMP, there is a quality management
department which is responsible for quality control
and testing of drugs. The quality management
department should be led directly by the responsible
management of the company. The responsible per-
sons of the quality management department and the
production management department should be
independent of each other (see Articles 5 and 74).
In general, the quality management department of
Chinese GMP has limited responsibilities in compar-
ison with the ICH Q7, focusing mainly on the activi-
ties related to product quality testing or analysis
(see Figure 2).
A comparison of the responsibilities of the quality
unit of ICH Q7 and the responsibilities of the quality
management department of the Chinese GMP are
shown in Figure 2 (see ICH 2.2 and Chinese
GMP Article 75).
According to ICH Q7, a product quality review to
verify the consistency of process should be annually
conducted and adequate corrective action should be
taken. Such reviews focus on at least (see 2.5):
Critical in-process control and critical test
results
All batches that failed to meet established
specifications
All critical deviations or non-conformances
and related investigations
Figure 3
The Classification of Cleanrooms Chinese GMP*
Grade of Air Maximal Permitted Number of
Cleanliness Particles /m3
0.5 m 5 m
100 3,500
10,000 350,000
100,000 3,500,000
300,000 10,500,000
34 Journal of GXP Compliance
Any changes carried out to the processes or
analytical methods
Results of the stability monitoring program
All quality-related returns, complaints and
recalls
Adequacy of corrective actions
In comparison, a similar requirement such
as product quality review cannot be found in the
Chinese GMP.
Buildings and Facilities
According to Chinese GMP, pharmaceutical com-
panies should be located in a clean environment,
e.g., the location or site with less industrial pollution.
The general layout of the production, administration,
living, and ancillary areas should be appropriately
arranged. Whether buildings are appropriately
located in accordance with the production process
flow and the required air cleanliness classes, is con-
sidered to be one of the critical items during the
SFDAs on-site inspection for GMP certification
(see Articles 8 and 9). In comparison, similar
requirements are not described in ICH Q7.
In Chinese GMP, it is not certain whether defined
areas or other control systems for all the following
activities required by ICH Q7 are to be considered
during the design and construction of buildings and
facilities (see 4.14):
Maximal Permitted Number of
Microorganisms
Air Sample Settle Plates
(cfu/m3) (cfu/plate)
0 5 1
2,000 100 3
20,000 500 10
60,000 - 15
* SOURCE: THE ANNEX OF THE CHINESE GMP GENERAL PRINCIPLE9
IVTGXP_JULY07.qxd 6/18/07 11:39 AM Page 35
Receipt, identification, sampling, and quaran-
tine of incoming materials, pending, release or
rejection
Quarantine before release or rejection of inter-
mediates and APIs
Sampling of intermediates and APIs
Holding rejected materials before further dispo-
sition (e.g., return, reprocessing or destruction)
Storage of released materials
Production operations
Packaging and labeling operations
Laboratory operations
There are adequate requirements for cleanrooms
in Chinese GMP. However, for the classification of
air cleanliness grade, there are differences between
Chinese GMP and international GMP (see Figure 3
and Figure 4). For example, the air cleanliness class
of 300,000 in Chinese GMP is an unknown class for
foreign countries.
According to Chinese GMP, the last production
steps of APIs (e.g., refinements, drying, and packag-
ing) should be conducted in cleanrooms of not lower
than class 300,000. For APIs with legal microbiologi-
cal control requirements, they should be processed in
cleanrooms of class 10,000 (even in class 100 if nec-
essary) (see annex for APIs).8 In comparison, require-
ments of such kind are not described in ICH Q7.
Figure 4
The Classification of Cleanrooms EU GMP*
Grade of Air Maximal Permitted Number of
Cleanliness Particles /m3
0.5 m 5 m
A 3,500
B 3,500
C 350,000
D 3,500,000 20,000
* SOURCE: THE ANNEX 1 OF THE EU GUIDELINES TO GMP MANUFACTURE OF STERILE MEDICINAL PRODUCTS7
Xudong Xie, Ph.D.
Material Management
According to Chinese GMP, the management
systems for purchase, storage, dispatching, and use,
etc., of materials used for production should be
established (see Article 38). However, there is no
explicit requirement on the following activities, e.g.
(see ICH Q7, Section 7):
Changing the source of supply of critical raw
materials should be treated according to
change control
Materials stored in fiber drums, bags, or
boxes should be stored off the floor and suit-
ably spaced to permit cleaning and inspection
Sampling should be conducted at defined
locations
Materials should be re-evaluated to deter-
mine their suitability for use
Full analysis should be conducted on at least
three batches before reducing in-house testing
Production Management
In Chinese GMP there are mainly four kinds of
production management documents, e.g., master
formula, job position instruction, standard operating
procedure (SOP), and batch production records
(see Article 62). The operational requirements for
process and in-process control are only mentioned
in the master formula and batch production records
without detailed contents. The following contents
Recommended Limits for
Microbial Contamination
Air Sample Settle Plates
(cfu/m3) (diam. 90mm, cfu/4h)
1 <1 <1
1 10 5
2,000 100 50
200 100
J u l y 2 0 0 7 Vo l u m e 11 , N u m b e r 4 35
IVTGXP_JULY07.qxd 6/18/07 11:39 AM Page 36
Xudong Xie, Ph.D.
required by ICH Q7 are not mentioned in those doc-
uments (see Section 8):
Critical activities (e.g., critical weighing, mea-
suring, subdividing operations) should be wit-
nessed or subjected to an equivalent control.
Any deviation should be documented and
explained. Any critical deviation should be
investigated.
If time limits are specified in the master pro-
duction instruction, these time limits should
be met to ensure the quality of intermediates
and APIs. Deviations should be documented
and evaluated.
In-process controls and their acceptance cri-
teria should be defined based on the informa-
tion gained during the development stage or
historical data or todays risk analysis.
Critical in-process controls, including control
points and methods, should be stated in writ-
ing and approved by the quality unit.
In-process sampling should be conducted
using procedures designed to prevent contam-
ination of the sampled material and other prod-
ucts. Procedures should be established to
ensure the integrity of samples after collection.
Blending is defined as the process of combin-
ing materials within the same specification to
produce a homogeneous product. Acceptable
blending operations include mainly:
Blending of small batches to increase
batch size
Blending of tailings from batches of the
same product to form a single batch
In ICH Q7, there are clear definitions and
requirements to guide rejection, reprocessing,
reworking, and recovery during the drugs production
(see Section 14). However, requirements on such
activities are not prescribed in Chinese GMP. More-
over, operational procedures for deviation, change
control, and out-of-specification (OOS) required by
ICH Q7 (see 6.53, 11.15, and Section 13) are also
absent in Chinese GMP.
36 Journal of GXP Compliance
Validation
Nowadays, risk analysis is highly recommended
during the validation of drug production even if not
directly outlined within the international GMP (ICH,
U.S., EU). Before starting validation, a comprehen-
sive risk analysis is conducted to define the APIs in
terms of critical product attributes, to identify
process parameters that could affect the critical
quality attributes of the APIs, and to determine the
range for each critical process parameter expected
to be used during routine manufacturing and
process control. However, there is no such recom-
mendation on risk analysis or equivalent measures
for validation in Chinese GMP.
In Chinese GMP, the requirements on validation
are very briefly described, including mainly the qual-
ification (IQ/OQ/PQ) of buildings, facilities and
equipment, validation of production process, change
control, revalidation, as well as documentation (see
Chapter 7). However, there is no detailed require-
ment on the contents of those validation activities.
Moreover, design qualification (DQ), cleaning valida-
tion, validation of analytical methods, and validation
of computerised systems are not officially mentioned
in Chinese GMP, although those validation activities
are described in the SFDAs technical book Guide
for the Validation of Drug Production 6.
Chinese GMP stipulates that revalidation should
be conducted at defined intervals or after any signifi-
cant changes that may affect the product quality,
e.g., changes of production process, quality control
method, critical raw material and excipient, and criti-
cal equipment (see Article 58). But it should be
stressed that detailed requirements on change con-
trol procedures cannot be found in Chinese GMP. A
full revalidation is also required by Chinese GMP
when the GMP-certificate validity period expires. In
contrast, according to the ICH Q7, whether to exe-
cute revalidation should depend on the results of
the periodic reviews of validated systems and the
product quality reviews (see 2.51 and 12.6).
IVTGXP_JULY07.qxd 6/18/07 11:39 AM Page 37
Documentation
According to ICH Q7, validation documents, e.g.,
all specifications, master production instructions, all
procedures impacting product quality, validation
protocols, and validation reports should be
approved by the Quality Unit (QU) (see 2.2).
In Chinese GMP, there are requirements on the
drafting, revising, reviewing, approving, withdrawing,
distributing, and retaining of validation documents,
but it is not mentioned that important validation
documents should be independently approved by
the quality management department. According to
the SFDAs book,6 the validation documents should
be jointly approved by the manager of the quality
management department and the responsible
vice-manager of the company. For the process
validation, any critical changes to validation proto-
cols should be jointly approved by the manager of
the quality management department and the man-
ager of the production management department.
Three kinds of document are described in
Chinese GMP: management documents and
records for production and quality control, production
control documents, and product quality control
documents (see Articles 61, 62, and 63). There
are relatively detailed requirements on production
control documents. However, for product quality
control documents and management documents,
there are no requirements on the contents, with
only the necessary document names listed.
In Chinese GMP, the master formula included in
the production control document contains product
name, dosage form, formula, the operational require-
ments of process, specifications of materials and
products, technical parameters, storage instructions,
reconciliation of materials, and requirements for
packaging materials and container used for finished
products (see Article 62). However, the following
contents required by ICH Q7 in the master produc-
tion instructions (see 6.4) are not mentioned, e.g.:
Xudong Xie, Ph.D.
The master production instructions should be
independently checked and approved by the
quality unit
Sampling instructions and in-process controls
with acceptance criteria
Time limits for completion of the individual
processing steps and/or the total process
Instructions for production storage
According to Chinese GMP, batch production
records of production control documents should
include the product name, batch number, production
date, signature of operator and checker, description
of related operations and equipment, quantity of rel-
evant production stages, reconciliation of material,
and process control records, as well as records of
abnormal problems (see Article 62). But the follow-
ing contents required by ICH Q7 in batch production
records (see 6.5) are not explicitly mentioned in
Chinese GMP, e.g.:
Actual results recorded for critical process
parameters
Any sampling performed
Description of packaging and label for
product
Representative label of product
Any deviation noted, its evaluation,
investigation conducted
Furthermore, there is no detailed requirement
on the following records (see 6.3, 6.6, and 6.7) in
Chinese GMP:
Records of raw materials, intermediates,
API labeling, and packaging materials
Laboratory control records
Batch production record review
J u l y 2 0 0 7 Vo l u m e 11 , N u m b e r 4 37
IVTGXP_JULY07.qxd 6/18/07 11:39 AM Page 38
Xudong Xie, Ph.D.
SUMMARY
In general, the Chinese GMP covers most of the
important aspects of pharmaceuticals production.
Some of the provisions are quite comparable to the
international GMP, e.g., requirements on clean-
rooms, personnel hygiene for cleanrooms, process
equipment, buildings and facilities, and materials
management. Nevertheless, there are some definite
differences between Chinese GMP and international
GMP ICH Q7. The most obvious differences are
summarized as follows:
The responsibilities of the quality manage-
ment department are limited and not compa-
rable to the responsibilities of the quality unit
described in ICH Q7.
Validation documents are not independently
approved by the responsible persons of the
quality management department.
The definition of the GMP starting point is not
required by Chinese GMP.
There is no recommendation on risk analysis
or equivalent procedures to identify the criti-
cal parameters or attributes.
Chinese GMP focuses mainly on the last
production steps of APIs (e.g., crystallization,
drying, blending, packaging), which are
required to be performed in cleanrooms of
the class 300,000 or better.
Revalidation does not depend on the results
of periodic reviews of validated systems and
product quality reviews.
There is no requirement on the periodic
assessment of the effectiveness of training.
Design qualification, cleaning validation,
validation of analytical methods, and valida-
tion of computerized systems are not legally
required by the Chinese GMP, although they
are described in the SFDAs technical book.
Some particular procedures are absent or not
described in detail, e.g., deviations, change
control, out-of-specification (OOS), repro-
cessing, reworking, recovery, etc.
38 Journal of GXP Compliance
ACKNOWLEDGMENTS
The author thanks Mr. Ralf Gengenbach,
Managing Director of gempex GmbH, for his
support during the preparation of this paper.
ABOUT THE AUTHOR
Dr. Xudong Xie is Validation Project Manager
at gempex GmbH, Mannheim, Germany. He
is Coordinator for validation projects in China.
Dr. Xie earned his Ph.D. in Chemistry from
University of Karlsruhe, Germany, and has over
15 years experience in instrumental analysis,
electrochemical sensor, and GMP. He can be
reached by telephone at (49) 621-819119-0
or by email at x-xie@gempex.com.
Permission to use this article was generously
granted by
REFERENCES
1. Drug Administration Law of the Peoples Republic of China,
2001, in Chinese and English
2. Regulations for Implementation of the Drug Administration
Law of the Peoples Republic of China, 2002, in Chinese
and English
3. State Foods and Drugs Administration (SFDA): Good
Manufacturing Practice for Pharmaceutical Products,
1998, in Chinese and English
4. State Foods and Drugs Administration (SFDA): Criteria
for the GMP Certification and Inspection (draft), 2006, in
Chinese
5. State Foods and Drugs Administration (SFDA): Guide
for the Validation of Drugs Production, Publishing House
of Chinese Medical Science, 2003, in Chinese
6. ICH: Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients (APIs) ICH Q7, 2002
7. European Commission: EU Guidelines to Good
Manufacturing Practice, Medicinal Products for Human
and Veterinary Use, 2005
8. State Foods and Drugs Administration (SFDA): Good
Manufacturing Practice for Pharmaceutical Products,
the Annex Special Requirements for the Production
Management and Quality Management of APIs, 1998
in Chinese
IVTGXP_JULY07.qxd 6/18/07 11:39 AM Page 39
9. State Foods and Drugs Administration (SFDA): Good
Manufacturing Practice for Pharmaceutical Products,
the Annex General Principle, 1998 in Chinese
API
EU
GMP
ICH
IQ
OOS
OQ
PQ
QA
QC
QU
SFDA
SOP
U.S.
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Article Acronym Listing
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