The Main Differences Between Chinese GMP and the ...

30 Journal of GXP Compliance

The Main Differences BetweenChinese GMP and the International

GMP – ICH Q7

By Xudong Xie, Ph.D.

ABSTRACT

In this paper, a brief introduc-tion of Chinese GMP with respectto legislation, guidelines, and theGMP certification system is given.This is followed by a comprehen-sive comparison of Chinese GMPwith international GMP – ICH Q7,covering the main aspects ofGMP starting point, productquality management, personnel,buildings and facilities, materialsmanagement, production management, validation as well as documentation. Thecharacteristics of Chinese GMP with respect to methods,procedures, operations, anddocumentation for the manufac-ture of pharmaceutical productsare especially emphasized.

INTRODUCTION

The implementation of goodmanufacturing practice (GMP) isan effective measure for assuringthe quality, safety, and effective-ness of pharmaceutical products.With the rapid development ofChina’s economy, GMP has

become more and more impor-tant for Chinese pharmaceuticalcompanies, especially for thosethat want to export their productsto the world market. Awarenessof the differences between theChinese GMP and the interna-tional GMP would be helpful both for Chinese companies tomanufacture their products meet-ing international GMP require-ments, and for foreign companies entering the Chinese market tobetter know the characteristics ofChinese GMP and consequentlyto assure product quality whenmaterials sourcing.

In the last decade, new legis-lation, regulations, and guidelinesgoverning the manufacture ofpharmaceutical products havebeen promulgated in China, e.g., Drug Administration Law of China (2001),1 Regulations for Implementation of the DrugAdministration Law of China(2002),2 Good ManufacturingPractice for Pharmaceutical Products (1998),3 Criteria for theGMP Certification and Inspection(2006)4 as well as the Guide for

Appreciation of the distinctions

between the Chinese GMP andthe International

GMP helps companies

entering the Chinese market to better under-stand Chinese

regulations and to secure theirplace in that

market.

IVTGXP_JULY07.qxd 6/18/07 11:39 AM Page 30

Xudong Xie, Ph.D.

31July 2007 • Volume 11, Number 4

the Validation of Drug Production (2003).5

The current Chinese GMP – Good ManufacturingPractice for Pharmaceutical Products was amendedand issued as regulation by the State Foods andDrugs Administration (SFDA) of China in 1998.3

Based on the former 1992 version, it includes 14chapters and 88 articles, covering organization andpersonnel, building and facilities, equipment, mate-rials, hygiene and sanitation, validation, documen-tation, production management, quality manage-ment, production distribution and recall, complaintsand adverse reactions report, and self-inspections.In addition, it encompasses six appendices, whichare supplementary provisions for the asepticdrugs, non-aseptic drugs, active pharmaceuticalingredients (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 ofpharmaceuticals (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 theSFDA in 2006 based on Chinese GMP regulation.4

There are 268 inspection items in this criteria intotal, including 115 critical items and 153 non-criti-cal items. Chinese GMP certification is based onassessment of on-site inspection results (see Figure 1). Such GMP certification is valid for five

years. After the validity period has transpired, a fullinspection will be conducted by SFDA to checkwhether the drugs manufacture still meets theGMP requirements.

In order to guide the Chinese pharmaceuticalcompanies to carry out validation activities, aGuide for the Validation of Drug Production waspublished by SFDA in 2003 in Chinese6, which waswritten by experts from various major Chinesepharmaceutical companies. This book focusesmainly on theories, methods, and procedures aswell 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 stressedthat this book is only a technical reference book forthe validation of drug production and is not legallyrequired by the SFDA.

This article focuses mainly on the comparison ofChinese GMP and ICH Q7 – Good ManufacturingPractice Guide for Active Pharmaceutical Ingredi-ents (APIs),6 covering mainly the aspects of GMPstarting point, personnel, quality management, build-ings and facilities, materials management, produc-tion management, validation, and documentation.

Figure 1Criteria for the GMP Certification and Inspection*

00! 30! 3> 3

! 20%21 - 40%! 20%> 40%> 20%

Qualified for the GMP certificationCorrective actions should be taken within 6 months and inspection will be done again

Not qualified for the GMP certification

Deficiencies Found During Inspection Results

Number of Critical Items

Percentage of Non-Critical Items

* SOURCE: CRITERIA FOR THE GMP CERTIFICATION AND INSPECTION4


Xudong Xie, Ph.D.


COMPARISON OF CHINESE GMP AND ICH Q7

Scope and GMP starting point

ICH Q7 applies only to the manufacture of APIsfor use in human drug (medicinal) products (see1.3). In comparison, Chinese GMP is applicable tothe manufacture of both finished products andactive pharmaceutical ingredients (APIs) (see Article2). However, it should be mentioned that the ICHQ7 incorporated into the EU GMP – EU Guidelinesto Good Manufacturing Practice Medicinal Productsfor Human and Veterinary Use extends the scope ofapplication to animal drug products.7

In the ICH Q7 guideline, an “API starting material”is defined as:

“a raw material, intermediate, or an APIthat is used in the production of an APIand is incorporated as a significantstructural fragment into the structure ofthe API. API starting materials normallyhave defined chemical properties andstructure.”

The guideline requires also that:

“the company should designate anddocument the rationale for the point atwhich production of the API begins” and“from this point on, appropriate GMP asdefined in this guide should be appliedto these intermediate and/or API manu-facturing steps.” (See 1.3.)

In Chinese GMP, a definition of starting materialand GMP starting point is not given. The onlyrequirement prescribed in the supplementary provi-sion for the APIs production and quality control (i.e.,the annex for APIs) is that the batch productionrecords of APIs should be started at the latest fromthe refinement of crude product, which could besimilar 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 beappropriate for later processing steps (e.g., isolationand purification steps) (see 8.31). In comparison,

Chinese GMP focuses mainly on the last productionprocess steps from the crystallization, which arerequired to be executed in cleanrooms (see theannex for APIs).8

Personnel

The ICH Q7 requires that there should be anadequate number of personnel qualified by appro-priate education, training, and/or experience to per-form and supervise the production of intermediatesand APIs (see 3.1).

In Chinese GMP, there are more detailedrequirements on the education of the responsiblepersons of company management, productionmanagement, and quality management. Thosepersons should have at a minimum a collegedegree of medicine, pharmaceuticals, or relatedsciences. The responsible persons of the qualitymanagement department and the production man-agement department should be independent ofeach other (see Articles 4 and 5). Training for per-sonnel engaged in production and quality control ofdrugs is needed according to Chinese GMP, butthere is no requirement on the periodical assess-ment of the effectiveness of training, althoughtraining examination is required (see Article 7).

Concerning the personnel hygiene, ChineseGMP requires additionally that health files of drugproduction personnel be established. For productionpersonnel with direct contact with drugs, a physicalexamination should be conducted at least annually(see Article 56). Generally, Chinese GMP focusesmore on personnel hygiene in cleanrooms.

Quality Management

According to ICH Q7, there should be an effectivesystem for managing quality which should encom-pass the organizational structure, procedures,processes, and resources, and necessary activitiesto ensure that products will meet the intended speci-fications for quality and purity. For this purpose, theresponsibilities of the quality unit and responsibilityfor the production activities are specified, and inter-nal audits and product quality reviews are required.Moreover, in this quality management system, thequality unit (QU) must be independent from the pro-duction unit, fulfilling both quality assurance (QA)and quality control (QC) responsibilities (see 2.1).


Xudong Xie, Ph.D.


Figure 2Comparison of Responsibilities of Quality Unit and Quality Management Department

• Releasing or rejecting all APIs. Releasingor rejecting intermediates for use outsidethe control of the manufacturing company

• Reviewing completed batch production andlaboratory control records of critical processsteps before release of the API for distribu-tion

• Establishing a system to release or rejectraw materials, intermediates, packaging,and labeling materials

• Approving intermediate and API contractmanufacturers

• Approving all specifications and master pro-duction instructions

• Ensuring that materials are appropriatelytested 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 whereappropriate

• Ensuring that critical deviations are investi-gated and resolved

• Approving all procedures impacting thequality of intermediates or APIs

• Approving changes that potentially impactintermediate 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 areinvestigated and resolved

• Ensuring that effective systems are usedfor maintaining and calibrating criticalequipment

• Performing product quality review

• Reviewing batch production records anddeciding on the release of final products

• Deciding on the use of materials and inter-mediates

• Evaluating the quality systems of criticalmaterial suppliers together with other relateddepartments

• Establishing in-house specifications and ana-lytical procedures of materials, intermediates,and finished products, including samplingand sample retention procedures

• Sampling, testing, retaining samples of mate-rials, intermediates, and finished productsand issuing analytical reports

• Evaluating the stability of raw materials, inter-mediates, and finished products, and provid-ing data for determining the storage period ofmaterials and the expiration date of the drug

• Reviewing the treatment procedure ofrejected products

• Monitoring the particulates and microorgan-isms in the cleanrooms (areas)

• Establishing the procedures for controllingtesting equipment, instrument, reagent, test-ing solution, standard substance (or refer-ence substance), titration solution, culturemedium, experiment animals, etc.

• Establishing the responsibilities of the per-sons engaged in quality management andquality test

Quality Unit - ICH Q7 Quality Management Department –Chinese GMP


Xudong Xie, Ph.D.


In Chinese GMP, there is a quality managementdepartment which is responsible for quality controland testing of drugs. The quality managementdepartment should be led directly by the responsiblemanagement of the company. The responsible per-sons of the quality management department and theproduction management department should beindependent of each other (see Articles 5 and 74).In general, the quality management department ofChinese 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 qualityunit of ICH Q7 and the responsibilities of the qualitymanagement department of the Chinese GMP areshown in Figure 2 (see ICH – 2.2 and ChineseGMP – Article 75).

According to ICH Q7, a product quality review toverify the consistency of process should be annuallyconducted and adequate corrective action should betaken. Such reviews focus on at least (see 2.5):

• Critical in-process control and critical testresults

• All batches that failed to meet establishedspecifications

• All critical deviations or non-conformancesand related investigations

• Any changes carried out to the processes oranalytical methods

• Results of the stability monitoring program

• All quality-related returns, complaints andrecalls

• 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 appropriatelyarranged. Whether buildings are appropriatelylocated in accordance with the production processflow and the required air cleanliness classes, is con-sidered to be one of the critical items during theSFDA’s 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 definedareas or other control systems for all the followingactivities required by ICH Q7 are to be consideredduring the design and construction of buildings andfacilities (see 4.14):

Figure 3The Classification of Cleanrooms – Chinese GMP*

* SOURCE: THE ANNEX OF THE CHINESE GMP – GENERAL PRINCIPLE9

Grade of Air Cleanliness

Maximal Permitted Number of Particles /m3

Maximal Permitted Number of Microorganisms

! 0.5 µm ! 5 µm Air Sample(cfu/m3)

Settle Plates(cfu/plate)

100 3,500 0 5 1

10,000 350,000 2,000 100 3

100,000 3,500,000 20,000 500 10

300,000 10,500,000 60,000 - 15


Xudong Xie, Ph.D.


• Receipt, identification, sampling, and quaran-tine of incoming materials, pending, release orrejection

• 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 cleanroomsin Chinese GMP. However, for the classification of air cleanliness grade, there are differences betweenChinese GMP and international GMP (see Figure 3and Figure 4). For example, the air cleanliness classof 300,000 in Chinese GMP is an unknown class forforeign countries.

According to Chinese GMP, the last productionsteps of APIs (e.g., refinements, drying, and packag-ing) should be conducted in cleanrooms of not lowerthan class 300,000. For APIs with legal microbiologi-cal control requirements, they should be processed incleanrooms 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.

Material Management

According to Chinese GMP, the managementsystems for purchase, storage, dispatching, and use,etc., of materials used for production should beestablished (see Article 38). However, there is noexplicit requirement on the following activities, e.g.(see ICH Q7, Section 7):

• Changing the source of supply of critical rawmaterials should be treated according tochange control

• Materials stored in fiber drums, bags, orboxes should be stored off the floor and suit-ably spaced to permit cleaning and inspection

• Sampling should be conducted at definedlocations

• Materials should be re-evaluated to deter-mine their suitability for use

• Full analysis should be conducted on at leastthree batches before reducing in-house testing

Production Management

In Chinese GMP there are mainly four kinds ofproduction management documents, e.g., masterformula, job position instruction, standard operatingprocedure (SOP), and batch production records(see Article 62). The operational requirements forprocess and in-process control are only mentionedin the master formula and batch production recordswithout detailed contents. The following contents

Figure 4The Classification of Cleanrooms – EU GMP*

* SOURCE: THE ANNEX 1 OF THE EU GUIDELINES TO GMP – MANUFACTURE OF STERILE MEDICINAL PRODUCTS7

Grade of Air Cleanliness

Maximal Permitted Number of Particles /m3

Recommended Limits for Microbial Contamination

! 0.5 µm ! 5 µm Air Sample(cfu/m3)

Settle Plates(diam. 90mm, cfu/4h)

A 3,500 1 < 1 < 1

B 3,500 1 10 5

C 350,000 2,000 100 50

D 3,500,000 20,000 200 100


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 andexplained. Any critical deviation should beinvestigated.

• If time limits are specified in the master pro-duction instruction, these time limits shouldbe met to ensure the quality of intermediatesand APIs. Deviations should be documentedand evaluated.

• In-process controls and their acceptance cri-teria should be defined based on the informa-tion gained during the development stage orhistorical data or today’s risk analysis.

• Critical in-process controls, including controlpoints and methods, should be stated in writ-ing and approved by the quality unit.

• In-process sampling should be conductedusing procedures designed to prevent contam-ination of the sampled material and other prod-ucts. Procedures should be established toensure the integrity of samples after collection.

• Blending is defined as the process of combin-ing materials within the same specification toproduce a homogeneous product. Acceptableblending operations include mainly:

! Blending of small batches to increasebatch size

! Blending of tailings from batches of thesame product to form a single batch

In ICH Q7, there are clear definitions andrequirements to guide rejection, reprocessing,reworking, and recovery during the drugs production(see Section 14). However, requirements on suchactivities are not prescribed in Chinese GMP. More-over, operational procedures for deviation, changecontrol, and out-of-specification (OOS) required byICH Q7 (see 6.53, 11.15, and Section 13) are alsoabsent in Chinese GMP.

Validation

Nowadays, risk analysis is highly recommendedduring the validation of drug production even if notdirectly outlined within the international GMP (ICH,U.S., EU). Before starting validation, a comprehen-sive risk analysis is conducted to define the APIs interms of critical product attributes, to identifyprocess parameters that could affect the criticalquality attributes of the APIs, and to determine therange for each critical process parameter expectedto be used during routine manufacturing andprocess control. However, there is no such recom-mendation on risk analysis or equivalent measuresfor validation in Chinese GMP.

In Chinese GMP, the requirements on validationare very briefly described, including mainly the qual-ification (IQ/OQ/PQ) of buildings, facilities andequipment, validation of production process, changecontrol, revalidation, as well as documentation (seeChapter 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 validationof computerised systems are not officially mentionedin Chinese GMP, although those validation activitiesare described in the SFDA’s technical book – Guidefor the Validation of Drug Production6.

Chinese GMP stipulates that revalidation shouldbe conducted at defined intervals or after any signifi-cant changes that may affect the product quality,e.g., changes of production process, quality controlmethod, critical raw material and excipient, and criti-cal equipment (see Article 58). But it should bestressed that detailed requirements on change con-trol procedures cannot be found in Chinese GMP. Afull revalidation is also required by Chinese GMPwhen the GMP-certificate validity period expires. Incontrast, according to the ICH Q7, whether to exe-cute revalidation should depend on the results ofthe periodic reviews of validated systems and theproduct quality reviews (see 2.51 and 12.6).


Xudong Xie, Ph.D.


Documentation

According to ICH Q7, validation documents, e.g.,all specifications, master production instructions, allprocedures impacting product quality, validation protocols, and validation reports should beapproved by the Quality Unit (QU) (see 2.2). In Chinese GMP, there are requirements on thedrafting, revising, reviewing, approving, withdrawing,distributing, and retaining of validation documents,but it is not mentioned that important validation documents should be independently approved bythe quality management department. According tothe SFDA’s book,6 the validation documents shouldbe jointly approved by the manager of the qualitymanagement 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 ofthe quality management department and the man-ager of the production management department.

Three kinds of document are described in Chinese GMP: management documents andrecords for production and quality control, productioncontrol documents, and product quality control documents (see Articles 61, 62, and 63). There are relatively detailed requirements on productioncontrol 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 inthe production control document contains productname, dosage form, formula, the operational require-ments of process, specifications of materials andproducts, technical parameters, storage instructions,reconciliation of materials, and requirements forpackaging materials and container used for finishedproducts (see Article 62). However, the followingcontents required by ICH Q7 in the master produc-tion instructions (see 6.4) are not mentioned, e.g.:

• The master production instructions should beindependently checked and approved by thequality unit

• Sampling instructions and in-process controlswith acceptance criteria

• Time limits for completion of the individualprocessing steps and/or the total process

• Instructions for production storage

According to Chinese GMP, batch productionrecords of production control documents shouldinclude the product name, batch number, productiondate, signature of operator and checker, descriptionof related operations and equipment, quantity of rel-evant production stages, reconciliation of material,and process control records, as well as records ofabnormal problems (see Article 62). But the follow-ing contents required by ICH Q7 in batch productionrecords (see 6.5) are not explicitly mentioned in Chinese GMP, e.g.:

• Actual results recorded for critical processparameters

• 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) inChinese GMP:

• Records of raw materials, intermediates, API labeling, and packaging materials

• Laboratory control records

• Batch production record review


Xudong Xie, Ph.D.


SUMMARY

In general, the Chinese GMP covers most of theimportant aspects of pharmaceuticals production.Some of the provisions are quite comparable to theinternational GMP, e.g., requirements on clean-rooms, personnel hygiene for cleanrooms, processequipment, buildings and facilities, and materialsmanagement. Nevertheless, there are some definitedifferences between Chinese GMP and internationalGMP – ICH Q7. The most obvious differences aresummarized as follows:

• The responsibilities of the quality manage-ment department are limited and not compa-rable to the responsibilities of the quality unitdescribed in ICH Q7.

• Validation documents are not independentlyapproved by the responsible persons of thequality management department.

• The definition of the GMP starting point is notrequired by Chinese GMP.

• There is no recommendation on risk analysisor 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 arerequired to be performed in cleanrooms ofthe class 300,000 or better.

• Revalidation does not depend on the resultsof periodic reviews of validated systems andproduct quality reviews.

• There is no requirement on the periodicassessment of the effectiveness of training.

• Design qualification, cleaning validation, validation of analytical methods, and valida-tion of computerized systems are not legallyrequired by the Chinese GMP, although theyare described in the SFDA’s technical book.

• Some particular procedures are absent or notdescribed in detail, e.g., deviations, changecontrol, out-of-specification (OOS), repro-cessing, reworking, recovery, etc. !

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 bereached by telephone at (49) 621-819119-0 or by email at [email protected].

Permission to use this article was generouslygranted by

REFERENCES

1. Drug Administration Law of the People’s Republic of China,

2001, in Chinese and English

2. Regulations for Implementation of the Drug Administration

Law of the People’s 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



the Annex – Special Requirements for the Production

Management and Quality Management of APIs, 1998

in Chinese


Xudong Xie, Ph.D.




the Annex – General Principle, 1998 in Chinese

Article Acronym Listing

API Active Pharmaceutical IngredientEU European UnionGMP Good Manufacturing PracticeICH International Conference on

HarmonizationIQ Installation QualificationOOS Out-Of-SpecificationOQ Operational QualificationPQ Performance QualificationQA Quality AssuranceQC Quality ControlQU Quality UnitSFDA State Foods and Drugs

Administration (China)SOP Standard Operating ProcedureU.S. United States

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