On January 22, 2013 the China SFDA published a Good Supply Practice guidance that will be implemented on June 1, 2013. Businesses will have a 3 year period to phase in the requirements and if this has not been accomplished by the deadline in 2016 they will be required to cease their activities. This is another demonstration that China is working diligently to upgrade the quality of their pharmaceutical manufacture and distribution networks. The guidance significantly increases the requirements for Quality Management. The relevant chapters include: General Provisions, Drug Wholesale Quality Management, Drug Retail Quality Management, and Supplementary provisions. Significant emphasis is placed on the standards to be implemented for computerized hardware and software systems. The use of controlled computerized systems is intended to both be an aid in protection of drug quality but will also serve as a barrier to entry into this part of the pharmaceutical business.

1. The new revision of “Good Supply Practice for Pharmaceutical Products was promulgated in January
22, 2013. This revision contains 187 articles in 4 Chapters. There is a 3-year transition period for
implementation of newly revised GSP. The four chapters are:
Chapter 1: General Principles
Chapter 2: Quality Control for Wholesale Drug
Chapter 3 Quality Control of Retail Drugs
Chapter 4 Supplementary Provisions
The revision includes new requirement and systems such as
Supply chain management
IT-based management (facilities, network environment, database and functions of applied
software)
Automatic monitoring of storage temperature and humidity.
Cold chain management
Quality risk management, system internal evaluation and equipment validation
Issuance of invoice for drug procurement and supply
Shipping order and performance of inspection upon delivery for drugs distributed from
warehouse
Consistency among invoice, account and actual goods
Examination of transportation capabilities/quality assurance and signing of quality assurance
agreement with suppliers (e.g. 3rd Party Transportation)
Chapter 1: General Principles
These guidelines are to be implemented by Pharmaceutical operation enterprises and drug
manufacturing enterprises involved in the storage and transportation of drugs in the process
of drug sales and distribution. The objectives are to strengthen quality control (QC) in the
distribution of drugs, regulate drug distribution activities, and ensure safe and effective use
of drugs by people.
Chapter 2: Quality Control for Wholesale Drug
Section 1: Quality Control System
The aim is identification of overall quality objectives and implementation of requirements
throughout the entire process of pharmaceutical operation. The overall objectives are:
Performance/analysis of outcomes of internal evaluation for compliance to GSP and
resulting continuous improvements/sustainable and effective operation of QC systems
Evaluation, control, communication and verification of risk in quality during drug distribution
through forecast or review.
Evaluation and where necessary, site inspection of supplier’s and buyer’s QC system to
confirm QA capabilities/quality reputation.
Section 2: Organizational Structure and Quality control Responsibilities
This section Describes establishment of organizational structure/positions, qualifications, duties, and
responsibilities, powers (e.g. authority of employee responsible for QC over drug quality issues) and

2. interrelationships (e.g. responsible person’s daily management and provision of conditions for
effective performance of QC department/personnel for achievement of quality objectives and
compliance with the GSP). Independence of QC department and performance of QC duties only by
QC personnel including but not limited to:
Verification of legitimacy/changes thereto of drug suppliers, buyers, purchased drugs and
legal qualification of sales personnel of drug suppliers and procurement personnel of buyers
Inspection/acceptance of drugs and supervision of QC activities e.g. in procurement, storage,
preservation, sales, refund and transportation of drugs
Confirmation/supervision of unqualified drugs
Investigation, handling, and reporting of drug quality complaints/incidents/inquiry,
fake/inferior drugs, recalls, and adverse drug reactions
Organization of validation/qualification/calibration for relevant facilities and equipment
including IT system
Investigation/evaluation of QC system and service quality of suppliers and buyers
Review of transportation conditions and QA capabilities of carriers
Performance of internal evaluation and risk assessment of QC systems as well as QC
education/training
Section 3: Staff and Training
This section describes qualification requirements prescribed in relevant laws/regulations and this
GSP.
Wholesale enterprise employees to include such positions as QC, inspection/acceptance and
preservation/storage, procurement , employees responsible for storage and transportation
of drugs under special management and drugs stored in a refrigerator or freezer whose
qualification/requirements/duties are indicated.
Requirements for documented pre-employment and continuing training relevant to job
responsibilities/scope of work (e.g. laws & regulations, professional pharmaceutical
knowledge and skills, quality control system, responsibilities & position operation
procedures)
Employee personal hygiene management system/gowning in such positions as storage and
transportation shall meet requirements of personal protection and product protection
(including those with disease that may contaminate the drugs are not to engage in activities
that are in direct contact with drugs)
Failing health conditions or failure to meet requirements for positions are not to engage in
relevant work activities.
Section 4: Quality Control System Documents
This section deals with the document creation/revision, review, approval, archiving, etc. follows
document management operation procedures. QC system to include but not limited to:
Qualification review for suppliers, buyers and sales personnel of suppliers, as well as
employees of buyers
Management of drug procurement, delivery, inspection and acceptance, preservation, sales,
shipment and transportation
Requirement for drugs under special management

3. Management of storage and preservation, verification, and calibration of
facilities/equipment/IT system
Implementation of electronic drug supervision – Departments (e.g. QC), responsible person,
position for QC, procurement, delivery, receipt/shipment inspection/acceptance, storage
(including records), preservation, sales/returns, transportation, finance, and information
management/IT system job responsibilities and requirements for operating
procedures/records/traceability of such processes are described.
Section 5: Facilities and Equipment
This section deals with the requirements of business site/warehouse commensurate with scope of
drug business operation.
Documented site selection, design, layout (including zoning for different operations/purpose),
construction, upgrade and maintenance/cleaning/inspection of warehouse/facilities shall meet the
requirements on drug storage (i.e. reasonable/safe- e.g. security/limited access to avoid theft or
replacement of drugs/mixture of counterfeit drugs, prevent impact of extreme weather conditions,
dedicated storage sites, use of appropriate equipment/automatic monitoring/recording/alarm
devices e.g. for refrigerators/freezers including those for transportation vehicle, etc.) and avoid drug
contamination, cross-contamination, confusion and mistake.
Section 6: Calibration and Verification
The requirements for the performance of verification (pre-use and continuing) and calibration of
facilities/equipment e.g. refrigerator/freezer including those for transportation vehicle and use in a
proper and reasonable manner in accordance with verified parameters and conditions has been
described.
Section 7: IT system
This section deals with the establishment of IT system considering drug quality traceability and meet
conditions for the implementation of electronic drug supervision and meet the following
requirements but not limited to:
Server and terminal to support the system’s normal operation supported by secured and
stable network environment, landline Internet access/reliable information platform, local
area network , and applied software/relevant database including functionality e.g.
generation, printing and management of pharmaceutical operation business invoice
Operations (including corporate operation/management) e.g. data entry/editing/saving)
consistent with the requirements on the scope of authorization, operating procedures and
management systems to ensure the originality, truthfulness, accuracy, security and
traceability of data including secured storage and backup
Section 8: Procurement
Procurement activities to include but not limited to the following requirements:
Confirmation of supplier’s legal eligibility & legitimacy of purchased drugs
Verification of legal qualification of sales employees of suppliers
Signed QA Agreements with suppliers (including responsibilities of both parties, and
www.Rxdrug transportation, and site inspection/evaluation of QC system)

4. Requirements (including required relevant documentation/record retention) for firsttime
suppliers, initially handled drugs, drugs under special management involved in procurement
are identified thereto
Documentation/evaluation/record retention requirements for procurements of drugs (e.g.
invoice and required data) and procurement in the event of special situations (e.g. disaster,
etc.) are identified thereto
Requires periodic comprehensive quality evaluation for the overall situation of drug
procurement, drug quality evaluation and supplier quality records, and dynamic follow-up
management
Section 9: Receiving and Inspection of Goods
The objective of this section it to prevent entry of unqualified drugs via receipt inspection according
to procedures/requirements (including verification of information concerning mode of
transport/conditions e.g. temperature/duration, shipping order, representative
sampling/acceptance/rejection, etc.).
Section 10: Storage and Preservation
Requirements for proper storage of drugs to meet the following but not limited to:
Appropriate temperature and humidity requirements or those prescribed in Pharmacopoeia
of the People’s Republic of China
Special storage handling requirements (e.g. color labeling for manual warehouse,
stacking/placement, protection and shade from light, ventilation, moisture prevention,
including insect and rat prevention)
Cleanliness of storage area (including facilities/equipment and limited access into storage
areas– Preservation of drugs ( e.g. according to warehouse condition, external environment,
etc.) and storage of questionable drugs under lock/recorded in IT system including
automatic tracking/control of shelf life of warehoused drugs
Prevention/protection from contamination including
handling/storage/documentation/disposition/preventive measures for suspicious/drugs
with quality problems
Periodic inventory/reconciliation of drugs
Section 11: Sales
Drugs are sold legitimate buyers (verified proof documents, identity proof of procurement and
delivery personnel to ensure truthful/legitimate flow of drug sales and issues sales invoice to ensure
consistency among invoice, account, goods and fund and keep records of drug sales having
appropriate information listed thereto
Section 12: Drug Distribution from Warehouse
Drug distribution from warehouse are verified versus sales record and are
prohibited/reported to QC department for defects (e.g. damaged, contaminated, leakage,
labelling defects, expired, other abnormal conditions)
Verification records (with appropriate information listed thereto) of distribution of drugs
(including drugs under special management verified according to relevant regulation) are
established as required
Consolidated shipment will be labelled as such (on package containers)

5. Shipping order/ticket of original stamp for drug distribution from warehouse are attached,
special provisions provided for direct delivery of drugs
Container/truck loading operations, etc. of refrigerated or drugs stored in freezer are carried
out under supervision of assigned personnel and meet requirements identified thereto (e.g.
meeting/inspected for corresponding temperature requirements and transportation
recorded with appropriate information)
Conduct code scanning and data uploading for drugs subject to electronic supervision
Section 13: Transportation and Delivery
Execute transportation operation procedures as required by QC system to ensure drug
quality and safety (including those drugs under special management)
Transport vehicles are identified and appropriate for drug packaging, quality attributes and
control requirements to prevent problems (e.g. damage and contamination) and are
monitored on real-time basis as appropriate (e.g. for temperature). Emergency plan are
available/applied (e.g. during equipment failure, abnormal weather) occurring during
transportation
Where applicable, entrusted drug transportation entity shall be audited for QA
capabilities/other relevant information about transport vehicles/meeting prescribed
requirements for transport facilities and equipment, and a transportation agreement
generated/record kept (min 5 years) clarifying responsibilities and compliance to transport
operation procedure/estimated time en-route and other relevant transportation
information and requirements (e.g. delivery time and address, transport mode,
shipped/delivered after loading, etc.)
Transportation security management measures are employed to prevent incidents (e.g.
theft, loss, counterfeiting)
Section 14: After-sales Management
Includes management (e.g. handling, appropriate notification/reporting, documentation, evaluation,
monitoring, etc.) of returned goods, complaints, recalls, and adverse drug reactions
Chapter 3 Quality Control of Retail Drugs
Section 1 Management Duties
Includes but not limited to:
Development/implementation of QC system/documents, appropriate operational
conditions/organizational structure, personnel, facilities and equipment, and IT system
Responsible persons major responsibilities for quality of drugs sold, corporate day-to-day
management including provisions of appropriate conditions for effective fulfillment of duties
for QC department/personnel and compliance with the GSP including but not limited to:
Review/qualification of suppliers and their sales employees
Review legitimacy of purchased drugs
Performance of inspection/acceptance of drugs and oversee QC activities (e.g. drug
procurement, storage, display and sales)
Management (e.g. handling, appropriate notification/reporting, documentation, evaluation,
monitoring, etc.) of drug quality inquiry/information, complaints/incidents, unqualified
drugs, counterfeit/inferior drugs, and adverse drug reactions, and pharmacological service
activities

6. Review/conduct/organize QC education/training, IT systems operation
authority/maintenance of basic QC data, and calibration/verification of measuring
instruments
Section 2: Personnel Management
Legal representative/responsible person is a licensed pharmacist – Quality control,
inspection, acceptance and procurement, and sales personnel possesses qualification
requirements indicated thereto
Establish training management system and employees to receive documented relevant pre-
employment and continuing training as indicated thereto
Section 3: Documentation
Establish QC documents (e.g. QC systems, job responsibilities, procedures, etc.), properly
understood/effectively implemented, reviewed and timely revised
QC system to include but not limited to:
o Review of suppliers and drug products for procurement
o Management of drugs under special management/drugs subject to separate
national management requirements, records and certificates, collection/inquiry of
quality information, quality incidents/complaints, IT system, electronic drug
supervision, etc.
o Clarify responsibilities of corporate responsible persons and other positions
(including storage and preservation positions/procedures where a warehouse is
established)
o Duties of QC and formulation review positions are not performed by personnel of
other positions on their behalf
o Drug retail operation procedure to include but not limited to:
o Procurement, inspection, acceptance and sales of drug products
o Refrigerated storage of drug products
o Operation/management of IT system (security/authorization, accuracy, back up,
etc.)
o Establishment of relevant records/records retention (minimum 5 years)
Section 4: Facilities and Equipment
Business location compatible with scope and scale of drug operation, separate from areas
for drug storage, office work, utility area and other areas and have proper facilities/other
effective measures in place to prevent the impact of outdoor environment on drug products
and be spacious, bright, tidy and clean and have business equipment listed thereto
Establishment of IT system in line with requirements of business operation/QC meeting
conditions for the implementation of electronic drug supervision
If retail enterprise has a warehouse, it should meet the requirements and have facilities and
equipments as described thereto (including special warehouse for traditional Chinese
medicine preparations and calibration/verification of measuring and monitoring
instruments/equipment)
Section 5: Procurement, Inspection and Acceptance
Compliance with relevant Chapter 2 Section 8: Procurement (drug products) of GSP

7. Conduct/handling of drug product receipt, verification/representative
sampling/inspection/acceptance/rejection/documentation/reporting as per prescribed
procedures/requirements thereto (ensuring consistency among shipping ticket, account and
actual goods including drug products under special management and those subject to
electronic supervision)
Section 6: Display and Storage
Requires monitoring, control and compliance to room temperatures (business venues)
Requirement for periodic hygiene inspection and cleanliness of equipment for storage and
display of drug products including measures (e.g. insect and rat prevention) to prevent
contamination to drug products
Display, inspection/reporting/documentation (on display and storage) of drug products shall
meet requirements as described thereto
Tracking of drug product shelf life to prevent possible use of expired/near shelf-life drugs
Compliance to relevant provisions of Chapter 2 Section 10 of the GSP (if retail enterprise has
established warehouse)
Section 7: Management of Sales
Requirements for display of Drug Operation License, Business License, Registration
Certificate of Licensed pharmacists, etc. to visible locations of its business venue
Compliance to proper identification of sales person/signboard indicating licensed
pharmacists on duty
Compliance to requirements for sales of drugs as indicated thereto
Issuance/documentation of sales invoice with appropriate information and sales record
Compliance to requirements of retail sale of drug products as identified thereto
Compliance to requirements/national regulations for drugs under special management and
drug advertising
Prohibition of sale of drugs by non-retail enterprise employees
Required scanning of codes and data upload upon sale for drugs subject to electronic
supervision
Section 8: After-sales Management
Other than quality reasons, no drug product refund or replacement after sale
Requirement for display of supervision hotline of drug administration department at its
business location, establish a customer feedback book and timely handling of customer
complaints on drug quality.
Collection and reporting of adverse drug reactions and after-sales drug product quality
problems in accordance with national regulation including assisting drug manufacturers for
recall (e.g. documentation/record and reporting to drug administration department), as
applicable
Chapter 4 Supplementary Provisions
Compliance to relevant regulations (drug wholesale or retail)
GSP prescribes basic requirement on the QC of drug operation.
Other specific requirements are stipulated by SFDA through appendices (e.g. IT-based
corporate management, management of drug cold chain logistics, etc.)

8. Provision of Definitions of terminologies in the GSP
Non-compliance of drug operation enterprise against this GSP is punishable by drug
administration departments in accordance with Article 79 of Drug Administration Law of the
People’s Republic of China