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GB/T 42502-2023 (GBT42502-2023)

GB/T 42502-2023_English: PDF (GBT 42502-2023, GBT42502-2023)
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BASIC DATA
Standard ID GB/T 42502-2023 (GB/T42502-2023)
Description (Translated English) Specification for auditing quality management of pharmaceutical logistics
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard A00
Classification of International Standard 03.120.10
Word Count Estimation 10,136
Date of Issue 2023-03-17
Date of Implementation 2023-03-17
Drafting Organization China Federation of Logistics and Purchasing, Shanghai Pharmaceutical Logistics Center Co., Ltd., Anhui Zhongke Duling Commercial Appliance Co., Ltd., Guangzhou KingMed Medical Testing Group Co., Ltd., China Biotechnology Co., Ltd., Lilly Suzhou Pharmaceutical Co., Ltd., Qilu Pharmaceutical Group Co., Ltd., Lunan Pharmaceutical Group Co., Ltd., Guangzhou Jinyuda Logistics Co., Ltd., Sinopharm Pharmaceutical Logistics Co., Ltd., Jointown Pharmaceutical Group Logistics Co., Ltd., Guangzhou Pharmaceutical Co., Ltd., SPH Keyuan Xinhai Pharmaceutical Co., Ltd. Company, Ruikang Pharmaceutical (Shandong) Co., Ltd., Qingdao Baheal Pharmaceutical Co., Ltd., East China Pharmaceutical Supply Chain Management (Hangzhou) Co., Ltd., Jiangxi Wuzhou Pharmaceutical Marketing Co., Ltd., Anhui Tianxing Pharmaceutical Group Co., Ltd., Hunan Tianrun Biomedical Co., Ltd. responsible company
Administrative Organization National Logistics Standardization Technical Committee (SAC/TC 269)
Issuing agency(ies) National Logistics Standardization Technical Committee (SAC/TC 269)

Standards related to: GB/T 42502-2023

GB/T 42502-2023
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 03.120.10
CCS A 00
Specification for auditing quality management of
pharmaceutical logistics
ISSUED ON: MARCH 17, 2023
IMPLEMENTED ON: MARCH 17, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Basic requirements for auditors ... 6
5 Audit work requirements ... 6
6 Audit content ... 7
7 Audit judgment ... 11
8 Audit results and feedback ... 11
9 Evaluation and improvement ... 11
References ... 13
Specification for auditing quality management of
pharmaceutical logistics
1 Scope
This document stipulates the basic requirements for pharmaceutical logistics quality
management auditors, audit work requirements, as well as audit content, audit judgment,
audit results and feedback, and evaluation and improvement requirements.
This document is applicable for auditing pharmaceutical logistics service providers by
pharmaceutical logistics quality management auditors.
2 Normative references
The following documents contain the provisions which, through normative reference in
this document, constitute the essential provisions of this document. For the dated
referenced documents, only the versions with the indicated dates are applicable to this
document; for the undated referenced documents, only the latest version (including all
the amendments) is applicable to this document.
GB/T 28842 Operation specifications for medicinal product cold chain logistics
GB/T 30335 Service specification of drug logistic
GB/T 34399 Temperature control facilities of pharmaceutical products cold chain
logistics - Specification for performance qualification
GB/T 35145 Cold chain temperature logger
JT/T 1325 Technical specification and test method for travelling temperature
recorder
WB/T 1097 General specification for cold-chain insulated container of drug
WB/T 1104 Road transport - Requirements of refrigerated vehicle functions for
pharmaceutical products
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 audit
The process in which the pharmaceutical logistics quality management auditor checks
to determine whether the quality management of pharmaceutical logistics service
providers meets the audit content and forms documents.
[Source: GB/T 19011-2021, 3.1, modified]
3.2 pharmaceutical logistics quality management auditor
A legal person organization that implements pharmaceutical logistics quality
management audit work.
NOTE: It includes pharmaceutical logistics service entrusting parties, quality management full-time
audit institutions, etc.
4 Basic requirements for auditors
4.1 An audit management system of pharmaceutical logistics quality management shall
be established.
4.2 Quality management personnel with quality management audit capabilities shall be
had.
4.3 The audit materials and related information provided by the pharmaceutical logistics
service provider shall be kept confidential.
5 Audit work requirements
5.1 The pharmaceutical logistics service entrusting party shall audit the service quality
management and other aspects of the pharmaceutical logistics service provider when
they cooperate for the first time, during the cooperation period, and when the
pharmaceutical logistics service provider undergoes major changes. The frequency of
audits during the cooperation period shall comply with relevant regulations.
5.2 The corresponding service quality management audit work plan shall be formulated
according to the business model of the pharmaceutical logistics service provider and
the types of business it undertakes, and the audit work plan shall be informed to the
pharmaceutical logistics service provider in advance.
5.3 The audit work plan shall include but is not limited to the name of the
pharmaceutical logistics service provider, audit time, audit location, audit type and
method, audit purpose, audit basis, audit scope, audit team members, audit
implementation process, audit content, and the list of audit materials required to be
and improved for suitability and effectiveness.
6.2.3 For personnel and training, the following contents shall be audited.
a) The suitability of the staffing to the type of business to be undertaken. Whether
the personnel in the key positions have no experience of job forbidden.
NOTE: Personnel in key positions include quality management personnel, personnel in
positions directly in contact with drugs, etc.
b) Whether the relevant operators of cold chain drugs have passed the assessment
before starting to work. Whether transport drivers and forklift operators have
obtained certificates for operations.
c) The pre-employment and annual health checks of personnel directly in contact
with pharmaceuticals, and the establishment of employee health management
files. Whether the person suffering from an infectious disease or other diseases
that may contaminate the drug is not engaged in work that directly contacts
the drug.
d) The formulation and approval of the annual training plan and whether the
training is carried out according to the plan.
e) Implementation of pre-employment and regular training for personnel in each
position in terms of job responsibilities and job content; whether the training
contents include but are not limited to laws and regulations, professional
knowledge, job responsibilities, etc.
f) Whether the training archives include training records, photos, videos,
assessment materials, and other documents.
6.2.4 For facilities and equipment, the warehouses, vehicles, refrigerators or incubators,
temperature recorders, information systems, etc. shall be audited, and the specific
requirements are as follows.
a) For the warehouse, the following contents shall be audited:
1) Whether the site selection, design, layout, construction, renovation, and
maintenance of the warehouse meet the storage requirements for
pharmaceutical products;
2) Whether it is equipped with equipment that meets the storage
requirements of pharmaceutical products;
Example: Facilities and equipment that are used for light-proof, ventilation, moisture-
proof, insect-proof, rodent-proof, bulk picking, and LCL delivery operations and review.
3) Whether there are work places for receipt and delivery, acceptance
inspection, storage, return, storage of packaging materials, storage of
unqualified pharmaceutical products, etc.;
4) When cold chain pharmaceutical products are stored, whether the cold
storage complies with the provisions of the relevant chapters of GB/T
28842.
b) For the vehicle, the following contents shall be audited:
1) Whether the compartment is closed and whether the refrigerated vehicle
meets the requirements of WB/T 1104;
2) Whether it is equipped with a global positioning system or other
monitoring system.
c) For the refrigerator or incubator, the following contents shall be audited:
1) Whether it is equipped with temperature monitoring equipment;
2) Whether the incubator complies with the regulations of WB/T 1097.
d) For the temperature recorder, the following contents shall be audited:
1) Whether it complies with the provisions of GB/T 35145 and JT/T 1325;
2) Whether the calibration or verification is carried out regularly every year.
e) For the information system, the following contents shall be audited:
1) Whether it is equipped with a computer information system that can
operate independently and meet the requirements of the whole process and
quality management of pharmaceutical logistics operation, and can
implement the data exchange of the whole process of logistics and the
product traceability and traceable management with the pharmaceutical
logistics service entrusting party;
2) Whether the data entry, modification, storage, and other operations
comply with the scope of authorization, operating procedures, and
management system requirements, and whether the data is original,
authentic, accurate, safe, and traceable;
3) Whether the data storage is safe, reliable, and backed up on a daily basis,
and whether the backup data is stored in a safe place;
4) Whether it is equipped with a temperature and humidity monitoring
system capable of real-time automatic monitoring and recording functions,
a) The formulation of the internal audit inspection system and internal audit
inspection plan, and the record of the internal audit process;
b) Whether the internal audit is carried out regularly or when there are major
changes in the key elements of the quality management system, and whether
the internal audit situation is analyzed and corresponding improvement
measures are formulated.
6.2.9 For the emergency management, the following contents shall be audited:
a) The formulation of the emergency plan management mechanism, the
formulation of emergency plans for possible power outages, equipment
failures, traffic accidents, natural disasters, transportation delays, and other
emergencies;
b) Whether the emergency plan includes emergency organization, personnel
responsibilities, facilities and equipment, external collaboration resources,
response time, emergency measures, etc., and whether the emergency plan is
regularly drilled.
7 Audit judgment
Pharmaceutical logistics quality management auditors can conduct the audit judgment
on Chapter 6 according to GB/T 28842, GB/T 30335, GB/T 34399, GB/T 35145, JT/T
1325, WB/T 1097, WB/T 1104, or higher standards.
8 Audit results and feedback
8.1 The pharmaceutical logistics quality management auditor shall issue an audit report.
The audit report shall include but be not limited to the name of the pharmaceutical
logistics service provider, audit time, audit location, audit type and method, audit
purpose, audit basis, audit scope, audit team members, audit implementation process,
audit contents, audit results, etc.
8.2 When necessary, the pharmaceutical logistics quality management auditor shall
notify the pharmaceutical logistics service provider to formulate relevant corrective
measures based on the audit results, and check and confirm the corrective results.
9 Evaluation and improvement
9.1 The pharmaceutical logistics quality management auditor shall regularly evaluate
the audit work.
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