GB/T 22275.5-2008Requirements of conduct for Good Laboratory Practice (GLP) -- Part 5: The application of the GLP principles to short term studies (English PDF)
良好实验室规范实施要求 第5部分：良好实验室规范原则在短期研究中的应用
This is a limited preview
Buy now to download the full PDF (6 pages)
Need quotation for your management?
Get a formal quotation for GB/T 22275.5-2008 in 30 minutes.
Issued by
Standardization Administration of China
Level / Type
National · Recommended
Issue date
August 4, 2008
Implementation date
April 1, 2009
Scope
GB/T 22275.5-2008 is the English-translated version of 良好实验室规范实施要求 第5部分：良好实验室规范原则在短期研究中的应用.
GB/T 22275.5-2008 — This section GB/T 22275 specifies the organization and personnel of short-term studies of the testing facility, quality assurance programs, facilities, test system, Test samples and reference standard operating procedures, implementation and research results of the study report.
Except as expressly exempted national legislation, good laboratory provided for in this part of the normative principles (hereinafter referred to as GLP principles) applicable laws and regulations all non-clinical health and environmental safety studies required, including pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and Similar product registration or application for a permit, as well as industrial chemicals management.
Found what you need?
Document preview — GB/T 22275.5-2008
National Standard of the People's Republic of China
- ICS
- 03.120.20
- Classification
- A 00
Issued by: Standardization Administration of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Main technical specifications
- 4.1 Test organization and personnel agencies
- 4.2 Quality Assurance Plan
Foreword
GB/T 22275 "to implement the requirements of Good Laboratory Practice" is divided into seven sections.
--- Part 1. Quality Assurance and Good Laboratory Practice;
--- Part 2. Good Laboratory Practice Research project leader roles and responsibilities;
--- Part 3. Laboratory Supplier of Good Laboratory Practice Principles compliance;
--- Part 4. Good Laboratory Practice principles in the field of applied research;
--- Part 5. Application of the principles of Good Laboratory Practice in short term studies;
--- Part 6. Application of the principles of Good Laboratory Practice in the computerized system;
--- Part 7. application of the principles of good laboratory practice in the organization and management of multi-site studies.
This section GB/T 22275 Part 5.
This section is equivalent to using the Organisation for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and a series of documents for compliance monitoring no. 7. "GLP principles in short-term studies in the application" [ENV/JM/MONO (99) 23].
This part made the following editorial changes.
--- Remove the foreword, introduction and catalog parts.
This part of the National Chemicals Management Standardization Technical Committee dangerous (SAC/TC251) and focal points.
The drafting of this section. Shandong CIQ.
1 Scope
This section GB/T 22275 specifies the organization and personnel of short-term studies of the testing facility, quality assurance programs, facilities, test system, Test samples and reference standard operating procedures, implementation and research results of the study report.
Except as expressly exempted national legislation, good laboratory provided for in this part of the normative principles (hereinafter referred to as GLP principles) applicable laws and regulations all non-clinical health and environmental safety studies required, including pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and Similar product registration or application for a permit, as well as industrial chemicals management.
2 Normative references
The following documents contain provisions which, through reference GB/T 22275 in this section constitute provisions of this section. For dated references, all subsequent amendments (excluding corrections) or revisions do not apply to this section, however, encourage an agreement under this section Parties to study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.
GB/T 22275.1 good laboratory practice - Part 1. Quality Assurance and Good Laboratory Practice GB/T 22278-2008 principles of Good Laboratory Practice
3 Terms and Definitions
GB/T 22278-2008 The terms and definitions apply to this part of the GB/T 22275 of.
4 Main technical specifications
4.1 Test organization and personnel agencies
Responsibilities 4.1.1 testing facility managers shall ensure that each study before start specified by the administrator with the appropriate qualifications, training and experience of the staff as a project manager. Negative items the person in charge should be replaced and documented in accordance with established procedures.
Note. The project leader is designated to ensure that research is a key factor in the proper planning, execution and reporting. Suitably qualified person in charge of the project depends more on experience rather than education.
4.2 Quality Assurance Plan
4.2.1 General
Test body should have a written quality assurance program to ensure the implementation of the study followed the principles of GLP.
Note 1. The "quality assurance program" should be mentioned in this standard reference GB/T 22278-2008 and GB/T 22275.1 explained. For the physical - chemical research Studies, other published standards (such as ISO 9000 series) for "quality assurance" This definition is different.
Note 2. The quality assurance program shall include file-based research, facilities-based, process-based inspection description GB/T 22275.1 defined by. These settings Defined as follows.
--- Check-based research. this type of inspection in accordance with the progress of the study to arrange the examination schedule, usually first determine the critical phase of the study;
--- Check-based infrastructures. This type of inspection is not based on specific research, but covers general facilities and activities within a laboratory (Ann Equipment, support services, computer systems, training, environmental monitoring, maintenance and calibration, etc.);
--- Check-based process. This type of examination has nothing to do with a particular study. They are used to monitor the program or process having repetitive nature, usually
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 6 pages — is available in the English PDF.
Referenced standards
How to Download GB/T 22275.5-2008
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 22275.1-2008 — Requirements of conduct for Good Laboratory Practice (GLP) -- Part 1: Quality assurance and GLP
GB/T 22275.2-2008 — Requirements of conduct for Good Laboratory Practice (GLP) -- Part 2: The role and responsibilities of the study director in GLP studies
GB/T 22275.3-2008 — Requirements of conduct for Good Laboratory Practice (GLP) -- Part 3: Compliance of laboratory suppliers with GLP principles
Secure payment via Stripe
Payments accepted
GB/T 22275.5-2008
$85.00