GB/T 28671-2012 English PDF

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GB/T 28671-2012: Guidelines for pharmaceutical machinery validation
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 28671-2012	1129	Add to Cart	8 days	Guidelines for pharmaceutical machinery validation	Valid

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Basic data

Standard ID: GB/T 28671-2012 (GB/T28671-2012)
Description (Translated English): Guidelines for pharmaceutical machinery validation
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C90
Classification of International Standard: 11.120
Word Count Estimation: 51,587
Quoted Standard: GB 28670-2012; TSG R0004-2009; pharmaceutical production and quality management standards (revised 2010)Ministry of Health in January 2011 Decree No. 79
Regulation (derived from): National Standards Bulletin No. 24 of 2012
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary: This standard specifies the pharmaceutical machinery (equipment) verify the terms and definitions, validation purposes, principles, procedures and programs. This standard applies to guide pharmaceutical equipment design validation, installation confirmati

GB/T 28671-2012: Guidelines for pharmaceutical machinery validation

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS11.120 C90 National Standards of People's Republic of China Pharmaceutical Machinery (equipment) Verification Guidelines Issued on. 2012-09-03 2013-07-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Table of Contents

Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Verify 2 4.1 authentication purposes 2 4.2 Principle 2 verification 4.3 Verification Program 2 4.4 authentication scheme 3 4.5 fabricating provide relevant technical information 5 Appendix A (informative) design validation scheme Example 6 Annex B (informative) Installation Qualification program example 18 Annex C (informative) run exemplary acknowledgment scheme 29 Annex D (informative) Example 39 Performance verification scheme

Foreword

Rules of the standard in accordance with the "Good Manufacturing Practice (revised 2010)," the relevant requirements and GB/T 1.1-2009 given Drafted. This standard by the National Pharmaceutical Equipment Standardization Technical Committee (SAC/TC356) and focal points. This standard is drafted by. Intertek Shanghai Pharmaceutical Machinery Co., Ltd Taiwan Jian, China Pharmaceutical Equipment Industry Association. Participated in the drafting of this standard. Shanghai Asia Pioneer Pharmaceutical Co., Ltd., Shanghai Far East Pharmaceutical Machinery Co., Ltd., Shanghai Polytechnic University. The main drafters of this standard. Chen Lu true, Tian Yaohua, high-dimensional, Chen Lan, Li Huaqiang. Pharmaceutical Machinery (equipment) Verification Guidelines

1 Scope

This standard specifies the Pharmaceutical Machinery (equipment) (hereinafter referred to as pharmaceutical equipment) verification of terms and definitions, validation purposes, principles, procedures and Program. This standard applies to guide pharmaceutical equipment design validation, installation, OQ and performance qualification verification and other work.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated edition applies to this article Member. For undated references, the latest edition (including any amendments) applies to this document. GB 28670-2012 Pharmaceutical Machinery (equipment) General implementation of Good Manufacturing Practices TSGR0004-2009 Fixed Supervision Regulations (the State Administration of Quality Supervision, Inspection and Quarantine and Pressure Vessel Safety Technology 2009 Announcement No. 83) Good Manufacturing Practice (revised 2010) (People's Republic of China Ministry of Health, 79 January 2011 Decree)

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Pharmaceutical equipment verification pharmaceuticalequipmentvalidation Pharmaceutical equipment design validation, installation, OQ and performance qualification, proven pharmaceutical equipment to achieve the expected result of a A series of activities. 3.2 User needs standard userrequirementspecification While meeting the relevant regulations and standards, consumer equipment to meet the requirements of the target document production, inspection and management of the conditions required. 3.3 Authentication scheme validationprotocol It explains how to verify and validate the eligibility criteria to determine the written plan, which includes verification of objectives, contents, methods and acceptance criteria. 3.4 Design validation designqualification Pre-review of pharmaceutical equipment, pharmaceutical equipment designed to meet the proof of intended use, "Good Manufacturing Practice (Revised 2010 Order) "and Appendix, standard user needs and pharmaceutical equipment product standards. 3.5 Installation Qualification instalationqualification Pharmaceutical equipment after installation of various systems checks, proof of pharmaceutical equipment manufacture and installation of the required standard. 3.6 OQ operationalqualification Various operational tests to verify the equipment or associated with the pharmaceutical system reaches the set requirements be proved run pharmaceutical equipment operator Co-design standards. ......

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