GB/T 36988-2018Guidance for good tissue practice of human origin for tissue engineered medical products (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

As a multidisciplinary and emerging field, tissue engineering has developed rapidly in the past two decades, bringing revolutionary innovation to traditional medicine. New, playing an irreplaceable role in the field of regenerative medicine. The US Food and Drug Administration (FDA) has approved tissue engineered skin Nearly 10 products such as cartilage are on the market. The State Food and Drug Administration (CFDA) also approved the listing of tissue engineering skin. organization The industrialization of engineering medical products has begun to take shape. After nearly two decades of development, China's tissue engineering technology research is close to the international advanced level.

In some areas, even in the international leading position, the research of technical standards is gradually being built.

Human cells and tissues are one of the basic units of tissue engineering products. Compared with other countries, China is marking human cells and tissues. Quasi-construction is even weaker, as the US FDA issued in 2004 on human cells and tissues and based on cell organization. Federal regulations for products (21CFR1271HumanCels, Tissues, and CelalandTissue-basedProducts), of which Part C (DopartC-DonorEligibility) specifies the human donor qualification requirements, Part D (SubpartD-CurrentGood) TissuePractice) specifies good tissue practices for human cells, tissues and related products. Japan issued a treatment in 2000 And guidelines for using cell tissue products (GeneralPrinciplesfortheHandlingandUseofCelular/T issue-basedProducts), in 2008, issued guidelines to ensure the quality and safety of human cells, tissue products (Guidelineson EnsuringQualityandSafetyofHumanCel/T issue-processedProducts). Australia was enacted in 2000 Codeofgood manufacturing process-human blood and tissue, in Good practice guidelines for human blood, blood components, human tissue and cell therapy products were issued in May.2013 (Codeofgoodmanufac- Turingpracticeforhumanbloodandbloodcomponents,humantissueandhumanceluartherapyprod- Ucts). In 2007, China published guidelines related to the processing of cells, tissues and organs that were not equivalent to ASTM standards.

This guideline contains the principle requirements for cells, tissues and organs of the same and heterogeneous origin, not just for human cells and tissues.

As a result, some specific categories of organizational product standards also stipulate relevant requirements, but still show insufficient versatility. So far, There is still a lack of versatility in the assessment of human donor qualifications, cell and tissue manipulation practices, and evaluation of cell-containing tissue engineering products. Related standards.

In order to further standardize and promote the development of China's tissue engineering products industry, it is based on the management model of China's pharmaceuticals and medical devices. The status of research and development and production of tissue engineering products in China, the contents of internationally existing cell and tissue operating practices and ISO related guidelines As a blueprint, this standard is formulated in conjunction with the relevant requirements of China's pharmaceutical and medical device production quality management standards. Not only for the production of enterprise products Provide guidance for production and quality management, provide technical support for regulatory authorities to formulate laws and regulations, and clinical transformation and promotion of tissue engineering in China The process of industrialization development will be of great significance.

1 Scope

This standard specifies the requirements for human cells, tissues and cell-based, tissue-based products (HCT/Ps) in all aspects of production. Including the establishment of quality systems, facilities, cell and tissue collection, processing, product preservation and transportation, recalls and donor qualification assessment.

This standard applies to the production of human cells, tissues or products based on cells and tissues for tissue engineering. This standard does not apply For organ transplantation and germ cell manipulation.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB 18279.1-2015 Sterilization of ethylene oxide for health care products - Part 1: Development, validation and General control requirements

GB 18280.1-2015 Sterilizing radiation for health care products - Part 1: Development, validation and routine Control requirements

YY0033 Sterile medical device production management specification

YY/T 0606.16 Tissue Engineering Medical Products Part 16: Preservation Guide

YY/T 1445-2016 Tissue Engineering Medical Device Product Terminology

ISO 13408-1:2008 Aseptic processing of health care products - Part 1. General requirements (Aseptic processing of health careproducts-Part 1: Generalrequirements)

ISO 13408-7:2012 Aseptic treatment of health care products - Part 7. Replacement processing of medical devices and combination products (A- septicprocessingofhealthcareproducts-Part 7: Alternativeprocessesformedicaldevicesandcombi- Nationproducts)

ISO 14160:2011 Health Products Sterilization of disposable medical devices using animal tissues and their derivatives Characterization, development, validation and routine control requirements for the sterilization process of therapeutic devices (Sterilization of health care products-Liquid Chemicalsterilizingagentsforsingle-usemedicaldevicesutilizinganimaltissuesandtheirderivatives-Re- Requirements for characterization,development,validationandroutinecontrolofasterilizationprocess Formalicaldevices)

ISO 14937:2000 Development, verification and routine control of the characteristics and disinfection methods of disinfectants for medical devices General requirements for the system (Sterilizationofhealthcareproducts-Generalrequirementsfor characterizationofa Sterilingagentandthedevelopment,validationandroutinecontrolofasterilizationprocessformedi- Caldevices)

ISO 17665-1:2006 Sterilization of health products - Heating in humid air - Part 1. Development and validation of medical equipment Sterilization process and requirements for its routine control (Sterilization of health care products-Moistheat-Part 1. Re- Requirementsforthedevelopment,validationandroutinecontrolofasterilizationprocessformedicalde- Vices)

ISO 18362:2016 Control of microbial risk during manufacturing and processing of cell-based health care products (Manufactureof cel-basedhealthcareproducts-Controlofmicrobialrisksduringprocessing)

ISO 20857:2010 Requirements for the setting, validation and routine control of sterilization processes for sterilized dry heat medical devices