ISPE 指南：生物制药工艺开发与生产 ISPE Guide Biopharmaceutical Process Development and Manufacturing

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Appendix 1 Biopharmaceutical Process Development and Manufacturing

9 Appendix 1 – Non-US Manufacturing and Non-FDA Regulated

Market Requirements

9.1 Introduction

For any safety, environmental and engineering legislation and guidelines referenced, the laws and guidelines in the

country in which the development or manufacturing operation is taking place will apply.

9.2 Occupational Health and Safety Regulatory Organizations and Standards

Occupational Health and Safety is regulated by the country in which the research or manufacturing activity is taking

place. Rather than listing all such national regulatory agencies here, some examples are given along with details

of some important harmonization initiatives across countries through international government agencies or non-

governmental organizations and standards committees.

In the US the National Institutes of Health (NIH) Guidelines for Research involving Recombinant DNA, Molecules

(US NIH Guidelines) [97] are normally applied to establishing biosafety measures, and these Guidelines are

supplemented by information developed by a number of other important organizations (such as Tradeline Inc.) and

guidelines (such as Guidelines for Process Safety in Bioprocess Manufacturing Facilities from the American Institute

of Chemical Engineers (AIChemE).

On a global basis, with regard to biosafety, the WHO publishes guidance for biosafety. This guidance is frequently in

use where specic legislation for biosafety has not been put in place in a given country. This guidance includes:

• WHO Laboratory Biosafety Manual – Third Edition [101]

The WHO also publishes regular guidance through their Global Alert and Response (GAR) program on specic

diseases which is particularly important to monitor when dening processes containing live viruses (such as used in

the Flu vaccine).

The WHO also operates a Biosafety Advisory Group (BAG) to support their global biosafety and laboratory biosecurity

program.

The International Federation of Biosafety Associations (IFBA) is promoting collaboration and possible long term

harmonization of standards between the various national and regional biosafety organizations. Various international

biosafety organizations are listed on their website, along with access to various international guidelines in PDF format

[102].

Additionally the International Biosafety Working Group which comprises members from a number of international

biosafety organizations publishes a document entitled “Biosafety Compendium on Regulations, Guidelines and

Information Sources” [103] which is a useful industry Guideline.

Another international committee is the International Veterinary Biosafety Working Group which focuses on veterinary

laboratories operating at biosafety level 3 or higher.

9.2.1 Europe

The pan European organization for occupational health and safety is the European Agency for Health and Safety at

Work [104]. Safety legislation is often rst enacted at a European level (e.g., CE Marking legislation and ATmosphere

EXplosibles (ATEX) legislation).

This Document is licensed to

Dr. George Nabil Samy Mohareb

Nasr City, Cairo,

ID number: 1066188

Downloaded on: 2/15/22 3:27 PM

ISPE Guide: Page 137

Biopharmaceutical Process Development and Manufacturing Appendix 1

However, the legislation is then also enacted at a national level, and each country can decide to set additional

requirements above the minimum European requirements, and the requirements at national level should be checked,

as well as referring to European law.

To enact the occupational health and safety legislation each country within Europe has its own national organisation

for occupational health and safety, for example:

• France: Institut National de Recherche et de Securite (INRS)

• Germany: Technischer Überwachungsverein (TUEV)

• Ireland: Health and Safety Authority (HSA)

• Switzerland: Schweizerische Unfallversicherungsanstalt (SUVA)

• United Kingdom: Health and Safety Executive (HSE)

Information on the relevant required national legislation to be complied with may be found on the websites of the

national organizations.

With regard to Biosafety, there are a number of important organisations with Europe, some of which are departments

within the national health and safety organisation, others which are non-governmental organizations, including:

• Europe: European Biosafety Organisation (EBSA)

• Netherlands: Biosafety Ofcers Association

• United Kingdom: Advisory Committee on Dangerous Pathogens (ACDP)

9.2.2 Asia,Australia,andPacicRegionRegulatoryAuthorities

In Asia the safety legislation is enacted at a national level and enforced by the relevant national and state

organizations, for example:

• China: Ministry of Health

• India: Ministry of Labour and Employment, The Directorate General, Factory Advice Service & Labour Institutes

(DGFASLI)

• Japan: The Ministry of Health, Labour and Welfare (MHLW)

With regard to biologics and biosafety, there are a number of important government organizations within each country

which must be considered, so for example (the following lists are not exhaustive for each Country):

• China:

- Beijing Municipal Health Bureau

- Institute of Occupational Health and Poisoning (Chinese Centre of Disease Control and Prevention (CCDC))

- Beijing Institute of Occupational Health

- Beijing Centre of Diseases Control and Prevention (BCDC)

This Document is licensed to

Dr. George Nabil Samy Mohareb

Nasr City, Cairo,

ID number: 1066188

Downloaded on: 2/15/22 3:27 PM

Page 138 ISPE Guide:

Appendix 1 Biopharmaceutical Process Development and Manufacturing

- Bureau of Health in Districts and Counties

- Departments of Occupational Health in Centre of Disease Control (CDC) centers in Districts and Counties

• India:

- Department of Biotechnology. Ministry of Science and Technology

- Recombinant DNA Advisory Committee (RDAC)

- Review Committee on Genetic Manipulation (RCGM)

- Institutional Biosafety Committee (IBSC)

- Genetic Engineering Appraisal Committee (GEAC)

- State Biotechnology Coordination Committee (SBCC)

• Australia:

- Standards Australia (which publishes AS/NZS 2243.3:2002 Safety in laboratories – Microbiological aspects

and containment facilities [105])

In Japan the MHLW legislated the bio-safety Guideline on 14 February 2000. The guideline referred to WHO

“Biosafety Guidelines for Personnel Engaged in the Production of Vaccines and Biological Products for Medical Use”

[106] and “Laboratory Biosafety Manual – Third Edition” [101].

There is also a pan Asian-Pacic organization called Asia-Pacic Biosafety Association looking at biosafety issues

across the region

9.2.3 Americas

In the Americas, the safety legislation is enacted at a national level and enforced by the relevant national and state

organizations, e.g.:

• Brazil: Ministry of Labour and Employment

• Canada: Public Health Agency of Canada

• Uruguay: Ministry of Labour and Social Security

With regard to biologics and biosafety, there are a number of important organizations which include, e.g.:

• Brazil: Comissão Técnica Nacional de Biossegurança (CTNBio)

• Brazil: Associação Nacional de Biossegurança (ANBio)

• Canada: Ofce of Laboratory Security (OLS), Health Canada

• Canada: Canadian afliate of the American Biological Safety Association (ABSA)

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本页面详细介绍《ISPE 指南：生物制药工艺开发与生产》（ISPE Guide Biopharmaceutical Process Development and Manufacturing）的核心内容与应用价值。该指南由国际制药工程协会（ISPE）发布，专注于生物制药从细胞培养、纯化工艺到商业化生产的全流程技术规范与最佳实践。内容涵盖工艺验证、一次性使用系统、质量源于设计（QbD）、工艺表征与控制策略等关键议题，旨在帮助制药企业提升研发效率、确保产品质量一致性，并符合全球监管要求。无论是从事早

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ISPE 指南：生物制药工艺开发与生产 ISPE Guide Biopharmaceutical Process Development and Manufacturing

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