GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)

The United States Code of Federal Regulations 21 CFR, Sections 1301–1307, Requirements for Controlled Drug Substances

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) ◽

10.3109/9780203026656-9 ◽

2004 ◽

pp. 99-185

Keyword(s):

United States ◽

The United States ◽

Federal Regulations ◽

Drug Substances ◽

United States Code

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The United States Food and Drug Administration and ICH Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) ◽

10.3109/9780203026656-8 ◽

2004 ◽

pp. 57-97

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Good Manufacturing Practice ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients ◽

United States Food ◽

States Food

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The United States Code of Federal Regulations 21 CFR, Sections 803.17 and 803.18 for Medical Device Reporting

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) ◽

10.3109/9780203026656-3 ◽

2004 ◽

pp. 7-8

Keyword(s):

United States ◽

Medical Device ◽

The United States ◽

Federal Regulations ◽

United States Code

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International Organization for Standardization ISO 19011 Guidelines for Quality and/or Environmental Management Systems Auditing

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) ◽

10.3109/9780203026656-19 ◽

2004 ◽

pp. 417-446

Keyword(s):

Environmental Management ◽

International Organization ◽

Management Systems ◽

Environmental Management Systems ◽

International Organization For Standardization ◽

Iso 19011

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International Organization for Standardization ISO 9000-3, Guidelines for the Application of ISO 9001:1994 to the Development, Supply, Installation and Maintenance of Computer Software

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) ◽

10.3109/9780203026656-13 ◽

2004 ◽

pp. 279-314

Keyword(s):

Computer Software ◽

Iso 9000 ◽

International Organization ◽

Iso 9001 ◽

International Organization For Standardization

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The United States Code of Federal Regulations 21 CFR, Part 11, Electronic Records/Electronic Signatures

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) ◽

10.3109/9780203026656-2 ◽

2004 ◽

pp. 1-5

Keyword(s):

United States ◽

The United States ◽

Electronic Records ◽

Federal Regulations ◽

Electronic Signatures ◽

United States Code

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The European Community (EC) Guide to Good Manufacturing Practices for Medicinal Products, including Annexes 1 and 15

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) ◽

10.3109/9780203026656-12 ◽

2004 ◽

pp. 221-277

Keyword(s):

European Community ◽

Medicinal Products ◽

Good Manufacturing Practices

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The United States Military Standard–790F, Standard Practice for Established Reliability and High Reliability Qualified Products List (QPL) Systems for Electrical, Electronic and Fiber Optic Parts Specifications

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) ◽

10.3109/9780203026656-11 ◽

2004 ◽

pp. 201-219

Keyword(s):

United States ◽

Fiber Optic ◽

High Reliability ◽

The United States ◽

United States Military ◽

Standard Practice

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The United States Code of Federal Regulations 21 CFR, Section 820, Quality System Regulation (QSR), Current Good Manufacturing Practices (CGMP) Requirements for Medical Devices

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) ◽

10.3109/9780203026656-6 ◽

2004 ◽

pp. 13-29

Keyword(s):

United States ◽

Medical Devices ◽

The United States ◽

Quality System ◽

Federal Regulations ◽

Good Manufacturing Practices ◽

United States Code

Download Full-text

International Organization for Standardization ISO 13485 Quality Systems — Medical Devices — Particular Requirements for the Application of ISO 9001

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) ◽

10.3109/9780203026656-16 ◽

2004 ◽

pp. 359-370

Keyword(s):

Medical Devices ◽

International Organization ◽

Iso 9001 ◽

Quality Systems ◽

International Organization For Standardization

Download Full-text

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)
Latest Publications

TOTAL DOCUMENTS

H-INDEX

Published By CRC Press

The United States Code of Federal Regulations 21 CFR, Sections 1301–1307, Requirements for Controlled Drug Substances

The United States Food and Drug Administration and ICH Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

The United States Code of Federal Regulations 21 CFR, Sections 803.17 and 803.18 for Medical Device Reporting

International Organization for Standardization ISO 19011 Guidelines for Quality and/or Environmental Management Systems Auditing

International Organization for Standardization ISO 9000-3, Guidelines for the Application of ISO 9001:1994 to the Development, Supply, Installation and Maintenance of Computer Software

The United States Code of Federal Regulations 21 CFR, Part 11, Electronic Records/Electronic Signatures

The European Community (EC) Guide to Good Manufacturing Practices for Medicinal Products, including Annexes 1 and 15

The United States Military Standard–790F, Standard Practice for Established Reliability and High Reliability Qualified Products List (QPL) Systems for Electrical, Electronic and Fiber Optic Parts Specifications

The United States Code of Federal Regulations 21 CFR, Section 820, Quality System Regulation (QSR), Current Good Manufacturing Practices (CGMP) Requirements for Medical Devices

International Organization for Standardization ISO 13485 Quality Systems — Medical Devices — Particular Requirements for the Application of ISO 9001

Export Citation Format

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)Latest Publications

TOTAL DOCUMENTS

H-INDEX

Published By CRC Press

The United States Code of Federal Regulations 21 CFR, Sections 1301–1307, Requirements for Controlled Drug Substances

The United States Food and Drug Administration and ICH Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

The United States Code of Federal Regulations 21 CFR, Sections 803.17 and 803.18 for Medical Device Reporting

International Organization for Standardization ISO 19011 Guidelines for Quality and/or Environmental Management Systems Auditing

International Organization for Standardization ISO 9000-3, Guidelines for the Application of ISO 9001:1994 to the Development, Supply, Installation and Maintenance of Computer Software

The United States Code of Federal Regulations 21 CFR, Part 11, Electronic Records/Electronic Signatures

The European Community (EC) Guide to Good Manufacturing Practices for Medicinal Products, including Annexes 1 and 15

The United States Military Standard–790F, Standard Practice for Established Reliability and High Reliability Qualified Products List (QPL) Systems for Electrical, Electronic and Fiber Optic Parts Specifications

The United States Code of Federal Regulations 21 CFR, Section 820, Quality System Regulation (QSR), Current Good Manufacturing Practices (CGMP) Requirements for Medical Devices

International Organization for Standardization ISO 13485 Quality Systems — Medical Devices — Particular Requirements for the Application of ISO 9001

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)
Latest Publications