How To Develop And Manage Qualification Protocols For Fda Compliance
by Phil Cloud /
1999 / English / PDF
12.5 MB Download
All current Good Manufacturing Practices (cGMP), Good Clinical
Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000
standards and regulations require that validation document be
established and followed. Yet these regulations do not provide
guidelines on how to produce documentation such as qualification
protocols.
All current Good Manufacturing Practices (cGMP), Good Clinical
Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000
standards and regulations require that validation document be
established and followed. Yet these regulations do not provide
guidelines on how to produce documentation such as qualification
protocols.
How to Develop and Manage Qualification Protocols for FDA
Compliance focuses specifically on the FDA documentation
requirements, providing concrete guidance on how to develop and
manage qualification protocols and their associated documentation
to ensure your company is not at risk.
How to Develop and Manage Qualification Protocols for FDA
Compliance focuses specifically on the FDA documentation
requirements, providing concrete guidance on how to develop and
manage qualification protocols and their associated documentation
to ensure your company is not at risk.
Key function areas, such as cleaning, facilities and utilities,
equipment, computers and software, and process are discussed in
detail. The book contains 35 validation procedures and 30 forms
that can be used to establish a validation documentation system and
provides protocol templates you can use as your own. Numerous
diagrams and graphics are used to illustrate key points.
Key function areas, such as cleaning, facilities and utilities,
equipment, computers and software, and process are discussed in
detail. The book contains 35 validation procedures and 30 forms
that can be used to establish a validation documentation system and
provides protocol templates you can use as your own. Numerous
diagrams and graphics are used to illustrate key points.
Most importantly, this book will provides hands-on, "been there"
advice on how to:
Most importantly, this book will provides hands-on, "been there"
advice on how to:Write protocols and final reports
Write protocols and final reportsDevelop protocol formats and style guides
Develop protocol formats and style guidesEstablish a documentation review and approval system
Establish a documentation review and approval systemImplement document control and forms control programs
Implement document control and forms control programsMigrate your documentation system from paper to electronic
format
Migrate your documentation system from paper to electronic
format
If your responsibilities include writing and managing
qualification protocols for drug products and related
industries, here's all you need to build a cost-effective,
manageable--and compliant--system.
If your responsibilities include writing and managing
qualification protocols for drug products and related
industries, here's all you need to build a cost-effective,
manageable--and compliant--system.
