How Long to Read The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals

How Long Does it Take to Read The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals?

It takes the average reader 6 hours and 45 minutes to read The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals by José Rodríguez-Pérez

Assuming a reading speed of 250 words per minute. Learn more

Description

This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.

How long is The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals?

The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals by José Rodríguez-Pérez is 396 pages long, and a total of 101,376 words.

This makes it 134% the length of the average book. It also has 124% more words than the average book.

How Long Does it Take to Read The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals Aloud?

The average oral reading speed is 183 words per minute. This means it takes 9 hours and 13 minutes to read The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals aloud.

What Reading Level is The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals?

The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals is suitable for students ages 12 and up.

Note that there may be other factors that effect this rating besides length that are not factored in on this page. This may include things like complex language or sensitive topics not suitable for students of certain ages.

When deciding what to show young students always use your best judgement and consult a professional.

Where Can I Buy The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals?

The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals by José Rodríguez-Pérez is sold by several retailers and bookshops. However, Read Time works with Amazon to provide an easier way to purchase books.

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