Title: Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing (eng)
Publisher: Wiley
Publication Date: 2020
Language: English
ISBN 10: 1119356075
ISBN 13: 9781119356073
Binding: Hardcover
Condition: new
Weight: 1.04 kilograms

About this title

Synopsis

Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals.

Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC
Presents the latest developments in both regulatory expectations and technical advancements
Provides guidance on statistical tools for risk assessment and trending of microbiological data
Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

About the Author

David Roesti, PhD, works at Novartis Pharma AG in Stein, Switzerland, and is responsible for defining the microbial control strategy at the site and is a global subject matter expert in microbiology for the Novartis group. He is also is an elected member of the General Chapters Microbiology Expert Committee of the Unites States Pharmacopoeia 2015�2020 revision cycle.

Marcel Goverde, PhD, runs MGP Consulting GmbH for consulting, training and project management in GMP-relevant areas with a focus on microbiology, hygiene and deviation management. He is the Swiss expert in the EDQM group for Modern Microbiological Methods since 2003, which was then integrated into Group 1 (Microbiological Methods and Statistical Analysis) in 2015.

"About this title" may belong to another edition of this title.

Store Description

Account dedicated to Print on Demand titles. Brook Bookstore offers a wide selection of books with a continuously updated catalog and fast shipments all over the world. We hold distribution rights with all of the publishers we promote and are in continuous search of new interesting titles to propose to our customers. We are part of Brandon Group SRL (an Italian company) and all of the orders are shipped from Europe. Depending on availability orders will be picked from our different warehouses. CONTACT US If you have any questions please do not hesitate to contact us sending a message to our store. We have a well prepared customer service team who will be happy to assist you. Our working hours are from Monday to Friday from 9:30 to 18:30 (CET, UTC +1) so messages received during the weekends might be responded with a slight delay but we guarantee you will get back to you as soon as possible. RETURNS If you want to return your order, please submit your request through Abebooks platform. Returns requests are managed case by case by our team and always in line with Abebooks policies: AbeBooks? Return Policy guarantees that you can return any book for a refund within 30 days, when the return is due to an error on the bookseller?s part. When the motive of the return is not due to an error of the seller it is up to Brook Bookstore to accept the return or else after studying the case. CANCELLATION You can send a cancellation request to our customer service team while the package has not yet been shipped. After that we cannot ensure we can retrieve the parcel but we suggest you to get in touch with us in order to verify the case. INVOICE You can request the invoice to be issued together with the shipment of the order or, at the latest, in the same month of the shipment.

Visit Seller's Storefront

Seller's business information

Brandon Group S.R.L.
Via Vannella Gaetani 27, Brandon Group, Napoli, NA, 80121, Italy

Sale & Shipping Terms

Terms of Sale

Account dedicated to Print on Demand titles.

CANCELLATION
You can send a cancellation request from the order page while the package has not yet been shipped. After that we cannot ensure we can retrieve the parcel but we suggest you to get in touch with us in order to verify the case.

INVOICE
You can request the invoice to be issued together with the shipment of the order or, at the latest, in the same month of the shipment.

RETURNS
If you want to return your order, please contact us for authoriz...

More Information

Shipping Terms

Shipping rates from Italy to U.S.A.

Shipping rates from Italy to U.S.A.
Order quantity	25 to 40 business days	60 to 60 business days
First item	US$ 12.77	US$ 593.19

Delivery times are set by sellers and vary by carrier and location. Orders passing through Customs may face delays and buyers are responsible for any associated duties or fees. Sellers may contact you regarding additional charges to cover any increased costs to ship your items.