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Managing Contract Manufacturers and Testing Labs
€ 327.00
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pdf download
A comprehensive step-by-step guide
74 Pages
ISBN: 978-3-943267-14-3
Delivery: immediately after receipt of payment
Excerpt from the GMP MANUAL

When a contract manufacturer or testing lab notices something unusual about your product – an unusual result, a change in raw materials supplier, a new piece of equipment or packaging – do they react the way you want?

- Do they know your batch release requirements?
- Do their certificates of analysis satisfy your needs?
- Have they changed software?
- Do they know the storage parameters for your products?
- Have they changed key personnel?

Problems with a contract manufacturer or lab can emerge in dozens of unexpected places, from changes in personnel or equipment to faulty SOPs and training, the list can seem impossible to tame. Until now.

This comprehensive, step-by-step guide is written by the foremost authorities in the pharmaceutical manufacturing field. It will walk you through an exhaustive, 45-topic analysis of managing contractors. Plus it’s loaded with tools and samples that will make your contract manufacturing headaches disappear.

Managing Contract Manufacturers and Testing Labs walks through the all the steps necessary for managing contract manufacturers, from selection of a company to auditing of ongoing operations, it addresses all the topics you’ll need to consider when contracting, including:

- Manufacture of development or pilot batches;
- Procurement of primary and secondary packaging materials;
- Procurement of raw materials, excipients and active pharmaceutical ingredients;
- Approval of the starting materials;
- Transfer of analytical methods;
- Manufacturing of validation batches;
- Determination of the manufacturing technology;
- Determination of the packaging technology;
- Determination of sampling during validation and routine manufacture;
- Physical and analytical testing scope;
- Release of intermediate products and final products; and
- Storage and delivery of the finished product

The section on managing analytical testing provides additional, practical advice for outsourcing and overseeing lab services, whether they are packaged with manufacturing services or separate. It covers:

- How to solicit and review external laboratories
- Preparing a request for specific services information, including:
- Preliminary audits and qualification
- Establishing lab-to-lab transfer modes
- Determination of analytical methodology
- Contracting basics

In addition to step-by-step guidance, this report includes tools you can put to use today, including:

- Model Contract Frameworks
- Model SOPs
- Sample Audit Checklists
- And more

Reading Sample

Managing Contract Manufacturers and Testing Labs - Reading Sample

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If you’re just starting to outsource, or already managing contracted services, this report will help you make sure your contracted manufacturers and testing facilities are operating in compliance with the FDA and EU GMP principles, and most of all, your own high standards.
Lazar, Max S.

Max Lazar looks back on an outstanding career within the pharmaceutical industry. For more than 35 years he was working with Hoffmann-La Roche. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7 Guidance. His more than 40-year career in the pharmaceutical industry includes numerous memberships in professional organisations and chairs of committees.

Hiob, Dr. Michael

After graduating in Pharmacology and receiving a PhD, he worked as Laboratory Manager and GMP Inspector in the area of pharmacovigilance. He is currently responsible for supervising GMP inspections.

Peither, Thomas

Since 1994 Thomas Peither is working as expert, publisher and consultant in the area of Good Manufacturing Practices for the pharmaceutical industry. In 1999 he co-founded Maas & Peither specialised in publishing professional GMP information and is editor-in-chief. As Peither & Consultants he delivers GMP services for the commercial drug manufacturing

Wawretschek, Cornelia

Cornelia Wawretschek has been working as a freelance QA consultant for 15 years. She has many years of experience in the areas of pharmaceutical processes and analysis with a focus on the development of semi-solid and liquid dosage forms, sterile production as well as investigational medicinal products.

Böttcher, Dr. Frank

Frank Böttcher is a pharmacist who has specialised in pharmaceutical analysis. He has worked in the pharmaceutical industry for many years and has held positions in different companies. He became CEO of Labor L+S AG in 2015 and is responsible for Operations, Quality, HR and Finance. Frank Böttcher is an authorised expert in accordance with the German Drugs Act (AMG § 65.4) and is involved in a number of different working groups that focus on the testing of medicinal products and medical devices. His other areas of expertise include contract agreements in the area of contract manufacture and testing as well as the manufacture and testing of sterile products.

GMP-Questionnaire: Contract manufacturing / Contract analysis