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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

Technical Requirements

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Filesize: 376 KB

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Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.
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.

FDA Regulatory Compliance Consulting, USA

Hiob, Dr. Michael

Ministry for Health of Land Schleswig-Holstein, Germany

Peither, Thomas

Maas & Peither, Germany, USA

Wawretschek, Cornelia

GxP Services, Germany

Böttcher, Dr. Frank

Labor L+S AG, Germany

GMP-Questionnaire: Contract manufacturing / Contract analysis