Navigation Links
FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
Date:11/18/2013

Falls Church, VA (PRWEB) November 18, 2013

Managing Contract Manufacturers and Testing Labs
**FDAnews Management Report**
http://www.fdanews.com/ContractManufacturers

When a contract manufacturer or testing lab notices something unusual about a company’s product — an unusual result, a change in raw materials supplier, a new piece of equipment or packaging — do they react the way the company wants?

  •     Do they know the batch release requirements?
  •     Do their certificates of analysis satisfy the company’s needs?
  •     Have they changed software?
  •     Do they know the storage parameters for the 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.

Order Today

This comprehensive, step-by-step guide is written by the foremost authorities in the pharmaceutical manufacturing field. It will walk readers through an exhaustive, 45-topic analysis of managing contractors. Plus it’s loaded with tools and samples that will make 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 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 readers can put to use today, including:

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

Plus a troubleshooting guide to the most common mistakes made in contracting services.

Time for Action …
If the company just starting to outsource, or already managing contracted services, this report will help make sure contracted manufacturers and testing facilities are operating in compliance with the FDA and EU GMP principles, and most of all, the company’s own high standards.

Order Today

Managing Contract Manufacturers and Testing Labs
**FDAnews Management Report**
http://www.fdanews.com/ContractManufacturers

FORMAT: Print or PDF
PRICE: $377

EASY WAYS TO ORDER
Online:     http://www.fdanews.com/ContractManufacturers
By phone: 888-838-5578 or 703-538-7600

ABOUT FDANEWS
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at http://www.prweb.com/releases/FDAnews/ContractManufacturers/prweb11340091.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. FDAnews Announces The FDA Unique Device Identification (UDI) Rule Virtual Conference
2. FusionHealth Unveils New Technology to Expand its Sleep4YourHealth® Sleep Health Management Solution
3. Orthobalance Physical Therapy Offers State-Of-The-Art Treatment for Balance Restoration and Fall Risk Management
4. Chestnut Street Apartments, San Francisco's Hottest Russian Hill Apartments for Rent, Participates in Trinity Management Job Fair
5. San Francisco's Top Pacific Heights Apartments for Rent, 2000 Broadway Apartments, to Participate in Trinity Management Job Fair
6. Crystal Tower Apartments, San Francisco's Top North Beach Apartments For Rent, Participates In Trinity Management Job Fair
7. Altec Participates as Gold Sponsor of GPUC Event Presenting the Power of Integrated Document Management to Microsoft Dynamic End Users
8. Primary care key to management of patients with HIV infection
9. Network Management Market (Performance Monitoring, Security) Worth $ 6.35 Billion by 2018 - New Report by MarketsandMarkets
10. Global Pain Management Devices Market - Industry Analysis, Size, Share, Growth, Trends and Forecast, 2012 - 2018
11. Compression Therapy Market to 2019 - Growth due to Increased Awareness in Venous Disease Management Offset by Reimbursement Issues
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... , ... June 27, 2016 , ... TopConsumerReviews.com recently awarded ... Eyeglasses . , Millions of individuals in the United States and Canada wear ... a way to both correct vision and make a fashion statement. Even celebrities use ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media ... give their videos a whole new perspective by using the title layers in ... Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/26/2016)... Birmingham, Lake Orion, Clarkston, Michigan (PRWEB) , ... ... ... their direction with respect to fertility once they have been diagnosed with endometriosis. ... for tolerable intercourse but they also require a comprehensive approach that can help ...
(Date:6/25/2016)... ... ... closing of Bruton Memorial Library on June 21 due to a possible lice infestation, as ... of head lice: the parasite’s ability to live away from a human host, and to ... one in the event that lice have simply gotten out of control. , As lice ...
(Date:6/25/2016)... ... ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors in ... School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green Hospital ... at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train in ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016   Bay Area Lyme Foundation ... Dean Center for Tick Borne Illness , Harvard ... MIT Hacking Medicine, University of California, Berkeley, and ... the five finalists of Lyme Innovation , ... than 100 scientists, clinicians, researchers, entrepreneurs, and investors ...
(Date:6/24/2016)... 24, 2016 Research and ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" report ... In-Mold Electronics, Smart Skin, Structural Health Monitoring, ... Structural electronics involves electronic and/or electrical components ... replacing dumb structures such as vehicle bodies or ...
(Date:6/24/2016)... Dehaier Medical Systems Ltd. (NASDAQ: DHRM ) ... medical devices and wearable sleep respiratory products in ... with Hongyuan Supply Chain Management Co., Ltd. (hereinafter referred ... to develop Dehaier,s new Internet medical technology business. ... Hongyuan Supply Chain,s sales platform to reach Dehaier,s dealers ...
Breaking Medicine Technology: