Pharmaceuticals contract manufacturing

Linna, A., Korhonen, M., Mannermaa, J., Airaksinen, M., Juppo, A. Developing a tool for the preparation of GMP audit of pharmaceutical contract manufacturer. European Journal Pharmaceutics Biopharmaceutics, 69, 2008, 786-792. 

M Valazza. GMP issues and documentation for bulk pharmaceutical contract manufacturers. Pharm Technol 48-51, November 1992. 

Pharmaceutical contract manufacturing Powders, wet and dry granules, tablets (film coated, dispersible, effervescent) and associated equipment). 

Thielmann, F., Naderi, M., Ansari, M. A., Stepanek, F. The effect of primary particle surface energy on agglomeration rate in fluidised bed granulation. Powder Technol., 181, 2008, 160-168.M. J. Valazza, G. G. Wada. Creating a successful partnership with a contract manufacturer. Pharmaceutical Technology Europe, 13(5), 2001, 26-34. 

In April/May 2003 the TGA forced the recall of approximately 1600 complementary medicines at retail level throughout Australia, due to concerns about the quality of their manufacture. The recalled products were manufactured in Australia by Pan Pharmaceuticals, principally as a contract manufacturer for other companies. The resultant publicity impacted around the world and highlighted the importance of effective implementation of GMP standards for all therapeutic products. In view of the issues raised by this massive recall, and to restore community confidence, an Expert Committee on Complementary Medicines in the Health System was established to consider a wide range of matters relating to complementary medicines. Their report was published in September 2003 and is available from the TGA website. 

With respect to the pharmaceutical industry, outsourcing and contract manufacture probably got its start with APIs, final and key intermediates, and other steps... 

It benefits both parties of a contract manufacturing agreement to give specific details on the master production record when a pharmaceutical product will be manufactured by a contractor. Some items that need to be covered by an agreement include the following ... 

Contract Manufacturer A company that manufactures products that will be sold under the brand names of its client companies. For example, a large number of consumer electronics, such as laptop computers, are manufactured by contract manufacturers for leading brand-name computer companies such as Dell. Many other types of products are made under contract manufacturing, from apparel to pharmaceuticals. Also see Original Equipment Manufacturer (OEM) and Original Design Manufacturer (ODM). ... 

For imported pharmaceuticals, the foreign manufacturer has to appoint its local subsidiary or a local agent to apply for registration. In the event the product is manufactured by a contract manufacturer, the appointment may be made by the contractor company which holds the registration of the product. 

There are a number of contract manufacturers, for example, Interphil (subsidiary of Zuellig), and pharmaceutical manufacturers, which provide for 30% of the market 95% of the pharmaceutical raw materials are imported, with finishing and packaging carried out locally. 

Fig. 2 This figure represents the career options for individuals interested in the clinical pharmaceutical sciences. Abbreviations PhaRMA, Pharmaceutical Research Manufacturers CROs, Contract Research Organizations SMOs, Site Management Organizations NIH, National Institutes of Health CDC, Center for Disease Control and Prevention HCFA, Health Care Financing Administration FDA, Food and Drug Administration EPA, Environmental Protection Agency CDER, Center for Drug Evaluation Research CBER, Center for Biological Evaluation Research.

Organic Chemicals has manufacturing operations in the UK and the USA, and focuses on contract manufacture (agrochemicals, coatings, personal care and pharmaceuticals), and fine chemical intermediates (pharmaceuticals, pigments and detergents) ... 

Increased worldwide needs for recombinant biopharmaceutical proteins drive major investments into the construction of new bioreactor fadhties. In addition to those companies that produce their own protein pharmaceuticals in large-scale manufacturing plants, a few contract manufacturers offered in 2004 a bioreactor ca-... 

An increasing number of companies include contract manufacturing into their plans for developing a bio-pharmaceutical drug (Table 16.2). Although, initially an appropriate quantity of material is required for toxicology studies (the pre-dinical phase), much larger quantities will be required further down the development chain as the clinical phase approaches (Fig. 16.3). 

Projecting market demand for specific classes of therapeutics in development will remain a major planning issue for bio-pharmaceutical companies. The ability to meet the demand for biopharmaceutical production capacity, whether through in-house manufacturing or outsourced contract manufacturing, carries strategic and financial implications. Also, FDA approval policy and the development of the biogenerics market will have a major impact on future capacity requirements (see Part VII, Chapter 4). 

Other kinds of start-ups are less risky than nascent pharmaceutical companies. For example, a newly founded custom-synthesis house or a contract manufacturer of intermediate compoimds and bulk drugs may have orders booked long in advance. Depending for its revenues on several fipcos, such a firm is largely independent of the success or failure of any one substance undergoing dmg development. 

Applicant Center P.O. Box 1655 Midland, MI 48641-1655 Internet site www.dow.com process development and contract manufacturing services bulk pharmaceuticals Web site specifies campuses where the company recruits workers invites applications by surface mail, asking for e-mail addresses... 

In this service facility an increasing amount of contract manufacturing is performed, work for the production of intermediate components, which contain fibers and dismtegrants. The resulting materials include the functionality as provided by the company s products and are used for the formulation of the customer s final specialty, for example easily dispersible pharmaceutical tablets or detergent compacts. 

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