Contract manufacturing

Quality Audit. Another important responsibiUty of quahty assurance is the audit function. Using the quahty audit as a tool, QA can monitor the operation of the manufacturing faciUty a toU, ie, contract, manufacturer or raw material suppHer to assure that written procedures are in place and that there is documentation to indicate the procedures are being followed. Properly executed audits allow QA to spot potential weakness in the quahty system that could allow errors to occur. Once identified, these weaknesses can then be corrected before they result in nonconformance. 

Toller An outsourced manufacturing company contracted to process materials to another company s specifications. Sometimes called third party service provider, toll processor, supplier of outside services, external contract manufacturer, contract processor, contract manufacturer, custom chemical manufacturer. 

Quality Management Personnel Premises and Equipment Documentation Production Quality Control Contract Manufacture and Analysis Complaints and Product Recall Self Inspection... 

Richard L. Rowe is retired chief executive officer of MCMS, Inc., a 550 million electronics contract manufacturing company. His experience includes sensor technologies applied to aviation security, and his expertise includes new technologies in optics and radio frequency, electronic sensors, and switch products. He has more than 20 years of experience in the electronic sensors and switch products in-... 

Its contract manufacturing is categorized in two different areas (i) topical compositions, which resemble traditional creams, lotions, and ointments in appearance and use, and (ii) liquid compositions that can be absorbed sublingually, nasal spray products, or liquid ingestion products. 

Goodwin Biotechnology, Inc. (GBI) is a fully integrated GMP contract manufacturer of mammalian cell products providing process development (upstream and downstream) and cell banking through production, purification, and sterile fill. The downstream... 

Contract manufacturers, 19 462 Contractor pumps, 21 78 Contractors, use for routine maintenance, 15 478... 

Not all of these stages will be realized by every facility or for every process. For example, in contract manufacturing the technology may already be developed, and facility construction and start-up stages may only... 

Contractors, contract manufacturers, transporters, warehouses, and end users of reactive chemicals should be informed not only of chemical reactivity hazards, but provided information or training on how to control them. This should be done as part of product life-cycle management and Responsible Care/Product Stewardship. Specific issues needing to be addressed may include but probably are not limited to those that are highlighted during the hazard/risk analyses (Section 4.5), including ... 

Company C is a small custom chemical manufacturer. Contract manufacturing accounts for its entire business. CSB staff visited a small manufacturing site with several batch chemical manufacturing operations. The nature of custom chemical manufacturing translates into very frequent changes in chemicals handled and processed. 

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. 

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. 

The Amb a 1 concentration of the final purified intermediate bulk is determined by an absorbance method chosen for its precision, accuracy, and simplicity. Because Amb a 1 bulk intermediate will now be conjugated to 1018 ISS (and the number of linked 1018 ISS affects the activity of the resulting AIC), it is essential to quantitate the Amb a 1 concentration accurately and precisely. A significant over- or underestimation of protein concentration will result in an over- or underestimation of the heterobifunctional linker required to activate the protein for coupling to 1018 ISS. The absorbance method, more dependent on well-calibrated instrumentation than lab technique, was chosen because it is an easy procedure to transfer to the production site. Dilution skills are the only requirement for robust performance of a well-developed and validated absorbance method. Hence a contract manufacturing site could readily quantitate Amb a 1 without the... 

Type V Facilities for production, contract manufacturing facilities and testing facilities... 

The Type V DMF enables confidential information to be submitted to the FDA, for example, a contract manufacturing facility may provide proprietary information to the FDA without divulging it to the Sponsor client. The FDA reviews the DMF, but the DMF is never approved or disapproved. The holder of the DMF is notified of deficiencies for rectification. It is the holder s responsibility to update the DMF on an annual basis. 

The TGA conducts regular Inspections of Australian manufacturing operations to ensure compliance with the code of GMP. Scrutiny has increased, including imannounced inspections, since the major recall of a contract manufacturer s wide range of products In 2003 (see Section 24.3.20). 

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. 

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