Sebastian Sandoval Medina1520122020
María Viviana López Montesdeoca 1520122029
International Business I
University of Ibagué
Contract manufacturing is an outsourcing of certain production activities that were
previously perform by the manufacturer to a third-party. A company may outsource the
manufacture of certain components for the product or outsource the assembly of the
product. Nowadays, outsourcing companies have become specialists in a multitude of
services for manufacturers including design, production, assembly and distribution.
Outsourcing occurs when a company purchases products or services from an outside supplier,
rather than performing the same work within its own facilities, in order to cut costs.
Advantages Disadvantages
• Cost savings
• Staffing levels
• Focus
• Morale
• Flexibility
• Knowledge
• Accountability
• Poor quality control
• Decreased company
loyalty
• Lengthy bid process
• Loss of strategic
alignment
Parties involved in the contract manufacturing of
drugs can utilize Quality Agreements to delineate
their responsibilities and assure drug quality, safety,
and efficacy. This guidance applies to the commercial
manufacturing of Active Pharmaceutical Ingredients
(APIs or drug substances, or their intermediates),
finished drug products, combination products, and
biological drug products. For the purposes of this
guidance, the term “manufacturing” includes
processing, packing, holding, labeling operations,
testing, and operations of the Quality Unit
Electronic Manufacturers
Services
Pharmaceutical Manufacturing
Services
Medical Contract
Manufacturing
Contract Manufacturing
Agencies
Our contract manufacturing services
includes
•Liquid, semi-solid encapsulation in two-piece,
hard-shell capsules (Gelatine, HPMC, etc.)
•Production volume capacity of >300 million
capsules/annum
•Blister or bottle packing for finished drug
product
•Clinical trial finished drug product supply
•Bulk drug & placebo capsule Bulk
capsules/blister-packs/bottle Batch release
•ICH stability testing
•Project and logistics management
Third Party Manufacturing
Manufacturer & Supplier of Third Party
Manufacturing. Our product range also comprises
of Antibiotic Drugs, Anti Inflammatory Drugs and
Antifungal & Anti Worm Drugs.
http://education-portal.com/academy/lesson/what-is-contract-manufacturing-definition-lesson-quiz.html#lesson
http://www.referenceforbusiness.com/small/Op-Qu/Outsourcing.html
http://www.lachmanconsultants.com/fda-means-business-watch-out-contract-facilities-and-product-owners.asp
http://www.wisegeek.com/what-are-the-different-types-of-contract-manufacturing-services.htm
http://www.ehow.com/info_8503681_advantages-disadvantages-contract-manufacturing.html
http://www.tillotts.com/tillotts-services/our-services/contract-manufacturing
http://www.indiamart.com/nationalchemical/third-party-manufacturing.html
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