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