Manufacturing Contract

Sebastian Sandoval Medina1520122020

María Viviana López Montesdeoca 1520122029

International Business I

University of Ibagué

DefinitionContract 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.

OutsourcingOutsourcing 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

Involved parties

Electronic Manufacturers

Services

Pharmaceutical

Manufacturing Services

Medical Contract

Manufacturing

Contract Manufacturing

Agencies

Types of the mode

Advantages

Cost Advantages

• A contract manufacturer may offer cost advantages over a company’s internal production facilities.

Operational Advantages

• A company can gain significant operational advantages by using contract manufacture.

Disadvantages

The Problem of Hidden Costs

• Although companies may gain an apparent cost advantage by using a low-cost contract manufacturer, they must also consider the additional costs of dealing with an outsourcing partner.

Risk Factors in Contract Manufacturing• Although there are important operational

advantages, companies must also be aware of potential risks in contract manufacturing.

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.

Referenceshttp://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