This document discusses contract manufacturing. It defines contract manufacturing as outsourcing certain production activities, such as component manufacturing or product assembly, to a third party. Outsourcing allows companies to cut costs. Advantages of contract manufacturing include cost savings, flexibility, and a focus on core competencies, while disadvantages can include decreased quality control and loss of strategic alignment. The document also provides examples of industries that utilize contract manufacturing, such as pharmaceuticals and electronics. It lists some common contract manufacturing services like packaging, clinical trial supply, and quality testing.

1. Sebastian Sandoval Medina
1520122020
María Viviana López Montesdeoca
1520122029
International Business I
University of Ibagué

3. 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.

4. 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

5. 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

6. Electronic
Manufacturers
Services
Pharmaceutical
Manufacturing
Services
Medical
Contract
Manufacturing
Contract
Manufacturing
Agencies

9. 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

10. 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.

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htm
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