GILEAD SCIENCES

PHARMACEUTICAL INDUSTRY

OVERVIEW

Gilead Sciences, Inc., is an American biopharmaceutical company that researches, develops

and commercializes drugs. The company focuses primarily on antiviral drugs used in the
treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni.

The 4 main functions in this particular organization are Production (Manufacturing), Quality,
Operations, Research and Development

PRODUCTION

Deal with all stages of pharmaceutical product manufacture – from producing active ingredients,
through to completion of finished products and even packaging Due to this diversity, work in this
area can take many forms and involve the use of specialist machinery.

The processes involved in this function of the organization are:

❖ Upstream & Downstream activities –

o Upstream activities are stages of biopharmaceutical processing up to the cell-culture or

fermentation process that is used to make the target proteins.

o Downstream activities are the stages of processing that come after cell culture or
fermentation. These stages include separation and purification to achieve the required drug
product

❖ Manufacturing, Science & Technology (MSAT)

o Supports operations with activities such as continuous process improvement, implementing

new technologies and troubleshooting.

❖ Fill Finish/Packaging –
o Some of the final stages of the manufacture process where the active agent is prepared into
its final form, before being filled and sealed within containers.
QUALITY

Functional area that monitors and documents activities, processes and products of manufacturing to
ensure they meet strict standards and predefined expectations. Ultimately, this team ensures the
safety of the drugs that go out for distribution – their activities are essential within such a regulated
industry.

The processes involved in this function of the organization are:

❖ Quality Assurance – monitors and test processes to ensure results fall within predetermined
ranges
❖ Quality Control – tests products of manufacturing process to ensure meets predefined criteria
❖ Validation – creates an evidence trail to show a process or system leads to a consistent result
that can be reproduced

OPERATIONS

Ensures the continuous functioning of the manufacturing plant and its equipment.

The processes involved in this function of the organization are

❖ Technical Services –
o Generally, workers will have a minimum of an Ordinary Degree level qualification alongside
relevant experience. The kind of services provided here include facility management,
equipment maintenance and clean utilities

❖ IT/Automation –
o Supports operations with activities such as Calibration and Automation

RESEARCH AND DEVELOPMENT

Where staff are engaged in making improvements and modifications to existing production processes
and identifying possible new production technologies and applications.

❖ Typically R & D doesn’t include any specific due to the overall nature of this function to the
organization but it mostly Varies depending on products and areas targeted for product
improvement

Done By:

Mohammed Taha DIv B 19030122092