CASE study #3

CaseStudy #3

Please read the following project. As part of your response, please provide a reference list with the references you identified from your literature search (in APA format). In the attachment, you will find the rubric.

Page limit:10 pages – There is no page limit for images, tables, references, and appendices.

You are a new Quality Assurance associate at XYZ Pharmaceuticals Inc. Utilizing the knowledge gained regarding the drug discovery processes and the product lifecycle management, you are to do the following:

1. Create an imaginary drug and explain the drug discovery process as well as development pipeline.
2. Create a sample Standard Operating Procedure (SOP) of one element of the manufacturing process for a novel drug that XYZ Pharmaceuticals is marketing to patients.

List requirements to obtain regulatory approval in either US or Canada.

[LOGO]
Xxxxxx Department
Xxxxxx Division/Function
SOP #
Revision #
Implementation Date
Page #
1 of xx
SOP Owner
Last Reviewed/Update Date
Approval
Standard Operating Procedure
1.
Purpose
Describe the process for .
Describe relevant background information.
2.
Scope
Identify the intended audience and /or activities where the SOP may be relevant.
3.
Prerequisites
Outline information required before proceeding with the listed procedure; for example, worksheets,
documents, IFAS reports, etc.
4.
Responsibilities
Identify the personnel that have a primary role in the SOP and describe how their responsibilities relate to
this SOP. If necessary, include contact information.
5.
Procedure
Provide the steps required to perform this procedure (who, what, when, where, why, how). Include a
process flowchart.
6.
References
List resources that may be useful when performing the procedure; for example, Admin policies, Municipal
Code, government standards and other SOPs.
7.
Definitions
Identify and define frequently used terms or acronyms. Provide additional and/or relevant information
needed to understand this SOP.
Documents: SOP short-form