Quality System on Data Integrity and Improve the Medicines Paper

– Good Manufacturing Practices (GMPs)Course Assignments:
Topic: Data Integrity impact on the development of new medicines
Data integrity is a serious issue for the past three years, and Regulatory Agencies are
cracking down on violations. Development of guidelines around data integrity also
increases significantly. Write a paper to discuss this issue and its impact on drug quality.
Since data integrity has a wide span, you should select a specific area to write your report.
This paper should address what data integrity is, how it impacts quality system, what are
the potential changes (positive and negative), your analysis and your proposals on how
the program should be developed to address those issues or changes.
You could also use a warning letter (www.fda.gov) on data integrity as a start if desired.
Two Assignments:
Part I: Write a short paper
• An outline and a paper
• Peer review of some others’ papers
Part II: Make a presentation
• A recorded presentation (5‐10 min) to summarize your paper
Remember:
▪ Quality counts, not Quantity
▪ Technical writing nor fiction
– Good Manufacturing Practices (GMPs)
CLASS REPORT
Part I: A written paper
▪ Approx. 5 typed pages using WORD, 1.5 spaces (I expect a good report style format.
Remember, this is a graduate‐level course)
▪ Tables, graphs, flow chart, figures must be properly labeled & identified
▪ Using the third person as possible, avoid contractions
Grading:
▪ A total of 100 points, contributing 25% of your final grade.
▪ It will be graded based on Content, punctuation/grammar, presentation, and
originality.
▪ The Grade will split into 3 parts:
▪ Topic and outline 20%
▪ Final paper – 70%
▪ Complete Peer Review of another 3 papers –10%
Table of Contents (Please use as a Guide):
1. Executive Summary
2. Introduction
a. What quality system or area that you are writing on
b. General background information
c. How does data integrity impact this area
d. Why is it a problem?
3. The extent of the problem:
a. Who is affected? What is impacted? What risk involved?
b. Evidence (info) to support your concern
4. Possible solutions to the potential impact
a. How to fix it (time, resources, cost)
b. Why do we need to fix it
c. Evidence (data/info) to support your proposal
5. Conclusion
6. References
– Good Manufacturing Practices (GMPs)
CLASS PRESENTATION
Part II: A Presentation
•
Prepare a brief presentation (summary) of your paper. It should not be more
than 10 minutes.
•
You could do it on Blackboard Collaborate Ultra, or Sharepoint, or Youtube, as
long as I have a link that I can access it to grade it.
Grading:
▪ A total of 50 points, contributing to your participation grade (15%).
▪ It will be graded based on Content, punctuation/grammar, presentation, and
originality.
1
Running head: MANUFACTURING PRACTICES
Manufacturing practices outline
Name
Institution
2
MANUFACTURING PRACTICES
Data integrity in medicine outline
Thesis statement? Data integrity is development of new medicines will lead to high quality
medicines promoting an advanced health care.
1. Introduction
2. Body
a. Impacts of data integrity on
•
The quality of the system.
•
The quality of the drugs.
•
The level of health care quality.
•
The originality of the medicine.
•
Restoration of confidence into the pharmaceutical system.
•
Avoiding revenue loss through mistrust from patients.
b. Consequences of violation of data integrity
•
Warning letters from FDA.
•
Revocation of practicing license.
•
Imprisonment.
c. Proposal
Data integrity can be very effective in promoting a quality health care while
promoting high quality products. The government should enact and impose tough
rues that pertain to medicine which is a sensitive sector in the economy.
d. Conclusion
e. References