QUAL54219 Simulation Assignment: Quality Manual and Quality Assurance Report Form The quality manual is an important document that provides a general description of an organization’s Quality Management System (QMS). It enables personnel to understand their roles within the organization to ensure that procedures, forms, reports, process and activities are followed to meet the requirements for regulated industry standards.
QUAL54219 Simulation Assignment: Quality Manual and Quality Assurance Report Form
The quality manual is an important document that provides a general description of an organization’s
Quality Management System (QMS). It enables personnel to understand their roles within the
organization to ensure that procedures, forms, reports, process and activities are followed to meet the
requirements for regulated industry standards. For this assignment, you will have the opportunity to
select an industry that you are interested in and write a quality manual for a company you have recently
joined (20 % of final mark). You will then complete a Quality Assurance Report Form to attest that your
organization complies with GMP requirements (15% of final mark).
Due Friday February 25, 2024 before 11:59PM
Select an industry that you are interested within the life sciences sector and consider the following
scenario. You have been recently hired by a new company to help them develop their QMS. The first
task is to help them develop a quality manual. Read the document “Writing the Quality Manual” and
follow the steps to draft the quality manual document for your organization. Then, review the Quality
Assurance Form to observe the type of items Health Canada evaluates to provide site licenses and
ensure that you have thought about all aspects of GMP to ensure your quality manual provides the
necessary information to help you company drive processes within compliance. As mentioned in the
“Writing the Quality Manual” guidance document, the quality manual can be anywhere between 5
pages to 30 pages. What is important is that you provide a good strategy to meet all the QMS
requirements for your organization whether you are manufacturing biologics, cosmetic products, food
products, pharmaceuticals, medical devices, natural health products or veterinary products. In your
document, please include the following:
1) Title page and table of contents
2) A brief description of the company and the type of products that are manufactured at this
company
3) The quality manual for your company which you will create using the provided document. You
may also refer to WHO’s guidance on this subject:
https://www.who.int/publications/m/item/laboratory-quality-manual
4) In the appendix section, include any forms you may have created for your company
5) For this simulation, fill out the Quality Assurance Report Form (QAR) on behalf of you company
in preparation for submission to Health Canada to obtain site licenses to manufacture your
product. Although this QAR for is for natural health products, you can use this form for your
company’s products unless your selected industry has a specific form. This form is worth 15% of
your mark and it will be marked based on completeness. Please make sure that you provide
titles for potential SOPs and a numbering system for the SOPs in your QAR form. You are not
required to include drafts of SOPs for this simulation. Please attach the signed completed QAR
form at the end of you document.
***Please refer to the rubric which will be used to evaluate the quality manual submissions***
https://www.who.int/publications/m/item/laboratory-quality-manual
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