My role and requirement:
Total: 6-7 slides
1 slide: Goals and Milestones
A specific SOP might cover Production personnel, Material Control, Training Policy, Quality Management, Records Retention and Disposition, Equipment Management, Training Policy, or Facilities and Buildings)
Attached is the rough draft already started and paper previously done for Factor XIII.
This semester the group project is centered on GMP and SOPs in biomanufacturing. In your role as directors of the biomanufacturing department at a large U.S.-based biotechnology company you will be preparing plans for the production, training and improvements associated with manufacturing of a new protein of interest. The steps that follow are critical in the overall success of the product and include the process of quality control and quality assurance and how manufacturing is connected to future oversight and regulatory approval.
Directing quality control is a key aspect of a biopharmaceutical company and as such an important position in the biotech sector. The key responsibilities for such a position are to build, maintain and document activities on the quality control infrastructure of the company. These are not simple and require a multifunctional team and professionals with a broad view of overall production goals. As Ronald Branning, VP of Quality at Gilead Sciences, said in a recent interview: “In my experience the most successful production operations are comprised of Quality professionals who view product quality and compliance through a manufacturing lens and of Production professionals who manufacture medicine with a product quality and compliance mindset”
In this group assignment you are preparing to orient employees in the manufacturing division to the new production process for the protein identified by your team in the Week 5 group assignment. The assignment is to work together to produce a training presentation that will cover the critical standard operating procedures (SOPs) that will be put in place with this protein production process.
The team is jointly and independently responsible for ensuring a quality presentation is submitted on time. The presentation should be no more than 50 slides. You can use whatever format you decide as a team, though a suggested outline would be:
Introduction 1 slide
Overview of presentation 1 slide
Overview of manufacturing process to be implemented up to 5 slides
Description of the SOPs (1 SOP per team member, the team member who worked on the SOP should be clearly identified) up to 8 slides each
Timeline, Goals and Milestones up to 2 slides
Conclusions 1 slide
Each person on the team will contribute to the overall slides as well as put together the slides on an individual SOP. Depending on the size of the team, these general areas should be covered, with one team member writing up a specific SOP related to that general area:
Production (A specific SOP might cover cleaning and sterilization of equipment, Cell Line Maintenance, Protein Separation, Protein Purification, Media formulation, Quality Assay Procedures, etc.)
Facilities and Equipment (A specific SOP might cover Facility Start Up and Shut Down , Qualification of Equipment, Waste Control and Management, Environmental Monitoring, Storage in Fridges / Freezers, or Equipment cleaning and storage etc.)
Materials (A specific SOP might cover Specifications, Material Types, Sampling, Inventory Control and Reconciliation, Holding and Labeling of Finished Products, In-process materials, or Clinical Supply Shipment etc.)
Quality Systems (A specific SOP might cover Stability Studies, Program to Qualify Vendors, Regulatory and Client Inspections, Product Recalls, Documentation Practice and Review, Tests, or Corrective and Preventative Actions)
GMP Policies (A specific SOP might cover Production personnel, Material Control, Training Policy, Quality Management, Records Retention and Disposition, Equipment Management, Training Policy, or Facilities and Buildings)
For each SOP please include:
Graphical outline of steps (e.g. flowchart)
Equipment and supplies
Methodology and procedures
Critical limits / regulatory criteria
Quality assurance / quality control
Health and safety considerations (e.g. disposal of materials)
References (these can be included in the notes of the Powerpoint)
Here are some examples of SOPs that you can use as references for the type of content and how to present a SOP; some links may be problematic.
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