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Pharmaceutical Technology Transfer (PTT)
Lecturers: Paula Kearney & John O’Brien Module: Pharmaceutical Technology Transfer (PTT) AssignmentTitle: Transfer of a developed Covid vaccine from a U.S based manufacturing site to a European manufacturing site. The Learning outcomes for this module are as follows: 1. Critically analyse the key drivers for a technology transfer from facility to facility 2. Research and critique the key activities involved in a technology transfer. 3. Demonstrate the key project management aspects of a technology transfer 4. Research and assess the challenges involved during a typical validation process 5. Establish an appropriate technology transfer protocol for a pharmaceutical product transfer This assessment is based on the project management stages for a technology transfer between two biopharmaceutical manufacturing plants based in different regulatory jurisdictions Rules and Guidelines: Submit a softcopy of assignment through Turnitin on Moodle by Friday10th December 2021 @ 11pm. A maximum of three submissions are allowed – each version overwrites the previous one. A similarity value of more than 30% will be investigated further and marks may be deducted. Anything exceeding 3000 words+10% will not be corrected. Plagiarism of any kind will not be tolerated. At best, any plagiarised sections of the assignment will be excluded from marking and at worst, a case of academic misconduct will be initiated. No extensions will be allowed, and late submissions will be subject to penalties (10% loss of awarded marks for up to one week late, 20% loss of awarded marks for up to two weeks late and a cap of 40% on anything submitted over two weeks late). See rubric below for marking details. Assignment format for this Individual Assignment Instructions: Analyse and discuss the elements involved in a technology transfer in terms of the four stages of project management. (Initiation, Planning, Execution and Close Out). Note: The receiving site is developed and currently manufacturing. The project is yours to develop as you see fit e.g.,requirements/ gaps/ risks. Rationale for decisions should have referenced support – EudraLex Vol 4 cGMP,Pharmacopoeia, ICH, published documents etc. Position yourself as the project manager of this tech transfer as if it was to start now: Include cover page (attached), short introduction to the project and conclusion. Initiate: Identify a high-end overview of the requirements, gaps and risks involved in the TT from the US to the European plant. Sending andreceiving site information requiredWhat are the Validation Master Plan (VMP) main areas of focus such as facilities, personnel& cleaning etcOutline the potential gaps and risks with the TT in the VMP areas mentioned above Planning: Discuss the potential gaps and risks in greater detail and propose solutions to address these issues. Identifying any possible gaps (Gap analysis) in the information package from the donor site and determine the criticality (Risk analysis) of the information gaps to the progression of the process development phase of the transfer. Example:introducing a newchromatography column would not be critical at this point while upgrading to a class A clean room would. Propose solutions to address the gaps/risks foundUtilise references in providing rational for you decision Execution: Evaluate theprocess validation and cleaning validation throughout the manufacture of your drug. Determine the Critical Quality Attributes (CQA’s) and Critical Process Parameters (CPP’s) involved in its manufacture and some possible analytical methods such as Process Analytical Technologies (PAT) that you could utilise to monitor their conformity. Summarise why we validate. CQA’s such as Viral Inactivation (VI), CPP’s the pH range change and time for hold and base addition. Analytical methods such as Bioburden plate samples/ cleaning swab studies etcReview Annex 15. Close Out: Review the ProcessValidation Lifecycle and summarise any actions that a company could implement to keep them in a validated state. Example: Continuous Improvements, continuous sampling, staying regulatory compliant etc. Referencing & Layout:Use Harvard referencing and embed your references in the body of the assignment. Use reputable and relevant sources for your information such as https://ec.europa.eu/health/documents/eudralex/vol-4_enand https://www.ich.org/page/quality-guidelinesand academic databases. Text: Arial, Size 12, 1.5 line spacing, incl page numbers. Percentage 20% (600-700 words) 30% (900- 1000 words) 20% (600-700 words) 20% (600- 700 words) 10% Total Percentage 100% Word/Page count: 3000words ± 10%, excluding cover pageand reference section. Total: 100% for Module
Grading Scheme forIndividual TTAssignment
| Descriptors: | Choice of suitable VMP areas, Gaps and Risk Identified | Identification and analysis of the gaps and risks. Solutions identified | Quality of references / sources of information&layout | ||
| CQA’s and CPP’s identified. PAT relevance | Continuous validation lifecycle review. Actions that the company could implement | ||||
| Weighting | 20% | 30% | 20% | 20% | 10% |
| 80 + | Great clarity in the explanation of therequirements, gaps and risks involved in the TT. The VMP areas are extremely well defined. Shows excellent insight/understanding and reasoning for the VMP area selection | Excellent identification and analysis of gaps and risks in each area. Excellent solutions identified to rectify these issues | Excellent review of the required CQA’s and CPP’s required for the manufacture of the drug product. Excellent description and support for PAT’s introduction to the process | Excellent review of the continuous validation lifecycle. Excellent identification of the actions a company could implement to stay in a validated state | Exceptional choice of relevant, top-quality sources for the assignment. Absolutely central to the focus of the assignment. Exceptional Layout |
| 70-79 | Very good clarity in the explanation of therequirements, gaps and risks involved in the TT. The VMP areas are very well defined. Shows very good insight/understanding and reasoning for VMP areas selection | Very good identification and analysis of gaps and risks in each area. Very goodsolutions identified to rectify these issues | Very goodreview of the required CQA’s and CPP’s required for the manufacture of the drug product. Very good description and support for PAT’s introduction to the process | Very goodreview of the continuous validation lifecycle. Very good identification of the actions a company could implement to stay in a validated state | Very good choice of relevant, worthy sources for the assignment. Of major importance to the focus of the assignment. Very good layout |
| 60-69 | Good clarity in the explanation of the requirements, gaps and risks involved in the TT. The VMP areas are well defined. Shows good insight/understanding and reasoning for VMP areas selection | Good identification and analysis of gap and risks in each area. Goodsolutions identified to rectify these issues | Goodreview of the required CQA’s and CPP’s required for the manufacture of the drug product. Good description and support for PAT’s introduction to the process | Good review of the continuous validation lifecycle. Good identification of the actions a company could implement to stay in a validated state | Good choice of relevant, quality sources. Of considerable importance to the focus of the assignment. Good layout |
| 50-59 | The choice of requirements, gaps and risks involved in the TT defined reasonably well. The explanation of the selected VMP areas is clear but needs some interpretation and reasoning forselection. | Reasonable identification and analysis of gap and risks in each area. Reasonable solutions identified to rectify these issues | Reasonablereview of the required CQA’s and CPP’s required for the manufacture of the drug product. Some flaws in the description and support for PAT’s introduction to the process | Reasonablereview of the continuous validation lifecycle. Reasonable identification of the actions a company could implement to stay in a validated state | Mostly relevant, quality sources. Decent layout |
| 40-49 | The choice of requirements, gaps and risks involved in the TTis only satisfactory. The interpretation and reasoning for VMP areas selectionis limited. | Basic identification and analysis of gap and risks in each area. Basicsolutions identified to rectify these issues | Only some of the required CQA’s and CPP’s required for the manufacture of the drug product were discussed Basic insight and understanding of the possible PAT’s involved in the process | Review of the continuous validation lifecycle was insufficient Few actions identified | Some of the references are relevant but the quality of many of the sources needs to be improved. Basic layout |
| 30-39 | Insufficient choice requirements, gaps and risks involved in the TT / information provided is limited. The interpretation and reasoning for VMP areas selection is poor | Incorrect or inadequategaps, risks and solutions identified. | Does not appear to understand severalheadings. Support for answers is very poor. | There is no review of the continuous validation lifecycle. No understanding of the actions a company could implement to stay in a validated state | Poor selection of sources. Many lack relevance to the objectives of the assignment. Poor layout |
| 0 -29 | There is no interpretation and reasoning for requirements, gaps and risks involved in the TT selection. | Does not conform to instructions. No insight into subject matter. No Gaps, risks or solutions identified | Many of the answers are inappropriate demonstrating that the question is not understood. Does not support headings with relevant answers | Report lacks any discussion. No insight into subject matter. Does not understand what is required. | Very poor selection of sources. Many are questionable and are not particularly relevant. Very poor layout |
Assignment Cover Sheet
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| Plagiarism disclaimer: I/We understand that plagiarism is a serious offence and have read and understood the college policy on plagiarism. I/We also understand that I/We may receive a mark of zero if I/We have not identified and properly attributed sources which have been used, referred to, or have in any way influenced the preparation of this assignment, or if I/We have knowingly allowed others to plagiarise my/our work in this way. I/We hereby certify that this assignment is my/our own work, based on my/our personal study and/or research, and that I/we have acknowledged all material and sources used in its preparation. I/we also certify that the assignment has not previously been submitted for assessment and that I/we have not copied in part or whole or otherwise plagiarised the work of anyone else, including other students. Signed & dated: |
| Please note: Students MUST retain a hard / soft copy of ALL assignments as well as a receipt issued and signed by a member of Faculty as proof of submission. |
