Task:
1. Discussion Post (1-2minute presentation), requirements are as follows: Select a plant that has been traditionally used by Indigenous Australians for medicinal purposes Describe : the Plant it’s traditional uses the part of the plant used the route of administration active ingredient if known The indigenous story behind the plant examples of the medicinal currently found in pharmacies and what they are being used for Support and Justify post with references to resource materials and personal experience or theoretical examples.
2. Discussion Post Gap Analysis – Release for Supply Checklist In this scenario, I am responsible for conducting RFS checks on finished batches of product. My employer has an RFS checklist available. Link to Mock Release for Supply Checklist[.docx 29KB]Preview the document Review the checklist provided and compare it to the requirements of TGA’s Release for Supply of Medicines (Links to an external site.) document. Do you think this checklist is fit for purpose? Will it be an aid to compliance with the RFS requirements? A number of requirements are not explicitly stated in this form. Why do you think that is? Where do you think they might be recorded? You are NOT required to amend or develop the checklist, only to comment on its suitability and respond to the discussion starter questions above. Support and justify your post with references to resource material and personal experience or theoretical examples.
This document is to be completed by the QA Manager and is certification that the following checks have been carried out and are in compliance with the marketing authorisation.
Manufacturing batch record present and complete and signed by Area Supervisor.
All manufacturing steps have been completed.
All starting materials and component test results within specification.
All in-process and product test results within specification.
Yields and/or reconciliations of starting materials and batch quantities satisfactory.
Reconciliation of pre-printed labels & cartons satisfactory.
Batch number and expiry are correct.
Pressure Differentials acceptable at time of manufacture.
Product specification and test result records certified.
Process Deviations have been reviewed and closed out. No product quality impact.
Stability data available to support the nominated shelf life.
The post Will it be an aid to compliance with the RFS requirements? appeared first on Homeworkaider.
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