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© SeerPharma Pty Ltd This training program is copyright to SeerPharma Pty Ltd and may not be modified, reproduced, sold, loaned, hired or traded in any form without the express written permission of SeerPharma Pty Limited, SeerPharma (Singapore) Pte Ltd or its subsidiaries. G(QC)LP HES6404 Good (Quality Control) Laboratory Practices Assignment 2 The student must complete all parts of the attached assignment. The assignment for formal assessment should be between 750 and 1500 words, or equivalent and is worth 20% of the overall mark for the subject. The work must be your own and should include a bibliography of source material. Marks will be allocated for presentation. All assignments should be uploaded to Blackboard Safe Assign on, or prior to the date specified in your Student Notes together with a hard copy in class. HES6404 Assignment 2-2011
HES6404 Good (QC) Laboratory Practices A2-Ver 1-2011 © SeerPharma Pty Ltd Page 2 of 2 G(QC)LP HES6404 Please read the attached FDA Warning Letter relating to lack of good laboratory practices. Using the following industry rules and guidance: (1) the FDA CFR 211 Regulations -http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211 and (2) PIC/S PI 023-2 Aide Memoire On Inspection Of Quality Control Laboratories http://www.picscheme.org/publication.php?id=14 Assignment: Review the warning letter citations and identify the GMP Rules within each of the two references above the rules that apply to the problems. Explain very briefly (one paragraph only) what the purpose of the applicable rules is (NOTE: you need to say more than just “compliance” or “ensure product quality”) You may submit this in tabular format for if you wish. Points to Note: The assignment will be assessed on the quality of the content provided, specifically whether it addressed all the points in the instructions, and the author’s ability to convey an understanding of the material presented. Marks will be allocated as follows:…