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Quality Assurance Report

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Submitted By julieanne9
Words 557
Pages 3
Quality assurance
By Julieanne Naji

Scope

The quality assurance plane mandates that the LIMS La Trobe University laboratory is compliant with up to date quality measures, in order to transition from a teaching facility into a testing facility. The teaching facility will be contracted to produce large amounts of GFP protein in order to produce specific anti-GFP antibodies.
The quality assurance section has specifically looked into stock maintenance, reagent maintenance, testing and data management in order to assess if the facility will adhere to good laboratory practice (GLP) if turned into a test facility. Section five to seven has covered other specific sections of quality assurance, such as personnel, facilities and standard operating procedures. The quality assurance audit has provided recommendations in order for the teaching facility to be approved and fall under GLP, to become a test facility.

I. Reagents storage
Reagents are stored appropriately, within the flammable cupboard, labeled shelves, appropriate temperature controlled rooms and temperature controlled refrigerators. Reagent storage location also contained appropriate labeling within refrigerators and shelves II. Working reagents
Working reagents have been left on benches, the working reagents have not been labeled or left in a specific controlled temperature.
Recommendations: The laboratory will need to appropriately label working reagents, and ensure they are stored in a safe and temperature controlled location when not in use. Labeling will also have to entail who created the working reagent. III. Outsourced products
Products attained from other companies have been adequately stored; a record of date of purchase, lot number and usage is kept on a spreadsheet. Although supplier sheets from outsourced companies are not kept and stored.
Recommendations: Supplier sheets must be kept and stored for all staff to access, which may contain quality assurance information as well as any expiration dates. IV. Labeling & Records
There is no formal labeling system in place for reagents. There is also no formal record system of who has made each reagent and as to which date these regents were manufactured.
Recommendations: In order to ensure the viability of all working reagents, a logbook must be kept, entailing who was responsible for making the working reagents, and as to which date they were made. I suggest there be a logbook at each working bench, easily accessible by staff. A formal labeling system must be put in place; pre-made labels with name, date and reagent content should be left at each working bench. These labels should be appropriately filled out and adhered to each working reagent by the manufacturer. V. Testing output
Reagents, bacterial products and plasmids are only used in the manufacturing of final products. The viability of products is not tested, and results from manufactured product are never repeated.
Recommendations: To ensure correct results of final manufactured products, the procedure and products must be tested repeatedly. VI. Test spaces
Working areas for computers and desks are not separated from testing areas.
Recommendations: There must be a divide between these two areas; a screen may be put in place to separate the two sections as to decrease any contamination of products, and workspace equipment; such as computers and desks. VII. Disposal of waste
Bacterial waste is autoclaved appropriately, protective garments are bleached and liquids waste is disposed and bleached. VIII. Data
Results are sufficiently kept and updated on the La Trobe university computer database.

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