PET cGMP heads-up at SNM Annual Meeting
13 April 2010
LabLogic Systems will be on hand at this year's Society of Nuclear Medicine Annual Meeting (June 5th - 9th Salt Lake City, Utah) to advise PET professionals on how to comply with the need for their industry to meet FDA cGMP regulations that come into force on 12 December 2011.
"Until now the FDA's thinking has been for guidance only, so PET facilities have been able to afford the luxury of ignoring it," explains LabLogic's PET product specialist Elvir Zahirovic.
"Now that the heat is on achieving cGMP compliance in less than two years will look like a mammoth task to many, but fortunately this is a scenario that LabLogic has already anticipated."
"Since 2004 our software specialists have been collaborating with clients active in PET to develop a LIMS called PETra, which is designed to meet the industry's specific requirements in a cGMP environment."
Standard PETra features include:
- Inventory system to track components, materials and supplies.
- Chain of custody; from point of order through to its use in a batch.
- Automatic expiration and dating.
- Quality Control data is linked to each raw material.
- Automated re-ordering when materials reach critical stock level.
- Label generation with barcodes.
- Recording of all production steps including all operations to the point of final release of a finished dosage form.
- Standard Operating Procedure management.
- Instrument performance reports - to enable early diagnosis of any potential requirement for maintenance work and ability to look at yield etc.
- Double signature of all processes as recommended by the FDA part 211.
- Pre-production checks prompts to ensure that certain actions such as cleaning of the synthesis apparatus, checking of the tubing, reaction vessels, purification columns and other materials have been undertaken as recommended by the FDA.
- Different security levels based upon qualifications/levels of expertise.
- Multi site deployment - ideal for PET Manufacturing facilities that have multiple sites.
LabLogic will be at booth 1810 at the SNM meeting for one-to-one consultations about PET professionals individual cGMP needs.