freezer location

• Maira
  10/09/2020 01:12

  I have a difficult question. The building that houses our laboratory does not have a generator but our new office building does, and we will be moving into a new laboratory building with a generator in a year. Can we have samples for ADA analysis under GLP in our office building (3min walk away) until we move into our new space? we would check the samples in and out the same day we run the assay. Thanks!
• Colin Wilsher
  10/09/2020 07:26

  I assume that the GLP Commiitte has been asked?
• Maira
  11/09/2020 17:54

  Our internal GLP committee came up with this solution, I would just want to make sure that it is acceptable.
• Colin Wilsher
  11/09/2020 18:22

  Best to ask RQA GLP Commiitte
• RQA GLP Committee
  19/11/2020 13:50

  Dear Maira There are other things that need consideration, not just having the availability of the generator. Would this piece of GLP equipment be within the footprint of the GLP facility? Would it be monitored and maintained in line with GLP expectations? What is the potential for samples to be compromised? Are they secure in an office? What is the impact to the office environment? What about contamination? You should conduct a risk assessment and overall evaluation considering this solution along with other solutions and conclude the best solution to go with, and that you should document this as the rationale of your decision.

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