Contrôle produit fini calcium vitamine D3

Quality Control
1

Bonjour,
SVP quelqu’un peut m’aider ! jai effectué le contrôle du produit fini conformément à la procédure de contrôle mais c’est non conforme, quand j’ai sous traité chez un autre laboratoire c’est conforme ? quelles sont les techniques qu’il ne faut pas négligé ?

2

Do you want to say that…(I have translated in English. Please check and provide more explanation)

Did you mean: SVP quelqu’un peut m’aider ! j’ai effectué le contrôle du produit fini conformément à la procédure de contrôle mais c’est non conforme, quand j’ai sous traité chez un autre laboratoire c’est conforme ? quelles sont les techniques qu’il ne faut pas négligé ? meaning in English

3

Please someone can help me! I have checked the finished product in accordance with the control procedure but it is non-compliant, when I have subcontracted to another laboratory it is compliant? what are the techniques that should not be overlooked?

4

Please verify the following aspects at your laboratory and Contracted laboratory,

  • Please ensure that your laboratory and contracted Laboratory has correctly follwed analytical method.
  • Ensure that the analytical method is properly validated by your laboratory and correctly transferred to the contracted laboratory according to “Technology transfer” peorotocl / SOP.
  • Esure that during method validation, the parameters of “Robustness & Ruggedness” are considered (to ensure that there is no adverse effect of change in laboratory and change in instrument’s parameters, reagents, solutions in the analytical results).
  • Suggested that initial samples of your product batch are analysed jointly by your analyst and contracted laboratory analyst to ensure that there are no errors.
  • Also please ensure that there are no errors made at your laboratory.
  • Ensure that samples are kept at required storage conditions, because vitanin D3 is unstable at high temperature.
  • A thorough investigation should be carried out by contracted laboratory according to Out of Specification laboratory results (OOS investigation) SOP.
  • Contracted laboratory must be audited and assessed to ensure that they are compliant to GLP requirements (Good Laboratory Practice).
  • Ensure that all the anlytical steps, reagents, solutions, instruments (calibrated) used by laboratoy are correct.

With the above actions, it is possible to find out root cause of failure of analytical results in your laboratory.

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