Post Manufacturing Surveillance (PMS)

Procedures and Forms for Receiving Cold Chain Complaints and/or Samples:

1 – Cold Chain Complaints:

The sending agent should fill in the following data along with the fridge tag temperature record sheet and the period of temperature deviation to allow for assessing the products’ usage.

After evaluating the sent complaint, the PMS Department will send the result or the number of samples needed (if product analysis is required) back to the sending agent.

2 – Upon sending samples, please follow these instructions considering samples and the accompanying documents:

  1. The expiry date of samples must be valid till the end of the analyzing tests.
  2. Samples must have been confiscated on site and appropriately sealed during delivery to assure that they were not manipulated during transportation.
  3. The samples must be transported from site to the department in an appropriate cold chain to assure that they will be received in the same condition in which they were confiscated.

The person delivering the samples to the PMS department must have the following documents:

  1. An official document from the site in question that acknowledges that he/she is the one responsible for delivering these samples.
  2. The Form for Sample Sending (أورنيك/استمارة ارسال عينات).
  3. An official confiscation report that contains:
    1. -The reasons for confiscating these samples.
    2. – The storage condition in which they were found at the time of confiscation.
    3. – The product information (name, number of units sent, batch number, expiry date and whether they are opened or closed).
    4. – Description of the samples’ packaging.

After analysis, the results are sent back to the sending agent.

Please note that the PMS Department only assesses products previously registered by the NORCB and that it is only responsible for retesting and evaluating a product’s permissibility for use; it is not the body responsible for taking or implementing measures that deal with what is to be done with the product after analysis.

 

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