Deviation during simpling of the raw material

Quality Control
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if the bag of raw material is torn at the time of sampling, what is the procedure to follow?

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You can following course of actions to address this issue,

  • If the inner material remains unprotected due to torn raw material bag, replace this damaged bag with another bag in good condition and transfer the raw material in the new bag with the proper identification label.
  • Record this incident in the raw material sampling report/form.
  • If the bag is torn due to its poor quality inform the supplier about this incident.
3

thank you for your reply
who will be responsible for transferring the raw material to a new bag are they the quality control staff
if you have a reference please share it

4

Transferring of raw material should be done by a Warehouse person in presence of QA/QC to witness the activity. Appropriate line clearance should be certified by the QA person. This activity should be done in the Sampling/Dispensing room under LAF (Laminar Airflow unit) similar to the dispensing procedure of raw materials. The activity should be documented contemporaneously.

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5

Sir is it necessary to record such type of incident and why it is to be documented?)

6

Yes, please. Any incident or activity, or operation under GMP/GCP/GLP environment must be documented appropriately. This is a part of Data integrity. This provides evidence that the material transfer activity was performed in a controlled manner.

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  1. Clean up the area: Use gloves and clean up any spilled material, as well as any equipment or surfaces that may have come into contact with it.
  2. Determine the extent of the contamination: If the tear is small, it may be possible to still obtain a representative sample. If the tear is large or if there is significant contamination, it may be necessary to discard the entire bag and obtain a new sample.
  3. Take a new sample: If a new sample is needed, ensure that the sampling equipment is clean and free of any residual material. Use a clean, new sample bag to obtain a representative sample, taking care to avoid contaminating the sample.
  4. Label the sample: Label the new sample bag with the date, time, source, and any other relevant information to ensure that the sample can be properly identified and tracked.
  5. Quarantine the affected material: If the torn bag contains a significant amount of raw material, it may be necessary to quarantine it to prevent any potential contamination of other materials. This can be done by moving the bag to a designated area and securing it to prevent any further contamination.
  6. Document the incident: Document the incident in a log or report, including the date and time, the extent of the tear, the amount of material that was spilled or contaminated, and any steps taken to clean up the area and obtain a new sample.
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