Dispensing of raw material for tablet formulation

Production
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  1. what should be grade of area for dispensing raw material.
  2. which type of LAF used for dispensing.
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Class C at rest.
RLAF is used.

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LAF meaning

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Laminar Air flow

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Grade D is required since manufacturing of tablet products generally occurs in Grade D

The objective of weighing booth is not elevating the grade of dispensing area to be higher than preparation area

But the objective is dust containment and operator protection

The following is snapshot from 2018 WHO Annex 8

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The following is snapshot of WHO draft interpretation of Annex 8

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The following are links for full documents of both

https://apps.who.int/medicinedocs/documents/s23455en/s23455en.pdf

https://www.who.int/medicines/areas/quality_safety/quality_assurance/HVAC_Part2_QAS18-759-15022018.pdf

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C at rest
D at operational

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Grade D

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https://www.who.int/medicines/areas/quality_safety/quality_assurance/GMPSterilePharmaceuticalProductsTRS961Annex6.pdf

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I thought it must be grade A whatever the kind of medicine To be manufacturered because the raw materials dispensed will be used in other product thus To avoid contamination’s risk it s must be grade A??
I am looking eagerly for more expalanation mr.

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Grade A is used only in sterile product manufacturing

Please see my previous posts which include snapshots from guidelines and include links for the full documents of guidelines

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http://www.who.int/medicines/areas/quality_safety/quality_assurance/HVAC_QAS15-639_31082015.pdf

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Thanks Mr.

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Sir under RLAF area i think A class should be come. Whether we do dispensing for sterile or non sterile.

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