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No white-out is permitted in GMP facilities and no gel pens (specific producing devices are selected in your SOPs and working Guidelines)This area is applicable only for orphan medicines. Required information on particulars and technique are present in “European Fee guideline on areas of the appliance of Write-up 8 of Regulation (EC) No 141/2000:

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The review needs while in the EU PQR for MA versions, currency of technological agreements, and also the postmarketing commitments tend not to mirror The everyday market practice for PAR/PQR, and there have been sector comments that Many of these review prerequisites appeared to be exterior the scope of the PQR. The review requirements for MA and p