Self-inspection SOP

1. Self-inspection
SOP
uniPHARM Wholesale Drugs – GMP Manual V4.7

2. Self-inspection SOP
I. Self-inspections are to be conducted
by the personnel listed at Section
2.2.2, or an authorized deputy, in
accordance with the following
schedule (precise dates are to be
determined by the GMP Quality
Management Team)
SOP Schedule
Training Semi-annual
Receiving Semi-annual
Putaway/Storage/Cycle Counts Semi-annual
Shipping Semi-annual
Returns Semi-annual
Recalls Annually irrespective of the
occurrence of a ‘live’ recall
Maintenance of Storage
Equipment
Semi-annual
Records Semi-annual

3. Self-inspection SOP
II. A record of the occurrence, results, observations and recommendations for improvement of a
SOP is to be made on the appropriate SOP Self-inspection Log. results are recorded on the
appropriate Self-inspection Log and saved in Gauss.
II. All SOP Self-inspection Logs are to be signed (an electronic signature is acceptable) and dated by
the individual performing the inspection, saved in the SOP Self-inspection Log Folder located at
Q:SuperserverGMPGMP SOP Self-inspections, and referred promptly to the GMP Quality
Management Team for review and consideration of any recommendations.
II. All changes/corrective actions approved by the GMP Quality Management Team are to be
recorded on the appropriate SOP Self-inspection Log, together with a record of agreed
implementation requirements (including timeframe for completion). Changes are to be saved in
the appropriate log located at Q:SuperserverGMPGMP SOP Self-inspections.