Warehouse personnel needs to check the few points which are most important to identify before the audit. the following Audit Check List Points for the Warehouse in pharmaceuticals are given below.
Audit Check List Points for Warehousing / Distribution Area
- Are materials stored under containers as per the storage instructions on the label?
- Is there adequate space for the orderly storage of materials?
- Is there segregation of quarantined, approved & rejected materials?
- Are there separate stores for raw materials, packaging materials, labels, and finished products?
- Are materials stored on pallets, shelves, or racks, off the floor, and off the walls in all stores?
- Are minimum and maximum temperatures in the store recorded?
- Are air-conditioned and cold room facilities available?
- Are flammable and hazardous chemicals stored in safe conditions?
- Are there no expired raw materials in the raw material store(s)?
- Are materials dispensed according to the prescribed SOP meeting GMP requirements?
- After releasing by quality control, are raw materials and packaging materials released on a FIFO (first in first out basis?
- Do distribution records in the finished goods store enable specific batches to be traced?
- Ensure the availability of the approved vendor list
- Ensure the flycatcher is in working condition and there cleaning as per procedure in the given SOP.
- Is labeling proper on all containers?
Audit Check List Points for Warehouse for RM sampling Room
- Is RLAF cleaning done as per Procedure?
- Ensure the cleaning logs are updated with RLAF records.
- Ensure the vacuum cleaner is cleaned.
- Ensure all logbook is updated from sampling to cleaning.
- Ensure the cleaning of the Riser filter as per the procedure.
- Ensure daily cleaning of the area is done and the same should be updated on logbooks.
- Ensure daily verification and monthly calibration of weighing balance.
Each point of the checklist shall be filled as applicable and comments or remarks, in addition, shall be given under the remarks column in the checklist.
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Note: The points mentioned in this list are not limited to these only