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GMP Audit Check Lis1-Storage of Starting Materials
GMP Audit Check Lis1-Storage of Starting Materials
GMP Audit Check Lis1-Storage of Starting Materials
Are there physically separated storage areas for - a. raw materials? b.Packaging materials
Are storage areas enclosed and locked, where required?
Is storage available for - a. solvent? b. Inflammable material?
Is there a quarantine for raw materials and packaging materials and finished products before release?
Is there a segregated area for rejected materials?
Are there separated areas for toxic substances, psychotropic agents and the like?
Is the area for storage of materials of adequate size?
Are warehouse lighting and ventilation adequate?
If there is a need for humidity and temperature control, are these regulated?
If so, are there humidity and temperature measuring instruments?
Are there written records for these data?
Is the possibility of entering insects, rodents, birds in the building completely avoided?
Is the warehouse adequately staffed?
Is there a proper supervision?
Have the personnel receive appropriate GMP training?
Do the personnel receive up-date GMP training? How often ?
Is each delivery visually checked on receipt for
c. Spillage?
Are there standard operating instructions and procedures available for handling of starting materials, packaging
materials, finished product, sampling, quarantine release/storage etc.
Is there a record on incoming goods, which includes the following information on,
e. Supplier?
f. Manufacturer?
Is there similar record for outgoing goods including delivering document number?
Is stock record maintained so that stock reconciliation can be made?
Are the starting materials labeled, including the name designated in the specification?
Is the disposition of the stock adequate to preserve the integrity and identity of the materials?
Quality Control Labels
a. Are there different labels each for quarantine, release and rejected?
Are quality control labels attached only by persons approved quality control?
Sampling
a. Are they performed by Quality Control or staff approved by Quality Control?
Are different batches within one delivery recorded as separate batches for sampling testing and release purpose?
Is each starting material used only after release for use?
Is there a stock rotation program?
Are samples taken for identification from every container to provide assurance that all containers in a delivery contain
the correct starting materials and are not mislabeled by the supplier?
Are deliveries of starting materials held in quarantine until approved and released for use?
Are stocks of starting materials
a. Inspected at intervals to ensure that the containers are properly closed and labeled and are in a good
condition?
b. reported in writing to quality control for sampling and retesting after a definite storage period of after exposure to air,
heat or other conditions that may adversely affect their quality?
a. If the identity or condition of a container of raw materials or packaging materials is suspicious or does not
comply with requirements,
b. Are rejected materials consciously identified, segregated from approved materials and stored in the restricted and
assigned area for rejects?