GMP Audit Check List- 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?
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
a. General condition?
b. Integrity of containers?
c. Spillage?
d. Possible deterioration?
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,
a. Receiving document number?
b. date of receipt?
c. date of releasing?
d. date of expiry, if any?
e. Supplier?
f. Manufacturer?
g. Manufacturer's batch number?
h. Internal identification number?
i. type and size of containers?
j. Number of containers and their conditions?
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?
b. Are those of different colors?
c. Are there the following information on the labels:
- Name of materials?
- batch number?
- Analysis number?
- date released/rejected?
- Retest date/expiration date?
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?
b. Are there sampling plan and procedures?
c. Are there the following information on each sample taken:
- Name of person who performed the sampling.
- Quantity of samples taken.
- Number of containers sampled.
date of sampling.
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?
(First Expiry First out-FEFO) or (First Approved First Out )FAFO
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?
Are materials stored off the floor?
Are the materials stored under suitable environmental conditions?
Are inventory cards periodically reconciliated?
If a discrepancy is found, is it recorded and justified?
Is the discrepancy and justification documented with a explanation?
Raw materials and packaging materials,
a. If the identity or condition of a container of raw materials or packaging materials is suspicious or does not comply with requirements,
- is the container delivered to the quarantine area?
- is the disposition of the material determined by the Quality Control unit?
b. Are rejected materials consciously identified, segregated from approved materials and stored in the restricted and assigned area for rejects?
c. Are rejected materials destroyed or immediately returned to the supplier?
( Describe arrangement for disposal and destruction record)
d. Are printed packaging materials,
- stored in a restrictive storage area?
- dispensed under strict supervision?
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
a. General condition?
b. Integrity of containers?
c. Spillage?
d. Possible deterioration?
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,
a. Receiving document number?
b. date of receipt?
c. date of releasing?
d. date of expiry, if any?
e. Supplier?
f. Manufacturer?
g. Manufacturer's batch number?
h. Internal identification number?
i. type and size of containers?
j. Number of containers and their conditions?
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?
b. Are those of different colors?
c. Are there the following information on the labels:
- Name of materials?
- batch number?
- Analysis number?
- date released/rejected?
- Retest date/expiration date?
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?
b. Are there sampling plan and procedures?
c. Are there the following information on each sample taken:
- Name of person who performed the sampling.
- Quantity of samples taken.
- Number of containers sampled.
date of sampling.
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?
(First Expiry First out-FEFO) or (First Approved First Out )FAFO
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?
Are materials stored off the floor?
Are the materials stored under suitable environmental conditions?
Are inventory cards periodically reconciliated?
If a discrepancy is found, is it recorded and justified?
Is the discrepancy and justification documented with a explanation?
Raw materials and packaging materials,
a. If the identity or condition of a container of raw materials or packaging materials is suspicious or does not comply with requirements,
- is the container delivered to the quarantine area?
- is the disposition of the material determined by the Quality Control unit?
b. Are rejected materials consciously identified, segregated from approved materials and stored in the restricted and assigned area for rejects?
c. Are rejected materials destroyed or immediately returned to the supplier?
( Describe arrangement for disposal and destruction record)
d. Are printed packaging materials,
- stored in a restrictive storage area?
- dispensed under strict supervision?
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