WAREHOUSE INSPECTION CHECKLIST (AS A DRUG DISTRIBUTOR)

PROVISIONS

PERSONNEL REFERENCE/S
1. Adequate number of qualified personnel at storage site/warehouse. WHO Annex 5 TRS 908
3.1
2. Proper training for personnel in relation to good storage practice, WHO Annex 9 TRS 908
regulations, procedures and safety (including drivers handling TTSPPs) 3.2 / WHO Annex 9
– including training records. TRS 961 12.1
3. Proper training of personnel and observance of high levels of personal WHO Annex 9 TRS 908
hygiene and sanitation. 3.3
4. Wearing of suitable protective appropriate for activities the personnel WHO Annex 9 TRS 908
perform. 3.3
5. Assigned personnel for checking of incoming deliveries against a
relevant purchase order (e.g. container, label description, batch WHO Annex 9 TRS 908
number, type of material or product quantity, uniformity of 5.7, 5.8, 5.9
containers).
PREMISES, WAREHOUSE, AND STORAGE REFERENCE/S
1. Presence of precautions to prevent unauthorized persons from WHO Annex 9 TRS 908
entering storage areas. 4.1
2. Sufficient area to allow orderly storage of products (products in WHO Annex 5 9.3 /
quarantine, rejected, returned, or recalled products). WHO Annex 9 TRS 4.2
3. Should be designed or adapted to ensure good storage conditions.
4. Should be clean, dry (within humidity requirements), and maintained
within acceptable temperature limits.
WHO Annex 9 TRS 908
5. Should be clean, free from accumulated waste, and vermin.
4.2
6. Storage of products: off the floor (on plastic pallets) and suitably
spaced to permit cleaning and inspection.
7. Pallets are kept in good state of cleanliness and repair.
8. Availability of a written sanitation program indicating the frequency of
cleaning and the methods to be used to clean the premises and WHO Annex 9 TRS 908
storage areas. 4.3, 4.4
9. Availability of written program for pest control.
10. Design of the receiving and dispatch bays should be appropriate to
protect products from the weather. WHO Annex 9 TRS 908
11. Reception area should be designed and equipped to allow incoming 4.5
containers of products to be cleaned, if necessary, before storage.
12. There should be an area segregated for the storage of quarantined,
rejected, expired, damaged, recalled, returned, counterfeit, or
suspected counterfeit products (should be separated from each other, WHO Annex 9 TRS
and all locked in) with proper labeling 4.8, 4.13
13. Quarantined products in the area should be clearly marked and access
restricted to the authorized personnel only.
14. Pharmaceutical products should be handled and stored in such a
WHO Annex 9 TRS 908
manner as to prevent contamination, mix-ups, and cross-
4.11
contamination.
 15. Products should be appropriately arranged and rotated to ensure that
WHO Annex 9 TRS 908
products due to expire first are sold and/or distributed first (first
4.12
expiry/first out (FEFO)).
16. Storage areas should be provided with adequate lighting to enable all WHO Annex 9 TRS 908
operations to be carried out accurately and safely. 4.16
17. Storage conditions should be in compliance with the recommendations WHO Annex 9 TRS 908
of manufacturer or instructions on the label of the product. 4.17
18. Temperature monitors should be located in areas that are most likely WHO Annex 9 TRS 908
to show fluctuations. 4.18
VEHICLES AND EQUIPMENT REFERENCE/S
1. Availability of dedicated vehicles and equipment, where possible, WHO Annex 5 TRS 957
when handling the products. 10.4
2. During use of non-dedicated vehicles and equipment, there should be
WHO Annex 5 TRS 957
available procedures in place to ensure that the quality of the product
10.5
will not be compromised.
3. Vehicles, containers, and equipment should be kept free from rodents,
vermin, birds, and other pests.

a. Equipment chosen and used for the cleaning of vehicles should

not constitute a source of contamination; agents used for the WHO Annex 5 TRS 957
cleaning of vehicles should be approved by management. 10.10, 10.12, 10.13
b. Special attention should be paid to the design, use, cleaning,
and maintenance of all equipment used for the handling of
products which are not in a protective shipping carton or case.
4. Availability of cleaning records.
RECORDS/DOCUMENTATION REFERENCE/S
1. Availability of recorded temperature monitoring data for review.
WHO Annex 9 TRS 908
2. Monitoring records should be kept for at least the shelf-life of the
4.18
stored product plus one year.
3. Records of calibration of temperature monitors/monitoring of WHO Annex 9 TRS 908
equipment should be kept. 4.19
4. Records should be kept for each delivery with description of the goods WHO Annex 9 TRS 908
(name of source, batch number, expiry date, quantity, quality) 5.3
5. Records should be maintained showing all receipts and issues of WHO Annex 9 TRS 908
materials and products according to a specified system. 5.4
6. There should be periodic stock reconciliation (actual stocks vs. WHO Annex 9 TRS 908
records). 5.14
7. Investigations should be done when significant stock discrepancies are WHO Annex 9 TRS 908
discovered (should be properly recorded and filed). 5.15
8. Availability of proper documentation prior to the dispatch and
WHO Annex 9 TRS 908
transport of products (delivery order, invoices, receipts, stock transfer,
7.8
material replenishment plan).
9. Presence of dispatch records readily accessible and available on
request (stating at least: the date of dispatch; the customer’s name
WHO Annex 9 TRS 908
and address; the product description, e.g. name, dosage form and
7.8
strength, batch number and quantity; the transport and storage
conditions).
 10. Availability of an established dispatch procedure taking into account
WHO Annex 9 TRS 908
the nature of the materials and products concerned and any special
7.5
precautions that might be required.
11. Availability of procedures in place to ensure that the integrity of the WHO Annex 5 TRS 957
products is not compromised during transportation. 10.6
12. Availability of procedures in place for the operation and maintenance
WHO Annex 5 TRS 957
of all vehicles and equipment involved in the distribution process,
10.9
including cleaning and safety precautions
13. Availability of procedure to ensure the required storage conditions for
products is maintained within acceptable limits during transportation; WHO Annex 5 TRS 957
personnel responsible for the transportation of products should be 13.3-13.5
informed about all relevant conditions for storage and transportation.
14. Availability of written procedure for investigating and dealing with any WHO Annex 5 TRS 957
failure to comply with storage requirements. 13.7
15. Availability of written procedure for spillage to prevent possible WHO Annex 5 TRS 957
contamination, cross-contamination, and hazards. 13.10
PRODUCTS REFERENCE/S
1. Products should be registered with FDA and compliant to labeling
RA 3720 / RA 9711
requirements (CPRs, notification approval).