Warehouse Inspection Checklist (from Fda).docx

WAREHOUSE INSPECTION CHECKLIST (AS A DRUG DISTRIBUTOR) PROVISIONS PERSONNEL 1. Adequate number of qualified personnel at storage site/warehouse. 2. Proper training for personnel in relation to good storage practice, regulations, procedures and safety (including drivers handling TTSPPs) – including training records. 3. Proper training of personnel and observance of high levels of personal hygiene and sanitation. 4. Wearing of suitable protective appropriate for activities the personnel perform. 5. Assigned personnel for checking of incoming deliveries against a relevant purchase order (e.g. container, label description, batch number, type of material or product quantity, uniformity of containers). PREMISES, WAREHOUSE, AND STORAGE 1. Presence of precautions to prevent unauthorized persons from entering storage areas. 2. Sufficient area to allow orderly storage of products (products in quarantine, rejected, returned, or recalled products). 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. 5. Should be clean, free from accumulated waste, and vermin. 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 storage areas. 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. 11. Reception area should be designed and equipped to allow incoming 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, and all locked in) with proper labeling 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 manner as to prevent contamination, mix-ups, and crosscontamination.

REFERENCE/S WHO Annex 5 TRS 908 3.1 WHO Annex 9 TRS 908 3.2 / WHO Annex 9 TRS 961 12.1 WHO Annex 9 TRS 908 3.3 WHO Annex 9 TRS 908 3.3 WHO Annex 9 TRS 908 5.7, 5.8, 5.9 REFERENCE/S WHO Annex 9 TRS 908 4.1 WHO Annex 5 9.3 / WHO Annex 9 TRS 4.2

WHO Annex 9 TRS 908 4.2

WHO Annex 9 TRS 908 4.3, 4.4

WHO Annex 9 TRS 908 4.5

WHO Annex 9 TRS 4.8, 4.13

WHO Annex 9 TRS 908 4.11

15. Products should be appropriately arranged and rotated to ensure that products due to expire first are sold and/or distributed first (first expiry/first out (FEFO)). 16. Storage areas should be provided with adequate lighting to enable all operations to be carried out accurately and safely. 17. Storage conditions should be in compliance with the recommendations of manufacturer or instructions on the label of the product. 18. Temperature monitors should be located in areas that are most likely to show fluctuations. VEHICLES AND EQUIPMENT 1. Availability of dedicated vehicles and equipment, where possible, when handling the products. 2. During use of non-dedicated vehicles and equipment, there should be available procedures in place to ensure that the quality of the product 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 cleaning of vehicles should be approved by management. 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 1. Availability of recorded temperature monitoring data for review. 2. Monitoring records should be kept for at least the shelf-life of the stored product plus one year. 3. Records of calibration of temperature monitors/monitoring of equipment should be kept. 4. Records should be kept for each delivery with description of the goods (name of source, batch number, expiry date, quantity, quality) 5. Records should be maintained showing all receipts and issues of materials and products according to a specified system. 6. There should be periodic stock reconciliation (actual stocks vs. records). 7. Investigations should be done when significant stock discrepancies are discovered (should be properly recorded and filed). 8. Availability of proper documentation prior to the dispatch and transport of products (delivery order, invoices, receipts, stock transfer, 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 and address; the product description, e.g. name, dosage form and strength, batch number and quantity; the transport and storage conditions).

WHO Annex 9 TRS 908 4.12 WHO Annex 9 TRS 908 4.16 WHO Annex 9 TRS 908 4.17 WHO Annex 9 TRS 908 4.18 REFERENCE/S WHO Annex 5 TRS 957 10.4 WHO Annex 5 TRS 957 10.5

WHO Annex 5 TRS 957 10.10, 10.12, 10.13

REFERENCE/S WHO Annex 9 TRS 908 4.18 WHO Annex 9 TRS 908 4.19 WHO Annex 9 TRS 908 5.3 WHO Annex 9 TRS 908 5.4 WHO Annex 9 TRS 908 5.14 WHO Annex 9 TRS 908 5.15 WHO Annex 9 TRS 908 7.8

WHO Annex 9 TRS 908 7.8

10. Availability of an established dispatch procedure taking into account the nature of the materials and products concerned and any special precautions that might be required. 11. Availability of procedures in place to ensure that the integrity of the products is not compromised during transportation. 12. Availability of procedures in place for the operation and maintenance of all vehicles and equipment involved in the distribution process, including cleaning and safety precautions 13. Availability of procedure to ensure the required storage conditions for products is maintained within acceptable limits during transportation; personnel responsible for the transportation of products should be informed about all relevant conditions for storage and transportation. 14. Availability of written procedure for investigating and dealing with any failure to comply with storage requirements. 15. Availability of written procedure for spillage to prevent possible contamination, cross-contamination, and hazards. PRODUCTS 1. Products should be registered with FDA and compliant to labeling requirements (CPRs, notification approval).

WHO Annex 9 TRS 908 7.5 WHO Annex 5 TRS 957 10.6 WHO Annex 5 TRS 957 10.9 WHO Annex 5 TRS 957 13.3-13.5 WHO Annex 5 TRS 957 13.7 WHO Annex 5 TRS 957 13.10 REFERENCE/S RA 3720 / RA 9711