| Title: Storage & Distribution of Drug Products, Medical Devices and Related Materials | |||||
| Guidance Number: 073 | |||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Storage & Distribution of Drug Products, Medical Devices and Related Materials
Introduction
This document provides guidance the storage and distribution requirements for Drug Products, Medical Devices and related Production Materials from a GMP Site or Logistics Centers, and/or transported between manufacturing and Logistic Sites.
1. Storage Conditions for Drug Products should be based on stability studies.
2. Storage Conditions for Medical Devices and In-Process Materials should be based on stability studies or other experimental evidence approved by the Quality Team.
3. Warehouse Storage should provide for sufficient cleaning/inspection space behind pallets or racks. If warehouse storage area is insufficient for cleaning and inspection, materials should be moved so floors behind stored materials can be cleaned as needed, but at least once every three (3) months.
4. Warehouse Storage should provide for sufficient cleaning/inspection space behind pallets or racks. If warehouse storage area is insufficient for cleaning and inspection, materials should be moved so floors behind stored materials can be cleaned as needed, but at least once every three (3) months.
5. When Special Storage Conditions are Required, such as controlled humidity or refrigeration, recording monitoring devices and alarms should be used and maintained to ensure requirements are met.
6. Temperature Monitoring should be performed for products requiring special shipping conditions (e.g., refrigeration), unless there is documented rationale (e.g., historical records, stability data, shipping controls) for not monitoring such shipments.
7. Procedures for Shipping Between Locations for each product should address:
- Type of packaging to be employed;
- Labeling requirements;
- Mode of transportation; and
- Environmental conditions for shipment.
8. Preshipment Vehicle Inspections for Cleanliness and Integrity should be performed prior to loading any carrier with company products, in order to ascertain that the vehicle is free from:
- Dust, dirt, oil, grease, residue from previous loads, signs of pests, odors, or fumes;
- Holes in the roof, walls, or floor of the vehicle body, through which precipitation, pests, or foreign substances can gain entry; and
- Internal damage to the vehicle body with presence of splinters or metal projections.
- Vehicles not meeting the inspection criteria should not be loaded.
9. Security Measures for Incoming Carriers, whether carrying inbound drug products or medical devices or intended for outbound drug products or medical devices, should include:
- Driver identification and verification that driver is employed by carrier firm;
- Record made of carrier tractor and trailer registration;
- Driver provided escort if non-site employee, when entry into facilities is necessary; and
- Driver’s Order or Bill of Laden verified to match expectations.
- Additionally for full truckload shipments, the trailer seal number should be recorded and the seal’s integrity verified.