In the context of this article, resources are warehouses, vehicles, and organizational personnel. Facilities, equipment, and transportation vehicles are emphasized as systems that function to control environmental conditions in accordance with product specifications.
Evaluation of facilities, equipment, packaging, and transportation systems should be part of the quality system of the organization. Sampling family or type of equipment/vehicles (e.g., shipping containers or trailers) should be part of the risk assessment, when evaluation of individual systems is not feasible. Additionally, trading partner facilities/vehicles can be evaluated by risk by family or type, which may include sample lane mapping to evaluate the exposure of product through the transportation system.
Storage
The facility should be designed to maintain the quality and integrity of the stored drug product. Buildings should be constructed in such a way that they are appropriate for the intended operations, taking into account:
- Security
- Product characteristics (e.g., narcotics, radiopharmaceuticals, fire/explosion risk)
- Product status (e.g., approved, recalled, returned, rejected, quarantined, falsified)
- Product required storage temperature
- Ease of cleaning and maintenance
- Logical flow of personnel and materials
- Means of preventing mix-ups and cross-contamination
- Ergonomic measures
- Product demand in order to prevent capacity constraints
- Any local, national, or international requirements
- Necessary environmental controls
Product segregation and proper identification can reduce the risk of mixing up products with different statuses, such as quarantined (rejected, expired, recalled, returned, or falsified) and released/salable. Products with special handling authorization, such as narcotics, should be segregated and locked in a secure area per applicable regulations. Radiopharmaceuticals should be contained in dedicated, locked storage areas. Hazardous products should be managed per applicable regulations for each supply chain partner.
Buildings and facilities used for the warehousing, storage, and/or holding of drug products should be of adequate size for their intended use to prevent product overcrowding. The building and facility should be designed to control environmental conditions, where necessary, and should be made of materials that are readily or easily cleaned. Sanitation and pest control procedures should be written, indicating the frequency of cleaning and the materials and methods to be used. The pest-control program should prevent contamination and ensure the safe use of pesticides. Records of all cleaning and pest-control activities should be maintained.
Storage facilities themselves, unless thermostatically controlled, cannot be validated. However, they can be qualified via a mapping process, with appropriate attention to geography and seasons. The generator backup power supply should be qualified.
Product storage areas/units should utilize recording systems to log and track temperatures. Alarm systems should be an integral part of the monitoring system for product temperatures. Although automated systems monitor units continuously, manual checks should be performed as appropriate to ensure functionality. When automated systems are not available, manual systems may be used. A risk-based approach should be applied when using a manual system.
Controlled access to warehouses and vehicles is a measure used to prevent unauthorized personnel from coming into contact with the product. Access control can be accomplished with automated systems or by procedure. Adequate precautions should be taken to prevent theft and diversion of products.
Transportation
All vehicles used in supply chain activities—such as trucks, vans, trains, airplanes, sea vessels, mail delivery vehicles, and emergency medical services vehicles—should be suitable for the intended purpose because they are providing in-transit storage and should prevent exposure to conditions that affect stability and package integrity. Thus, all of the precautions needed to maintain product quality, integrity, and security should be taken. Risk identification and mitigation strategies should be applied to determine whether the transportation method adequately protects the product from environmental exposures such as temperature and vibration without the need for additional packaging, or if additional packaging is necessary to mitigate the risk.
Personnel
Organizations should hire personnel and contractors who meet the requirements for handling drugs safely and securely per applicable laws and regulations. Job descriptions and individual profiles should be reviewed to ensure that all experience and training requirements are met and maintained.
Source:
- USP 〈1079〉
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