5 Storage Conditions Essential for Pharmaceuticals

Think about all of the time, money, and care you invest in your pharmaceutical products throughout the R&D process. How terribly unfortunate it would be if damage from sub-optimal storage conditions kept them out of the market.

Alas, regulations for such important concerns as hygiene, temperature, labelling, quarantine, and documentation are too frequently ambiguous, unenforced, or worst of all, simply ignored.

In search of smart standards and guidelines for drug storage conditions, we consulted the Federal Drug Administration (FDA) and World Health Organization (WHO) for their recommendations. We’re hitting the highlights here, so be sure to visit their websites for more details.

HYGIENE

At the very least, storage areas for pharmaceutical products must be clean, dry, and orderly. More specifically:

• They must be free from infestation by insects, rodents, birds, and any other type of vermin.
• Receiving and dispatch bays are best if designed to protect products from moisture damage caused by inclement weather.
• Drugs should be stored off the floor and suitably spaced to permit cleaning and inspection.
• Handling procedures in the storage area must ensure that risks of contamination, mix-ups, and cross-contamination are kept to a minimum.

TEMPERATURE

Appropriate manual or automatic temperature recording devices are your best bet for keeping your pharmaceutical products within acceptable temperature limits.

• Locate monitors in areas most likely to show temperature fluctuations.
• Inspect and calibrate monitoring devices at scheduled intervals.
• Review temperature monitoring data monthly to determine trends or recurring issues. Data mapping should show uniformity of temperature across the storage facility.
• Keep monitoring records for at least the shelf-life of the product or as required by state and federal regulations.

LABELLING

Storage containers should be clearly labelled with all relevant information, including but not limited to:

• Name of the product
• Quantity
• Expiration date
• Name and address of supplier
• Batch number
• Date of receipt
• Recommended storage conditions (e.g., temperature, humidity)

DO NOT use unauthorized abbreviations, names or codes.

QUARANTINE

Storage areas must have physically separate spaces reserved and clearly marked for products that are:

• Rejected, expired, recalled, or returned
• Damaged, deteriorated, misbranded, or adulterated
• In immediate or sealed secondary containers that have been opened

Products so identified should be quarantined away from other pharmaceuticals until they are destroyed or returned to their supplier. Access to quarantine areas must be restricted to authorized personnel.

DOCUMENTATION

Documenting all activities in your storage areas is time worth investing. Maintain inventories and records for:

• All deliveries and dispatches
• The handling of expired stock
• The identity and quantity of the drugs quarantined and destroyed
• The route of materials and information in case of a recall

Read our White Paper.

You can learn more about the importance of monitoring storage conditions by consulting our White Paper, The Importance of Temperature Monitoring for Medication Safety & Efficacy. Please download it here.