Explore how ICS’ pharmaceutical warehousing can help ensure therapies remain in the best condition:
- What is pharmaceutical warehousing?
- Distribution
- ICS’ solution
- Why ICS?
What is pharmaceutical warehousing?
In alignment with good distribution practices (GDP), our pharmaceutical warehousing focuses on clean and safe pharmaceutical storage. We keep our pharma warehouse tidy and well-lit, with temperature controls for product safety.
Our pharmaceutical storage facilities have sanitation programs to prevent contamination. We manage cleaning materials carefully in our pharmaceutical distribution warehouse, ensuring no risk to products.
Shipping areas in our warehouse for pharmaceutical products are weather-protected. We control access to quarantine areas using advanced pharmaceutical storage systems. This helps us avoid mix-ups and maintain accurate inventory as part of our effective pharmaceutical storage and distribution strategy.
We dedicate specific areas within the facility for hazardous items, enhancing safety in our pharmaceutical warehousing and distribution processes. Our staff's wellbeing is a priority alongside product safety.
Pharmaceutical storage facilities must also follow serialization standards. The standards require drugs to be sorted into lots and given a unique barcode for traceability. Drugs must also be labeled as rejects, under quarantine, or approved for shipping to ensure only safe units are sent to patients.
The challenges of pharmaceutical warehousing
Companies face several challenges. They must ensure their pharmaceutical warehouses are fit for purpose and meet strict rules.
Pharmaceutical storage and distribution facilities must have processes in place capable of the following:
- Keeping storage areas clean with adequate space for all items to be kept in good condition without damage to inventory
- Making facilities easy to access for maintenance and inspection. They should have enough space for operators to move, and proper lighting and ventilation
- Temperature control to keep products at ambient, refrigerated, frozen, deep frozen, and cryogenic temperatures
- Security features to prevent unauthorized entry and handling of units, and to minimize the risk of theft
- Inventory systems designed to ensure the traceability of drugs in line with serialization and track and trace regulations
- Systems capable of providing comprehensive documentation for regulatory compliance.
- Enabling transfer of boxes and pallets into and out of the facility.
Expertise is vital. It ensures pharmaceutical warehousing meets these needs well, efficiently, and effectively.
Distribution is complex, and growth is critical
ICS’ distribution expertise
The ICS pharmaceutical storage and distribution service offers companies a range of benefits:
We are the first pharmaceutical 3PL provider to achieve certification, and we did it 18 months before the deadline.
ISO 9001:2015 certified as recommended by DQS Inc.
We help you achieve results across your commercialization journey by ensuring full regulatory compliance
- DEA licensed distributor/importer
- EPA compliant
- C-TPAT certification
- FDA licensed distributor
- cGMP/PDMA compliant
- CFR Part 11 compliant
- State Board of Pharmacy licensed
- National Association of Boards of Pharmacy (NABP)
- SOC 1 compliant
Why ICS? Your comprehensive third-party logistics partner
Foreign trade zone solutions
Manufacturer commercialization strategy
National reach to support your growth
Peace of mind when unexpected challenges arise
Value beyond distribution
Secure supply chain – 3PL Drug Quality and Security Act (DQSA) support
Meeting serialization needs with scalable solutions shaped by expertise and knowledge
For years, we've been a trusted partner for manufacturers in navigating Drug Supply Chain Security Act (DSCSA) regulations within our pharmaceutical warehousing environment. Our integration with leading serialization data providers ensures compliance with DSCSA traceability requirements.
Before products arrive at our warehouse, serial data files are rigorously validated. During outbound order processing, products are scanned and validated against this data, generating required outbound serial data transmitted to the manufacturer's customers.
Manufacturers receive copies of all outbound shipments from our warehouse, ensuring complete traceability information in their serialization repository. We have robust procedures for investigating and resolving any customer-reported exceptions, giving manufacturers confidence in successfully fulfilling DSCSA mandates.
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Pharmaceutical warehousing: FAQs
The U.S. FDA requires pharmaceutical warehousing to adhere to cGMP.
Good pharmaceutical warehousing practices under cGMP guidelines include maintaining cleanliness and temperature control, ensuring organized storage with clear labeling, implementing robust security measures, and providing proper handling training for staff. Regular inspections are conducted to ensure compliance, and detailed records of all activities are kept. These practices aim to prevent product contamination or damage, ensuring the safe distribution of pharmaceuticals
Regular cleaning of facilities and inspection of infrastructure and stored drugs minimize the risk of chemical or biological contamination of therapies, for patient safety. Cryogenic temperature control may also be needed to make sure sensitive products, such as cell and gene therapies, are kept at appropriate cold temperatures to maximize shelf life.
Processes should also be in place to safeguard products from counterfeiting or theft. Appropriate security measures prevent unauthorized access, while serialization data management systems can ensure all product units are tracked as they enter and leave the facility.
On their way to patients, therapies must be stored in warehouses until they are ready for use. Poor storage can lead to loss from wasted product or harm to patients from out-of-date drugs.
Pharmaceutical storage facilities are specifically designed to safeguard drug products from damage or premature breakdown, ensuring their effectiveness is maintained. These facilities serve as a crucial link in the pharmaceutical storage and distribution chain, providing secure environments that prevent counterfeiting and disruption to the supply process. They act as an intermediary between production and delivery to patients, holding pharmaceuticals in optimal conditions until they're ready for distribution.