In an evolving supply chain landscape of pharmaceutical industry where it is becoming complex and challenging by the day, regulatory compliance is of utmost importance to ensure product integrity, data security and timely delivery of products to the patients. The Pharmaceutical supply chain involves several stakeholders including manufacturers, logistics suppliers, wholesalers, pharmacies and hospitals. Lack of coordination among these stakeholders can lead to operational inefficiencies, delays, or even product damage and shortages.
Supply chain challenges can deter growth and innovation of a pharmaceutical company by diverting its focus away from its core purpose of research and manufacturing of medicines. Majority of pharmaceutical companies therefore outsource the storage and distribution activities to third party logistics companies, commonly known as 3PLs. These are specialised suppliers that provides not just the transportation and warehousing services, but also inventory management and order fulfilment. 3PLs today play a vital role in the pharmaceutical industry by providing capability, tools, and resources to manage the movement of goods from manufacturers to end-users.
What are the good practices for storage and distribution of pharmaceutical products
Storage and distribution of pharmaceutical and health products require specialised knowledge and experience of logistics and supply chain. 3PL partners must possess strong regulatory expertise and should follow best practices when handling pharmaceutical products.
- Risk management: In the highly regulated pharmaceutical industry, supply chain activities including storage and distribution must be assessed for the risks involved and actions must be taken to mitigate the identified risks. Some of the activities requiring thorough risk assessment include transportation of products using different routes and vehicles, storage of products in certain environmental conditions in a warehouse, business continuity back-up plan for critical operations and changes to the computerised systems and buildings.
- Qualified facilities and equipment: All facilities and equipment like warehouses and temperature-controlled vehicles must be qualified for their intended use. Temperature monitoring and warehouse management systems must be validated to ensure consistency of data recording and reporting.
- Temperature control and security: Pharmaceutical products are intended to be used by patients and therefore it is crucial that the quality, efficacy and safety of the products are not compromised during the storage and distribution. Systems should be in place to control the environmental conditions (like temperature, humidity, light) and security of the products to avoid any adverse impact on the products.
- Quality management system: A robust quality management system is essential for maintaining compliance and meeting the expectations of customers and regulatory authorities. The system must ensure that every step of storage and transportation meets the highest standards of quality and standard procedures are used by trained and qualified staff when handling the pharmaceutical products. Certifications like ISO 9001 and ISO 13485 demonstrate the commitment of 3PL to quality.
- Supplier management: 3PLs routinely use services from specialised suppliers for temperature mapping, calibration, maintenance, pest control, security, cleaning and last mile delivery. All suppliers must be qualified for the suitability of the services provided, including conducting audits where risks to product quality are higher.
Key quality and regulatory compliance requirements for storage and distribution of pharmaceutical products
Pharmaceutical products must comply with health authority and other local regulations to ensure their safety, efficacy, and quality. These regulations vary by country and region, and they cover everything from manufacturing to packaging, labeling, storage, and transportation. 3PL providers managing the storage and distribution activities must comply with these regulations. Such commitments are often described in quality and contract agreements between pharmaceutical companies and 3PLs.
- Good Distribution Practices (GDP): GDP is an important compliance requirement in the supply chain management of pharmaceutical products. It requires products to be stored and transported under appropriate environment conditions, preventing risks of damage or contamination, documenting and recording of all activities, maintaining clean, hygienic, and suitable facilities and equipment. GDP requires procedures in place to manage product returns and recalls efficiently, and their adequate segregation.
- Good Manufacturing Practices (GMP): 3PLs when engaging in manufacturing activities and value-added services like importation, storage of manufacturing raw and intermediate substances, re-packing, labelling or sampling must comply to GMP by establishing a comprehensive quality management system. An independent QA/QC department with responsibility for quality oversight must be established in the organisation.
- Anti-Counterfeit: A counterfeit pharmaceutical product is more likely to enter the supply chain during storage and distribution and can harm the health of a patient. Anti-counterfeit regulations (like the Falsified Medicines Directive of the EU and Drug Supply Chain Security Act of US) require responsible companies to establish systems and procedures to detect and report counterfeit products.
- Safety and Environment Regulations: Every 3PL handling pharmaceutical products or hazardous materials is required to implement appropriate management systems focused on workplace health, safety, and environmental protection. Certifications like ISO 14001 and ISO 45001 demonstrate the commitment of 3PL to meet these obligations.
While 3PLs provide the expertise and flexibility needed to meet unique requirements of pharmaceutical companies, they are at the same time expected to meet the strict quality and regulatory requirements related to storage and distribution of medicines. An excellent quality audit history, best in class facilities and industry best certifications are all indicators of a competent pharmaceutical 3Pl supplier.
To learn more, join Gurpal Singh on his course, Effective Regulatory Compliance for Pharmaceutical Storage and Distribution in Pharma Supply Chains
References:
WHO TRS 1025-Annex 7: Good Storage and Distribution Practices for Medicinal Products, Available at: https://www.who.int/publications/m/item/trs-1025-annex-7
EU Guidelines for GDP of medicinal products for human use, Available at: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/good-distribution-practice
Published on Oct 03, 2025 by