India's Central Drug Standards Control Organization (CDSCO) issued the instructions last week in the final version of it guidance on good distribution practices (GDP) for biologic medicines.
The document – which replaces a draft version issued last month – makes clear all parties involved in the distribution of biologics are equally responsible for ensuring product quality, not just the manufacturers.
“It shall be the responsibility of all parties involved in the distribution of biological products to ensure that the quality of biological products and the integrity of the distribution chain are maintained throughout the distribution process from the site of the manufacturer to the entity responsible for dispensing or providing the product to the patient or his or her agent.”
To achieve this the CDSCO calls for collaboration between all parties, including government and law enforcement, and indicates that quality agreements should be in place for everyone involved in storage, transportation and distribution.
The regulator also insists that all involved have structures in place that clearly defined who is responsible at each stage of the distribution chain.
“An adequate organizational structure for each entity in the chain of distribution shall be defined with the aid of an organizational chart. The responsibility, authority and interrelationships of all personnel shall be clearly indicated. An organogram/ organizational chart shall be in place.”
Temperature control
Another key feature of the new guidance is its focus on controlling temperature during the distribution of biologics.
The CDSCO requires that validated temperature control systems – such as thermal packaging and refrigerated vehicles – be used to ensure that correct transport conditions are maintained between distributor and customer.
The guidance also sets out the various monitoring that is needed and urges distributors to consider seasonal climatic variations as part of this process.
“The process for delivery of sensitive products and control of seasonal temperature variations shall be described in a written procedure. This procedure shall also cover unexpected occurrences such as vehicle breakdown or non-delivery. A procedure shall also be in place for investigating and handling temperature excursions.”