The Central Drugs Standard Control Organization (CDSCO) has framed draft guidelines on good distribution practices for biological products for ensuring quality and traceability of biological products through all stages of distribution process.
The guideline, published for the feedbacks from the stakeholders, will apply to all companies involved in storing and distributing biological products at any stage including manufacturers of bulk products, finished products and wholesalers as well as suppliers, procurement organisations, donor agencies, certifying bodies, providers of logistic support, traders, transport companies and forwarding agents.
The GDP principles outlined in the guideline would be applicable to biological products as they move forward in the distribution chain (from the manufacturer to the entity dispensing the product to patients) as well as backwards (as a result of the return or recall).
Stakeholders have been asked to forward their comments within 15 days on the draft guidelines that were published on September 17.
According to the guidelines, all entities involved in the distribution chain need to have well defined organisational structures in place, with the responsibility, authority and the inter-relationship of all personnel clearly identified. All personnel involved in distribution activities should be adequately qualified, trained in accordance with standard operating procedures and their competence assessed through written training programmes. Companies would have to maintain a record of all such training programmes, including details of the subjects covered and the participants trained, according to the guidelines.
The guidelines also stipulate biological product distributors to establish and maintain a quality system with written procedures for all activities to ensure that a safe, transparent and secure distribution system is in place allowing product traceability.
Different aspects like premises, warehousing and storage (in accordance with good storage practices), temperature, environment and stock control (as per conditions stated on the product's label), transportation (in accordance with the storage conditions), containers, packaging and labelling (to prevent contamination and ensure proper handling of the product), temperature control during transportation (e.g. thermal packaging or refrigeration), dispatch and receipt of products (by persons or entities authorised to deal with such products), documentation (records to be maintained for one year after product expiry), and handling of complaints (distinguishing between complaints about the biological product, its packaging and distribution) are to be fixed as per the guidelines.