The draft guidance document, issued by the Central Drugs Standard Control Organisation (CDSCO), aligns with the WHO Technical Report Series (TRS) on good storage and distribution practices for such products.
The guidelines are set to apply to all individuals and establishments engaged in any phase of the storage and distribution of pharmaceutical products, starting from the manufacturer’s facilities to the individual dispensing the products to a patient or their representative.
“Not of standard quality and spurious products are a significant threat to public health and safety. Consequently, it is essential to protect the supply chain against the penetration of such products,” reads the draft ‘Guidelines on Good Distribution Practices for Pharmaceutical Products’.
The document outlines measures to aid stakeholders in meeting their obligations at various phases within the supply chain to prevent the entry of ‘sub-standard’ products in the market.
The draft suggests incorporating self-inspections by a designated, competent individual in an independent and detailed manner within the ‘quality system.’All distributors of pharmaceutical products are required to create and uphold a ‘quality system.’ It further stated that a responsible individual must be designated by the management for every distribution site, with specified authority and accountability to ensure the implementation and maintenance of the ‘quality system.’The guidelines specify that any deviations from the approved procedures must be recorded and examined. It was mentioned in the guidelines that suitable corrective and preventive action (CAPA) should be implemented to rectify deviations and prevent their occurrence.
The document mentioned that if a product requires a recall, it should be separated during transportation and distinctly marked as ‘recalled products.’ In cases where segregation during transit is unfeasible, these items must be securely packaged, clearly labelled, and accompanied by suitable documentation.
All customers and competent authorities in all nations where a specific pharmaceutical product may have been distributed must be promptly notified of any plans to recall the product,
The returned products shall be destroyed in accordance with “international, national and local requirements” and with due consideration to protection of the environment unless it is certain that their quality is satisfactory, after they have been critically assessed in accordance with a written and authorized procedure, the document said.
Records for the dispatch of products should include a description of the products including name, dosage form and strength (if applicable), quantity, assigned batch number and expiry date, among other details.
It shall be ensured that records of dispatch contain enough information to enable traceability of the pharmaceutical product, the draft guidelines said.
(With PTI inputs)
