India Drafts GDP Guideline Aimed to Protect Drug Supply Chain
Drugmakers must appoint a responsible person at each of their distribution sites to implement and maintain a quality system that conforms to good distribution practices, according to a draft guideline from India’s Central Drugs Standard Control Organization.
The new controls are intended to prevent the introduction of fake or substandard drugs by ensuring all parts of the pharmaceutical supply chain involved in distribution conform to national GDPs.
The draft guideline focuses on the necessity for written procedures and requirements for the entire supply chain — from warehouse personnel to shippers and distributors and labeling companies — that can be verified by Indian drug regulators.
Records on the sale and distribution of pharmaceuticals should include, at a minimum:
- Date of dispatch;
- Complete business name, address, type of entity responsible for transportation, telephone number and contact names;
- Complete business name, address and status of the addressee, such as whether it’s a retail pharmacy, hospital or community clinic;
- Description of the products including name, dosage form and strength;
- Number of containers and quantity per container;
- Applicable transport and storage conditions;
- Unique number to allow identification of the delivery order; and
- Assigned batch number and expiration date.
The records must ensure traceability in the event a batch or entire product needs to be recalled. And companies should not ship medicines that are close to their expiration date because of the increased likelihood they might be outdated and ineffective when administered or consumed. Adequate segregation must be provided for the storage and transport of rejected, expired, recalled and returned products, the draft states.
The guideline also outlines what written procedures should look like for recalls and returns.
Unauthorized distributors and pharmaceutical sales also are a concern, the draft notes. Drugmakers must ensure that an adequate number of personnel are deployed at the various levels of the supply chain to guarantee the integrity of their storage and distribution plans.
Distributors are expected to self-audit their quality systems and initiate corrective and preventive measures when deficiencies are identified. The audits should be conducted by a designated, competent person “in an independent and detailed way,” according to the draft.
Inspection, auditing and certification of compliance with a quality system, such as the applicable International Standards Organization series or national or international guidelines by external bodies, is recommended, the guideline states.
For information on all aspects of GDP preparedness, visit FDAnews’ GDP Summit. — Zachary Brennan