The European Commission Health and Consumers Directorate-General has issued the draft “guidelines on the principles of good distribution practices (GDP) for active substances for medicinal products for human use”. The EC is now seeking comments on the same from the pharma and biotech industry by April 30, 2013.
Industry experts stated that India already has 161 US FDA, 90 MHRA, and 1,000 WHO GMP approved world-class manufacturing facilities and the EC guidelines will be an extension of good practices that they are already familiar with. Therefore companies here will see no issues in compliance.
The guidelines call of focus on distribution of active substances during the procuring, import, supplying or exporting. It also highlights re-packaging, re-labelling or dividing up of active substances. Under the quality norms, the distributors of active substances should develop and maintain a good system based on processes and risk management principles, stated EC.
The quality system should be adequately resourced with competent personnel with suitable premises, equipment. The size, structure and complexity of distributor’s activities should be taken into consideration when developing or modifying the quality system.
With regards to personnel, a management representative should be appointed at each distribution point, for ensuring that a quality system is implemented and maintained. Key personnel involved in the warehousing of active substances should have the appropriate ability and experience to guarantee that active substances are properly stored and handled. Personnel should be trained in relation to the duties assigned to them, stated the EC guidance.
The regulatory authority also insists that the documentation should be made available on request of competent authorities. Electronic documentation should comply with Chapter 5.4 of Part II of Eudralex, the Rules Governing Medicinal Products in the European Union. Where active substances are procured from a distributor of active substances, the distributor should be registered according to Article 52 (a) of Directive 2001/83/EU.
Further, the guidance also calls for written procedures to describe the different operations which may affect the quality of the active substances. This covers the distribution activity, receipt and checking of deliveries, storage, cleaning and maintenance of the premises including pest control.
In addition all details of storage conditions, security of stocks on site and of consignments in transit, withdrawal from saleable stock, records, including records of clients orders, returned products, recall plans, etc. should be maintained. These procedures should be approved, signed and dated by the person responsible for the quality system, stated the regulatory authority.
The records should be made at the time each operation is undertaken and in such a way that all significant activities or events are traceable. The records should be clear and be retained for a period of five years at least.
Besides, records should be kept of each purchase and sale, showing the date of purchase or supply, name of the active substance, batch number and quantity received or supplied, and name and address of the original manufacturer. Documents that should be retained and available include: identity and address of original manufacturer along with purchase orders, bills of lading, transportation and distribution records, receipt and manufacturer’s batch number.
The premises and equipment should be suitable and adequate to ensure proper conservation, protection for instance narcotics and distribution of active substances. Even the monitoring devices, where used, should be calibrated, stated the guideline.