Pharmaceutical or medical products are subjected to various risks at different stages in the supply chain, for example, purchasing, storage, repackaging, relabeling, transportation and distribution. Various people and entities are responsible for the handling, storage and distribution of these products.
As per WHO,
The whole process of storage and distribution of medical products should have a comprehensively designed, documented and correctly implemented quality system that incorporates GSP (Good storage practice), GDP (Good distribution practice), principles of quality risk management and management review.
The quality system should ensure that:
- GSP and GDP are adopted and implemented to ensure that the quality of medical products is maintained throughout their shelf life in the supply chain; and medical products are appropriately procured, stored, distributed and delivered (in compliance with the legislation) to the appropriate recipients;
- Operations are clearly specified in written procedures;
- Responsibilities are clearly specified in job descriptions;
- All risks are identified and necessary, effective controls are implemented;
- Processes are in place to assure the management of outsourced activities;
- There is a procedure for self-inspection and quality audits;
- There is a system for quality risk management;
- There are systems for managing returns, complaints and recalls; and
- There are systems to manage changes, deviations and corrective and preventive actions (CAPAs).
Premises and Personnel
- Premises should be suitably located, designed, constructed and maintained, to ensure appropriate operations such as receiving, storage, picking, packing and dispatch of medical products.
- There should be sufficient space, lighting and ventilation to ensure required segregation, appropriate storage conditions and cleanliness.
- Sufficient security should be provided and access should be controlled.
- Each incoming delivery should be checked against the relevant documentation, to ensure that the correct product is delivered from the correct supplier. This may include, for example, the purchase order, containers, label description, batch number, expiry date, product and quantity.
- The consignment should be examined for uniformity of the containers and, if necessary, should be subdivided according to the supplier’s batch number should the delivery comprise more than one batch. Each batch should be dealt with separately.
- Measures should be taken to ensure that rejected medical products cannot be used. They should be segregated and securely stored while awaiting destruction or return to the supplier.
- Storage areas should be of sufficient capacity to allow orderly storage of the various categories of medical products.
- Storage areas should be maintained within acceptable and specified temperature limits. Where the labels show special storage conditions are required (e.g. temperature, relative humidity), these should be provided, controlled, monitored and recorded.
- The storage conditions for medical products should be in compliance with their labelling and information provided by the manufacturer.
- Mapping studies for temperature, and relative humidity where appropriate, should be done, for example in storage areas, refrigerators and freezers.
- There should be an adequate number of personnel and they should have appropriate educational qualification, experience and training relative to the activities undertaken.
Documentation and Records
- Records of stock levels for all medical products in store should be maintained, in either paper or electronic format. These records should be updated after each operation (e.g. entries, issues, losses, adjustments).
- All stock should be checked at regular intervals, to identify those items that are close to their retest or expiry date. Appropriate action should be taken, such as removal of these items from useable stock.
- Documentation includes all procedures, records and data, whether in paper or electronic form. Documents should be appropriately designed, completed, reviewed, authorized, distributed and kept as required. Documents should be readily available.
Distribution and Transport
- Medical products should be transported in accordance with the conditions stated on the labels and described by the manufacturer. The risk to the quality of the medical product during transport and distribution should be eliminated or minimized to an acceptable level.
- Product, batch and container identity should be maintained at all times. All labels should remain legible.
- Distribution records should be sufficiently detailed to allow for a recall when required.
- Vehicles should be suitable for their purpose, with sufficient space and appropriately equipped to protect medical products.
- Appropriate environmental conditions should be maintained, monitored and recorded during transportation.
- Special care should be taken when using dry ice and liquid nitrogen in shipment containers, owing to safety issues and possible adverse effects on the quality of medical products.
- Written procedures should be available for the handling of damaged and/ or broken shipment containers. Particular attention should be paid to those containing potentially toxic and hazardous products.
- There should be documented, detailed procedures for the dispatch of products.
As per EMA,
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain. GDP also applies to the sourcing, storage and transportation of active pharmaceutical ingredients and other ingredients used in the production of the medicines.
Resource:
- WHO
- EMA
