Warehouse Cleaning to GDP Standards

Warehouse Cleaning to UK Good Distribution Practice Standards

Warehouse cleaning is an essential part of maintaining good distribution practice (GDP) standards for the storage and transportation of pharmaceutical products.

GDP ensures the quality, safety, and security of medicinal products throughout the pharmaceutical supply chain. It involves the removal of dust, dirt, debris, and any potential contaminants that could affect the integrity or efficacy of the products. In this blog post, we will discuss some of the key aspects of the cleaning process which will aid compliance with GDP standards in the UK.

Why is it important for GDP?

Warehouse cleaning helps to prevent the risk of contamination. This occurs when cleaning is not sufficiently carried out. Dust and other contaminants can permeate the medicinal products rendering them unacceptable to customers. The floor of the premises can kick up a lot of airborne particles due to activity on the ground, much of which is not visible. This can then be carried towards all levels of the warehouse by required air circulation equipment and settles upon everything, stock included. The stock could of course be cleaned carefully, but this is a lengthy process and places further risk upon the stored products.

Other factors to consider are Air and Temperature Control equipment. These are notorious for collecting dust. (Filters would need to be replaced regularly, but this is a site maintenance task for specialist servicing, and not something the cleaning staff are expected to do.)
Check the surfaces including pipework and cable conduits. Older suspended lighting units such as flourescent tube holders are also dust traps.

How to clean a warehouse according to GDP standards

A written procedure should specify the frequency, methods, equipment, materials, and personnel involved. The procedure should also include the following elements:

• Risk assessment: This involves identifying and evaluating the potential hazards and sources of contamination in the warehouse, and determining the appropriate level of cleaning required for each area.

• Cleaning plan: This involves defining the objectives, scope, schedule, and responsibilities for each area. The plan should also specify the methods (such as sweeping, vacuuming, wiping), equipment (such as brooms, brushes, mops, or machines), materials (such as detergents, disinfectants, or water), and quality checks (such as visual inspection) to be used.

• Cleaning records: This involves documenting the cleaning activities and results for each area and product type. The records should include the date and time of cleaning, the name and signature of the person who performed the cleaning, the cleaning method and equipment used, the materials used, any deviations or problems encountered during the cleaning process, and any corrective actions taken.

• Cleaning validation: This involves verifying that the cleaning procedure is effective and consistent in achieving the desired level of cleanliness for each area. The validation should be based on subjective inspection after cleaning. The RP must sign off the cleaning record.

What Cleaning Products?

As is the case with hospitals, clinics and other medical facilities, you must not use any cleaning products that leave a film behind on the surfaces, that are perfumed, or that have a strong bleach base, or are composed of waxy/oily substances. Most household products are not suitable. There are commercial graded cleaning agents available specifically for non-taint cleaning in medical facilities.

Using cleaning agents that would typically leave “a nice fragrance” cannot be used, due to the risk of contaminating the medical products. A virilent lemon-scented floor cleaner for example can leave a  trace odour on many products in storage, particularly near the floor level. This could be picked up by a receiving customer on the goods and they may reject the consignment.

NEVER use air fresheners of any kind, fly sprays (see our Pest Control course for details), or de-odourisers in the storage facilities.

Some Best Practices

Some best practices for warehouse cleaning are:

• Follow the written procedure and plan.
• Use appropriate personal protective equipment (PPE) such as gloves, masks, goggles, or aprons when handling stored products and cleaning materials. (Ensure you do not touch or handle medicinal products with PPE gloves that may be wet with cleaning fluid!)
• Move products and substances safely to one side while cleaning a storage area such as a shelving compartment or location. Pay attention to their required storage conditions, where you move them to, and place them back into their correct location as they came off the shelf (i.e; keep an eye on the First-Expiry-First-Out system).
• Do not mix bleach-based products (for lavatories) with acidic or ammonia-based cleaners. Fumes can result which can endanger human life.
• Label and store cleaning materials well away from medicinal products in a lockable room or suitable storage facility.
• Dispose of waste materials, spent fluid containers and consumables responsibly, safely and securely.
• The training of staff on warehouse cleaning procedures and practices must be regarded as necessary as Good Distribution Practice training for all other staff.
• Review regularly the warehouse cleaning procedures and plans, updating or amending where necessary.

Conclusion

Cleaning your Warehouse is a vital part of ensuring GDP compliance for the storage and transportation of medicines and their active ingredients. It helps to prevent cross-contamination, degradation and damage.

Cleaning should be done according to a written procedure that includes risk assessment, cleaning plan, and cleaning validation. All cleaning actions must be documented. It should also follow some best practices such as using PPE, segregating cleaning products, labelling materials, and disposing of waste properly. By following these guidelines, warehouse operators can ensure that they maintain high standards of quality, safety, and security for their products. An auditor or inspector from the MHRA will be able to see immediately if the premises are being neglected.