Warehousing Audit Checklist for Pharmaceuticals
Introduction
A Warehousing Audit Checklist for Pharmaceuticals is a structured tool designed to ensure compliance with regulatory standards, Good Storage Practices (GSP), and operational efficiency in pharmaceutical warehouses. It helps identify potential risks, maintain product integrity, and prevent contamination or deviations. This checklist covers key areas such as temperature and humidity control, inventory management, security, documentation, and adherence to GMP (Good Manufacturing Practices). By conducting regular audits using this checklist, pharmaceutical companies can enhance quality assurance, improve regulatory compliance, and mitigate risks associated with improper storage, ultimately ensuring patient safety and product efficacy.
- Warehousing: Environment
1.1.1 Is the area neat, clean, and orderly?
1.1.2 Are environmental conditions monitored to ensure they are consistent with labelled storage conditions?
1.1.3 Is the equipment used for measuring and monitoring environmental conditions checked and calibrated at suitable intervals, and are the results of such checks recorded and retained?
1.1.4 Are there an adequate number of measuring probes sited in appropriate locations to provide a representative picture of the area?
1.1.5 Are the environmental records of all storage areas retained in compliance with GQP 18, and are they easily accessible?
1.1.6 Is there an adequate warning system to indicate if specified environmental conditions have not been maintained, and is there a written procedure specifying the action to be taken when this occurs?
1.1.7 Are any deviations from required environmental conditions brought to the attention of the quality organization?
1.1.8 Are all materials stored on pallets off the floor?
- Warehousing: Security
2.1.1 Is the area adequately protected against unauthorized entry?
- Warehousing: Goods Receipt
3.1.1 Is there a written standard operating procedure for receipt of all incoming materials?
3.1.2 Is this procedure available to all staff who need to follow it?
3.1.3 Does the receiving department have a written procedure that lists materials requiring special storage or handling instructions?
3.1.4 Are incoming materials off-loaded under cover?
3.1.5 Are containers appropriately cleaned prior to entry into the warehouse?
3.1.6 Does the receiving area have sufficient space for the orderly placement of all materials?
3.1.7 Are containers labelled with in-house labels in accordance with standard in-house written procedures?
3.1.8 Where several containers of the same batch of a raw material are received, is each container uniquely identified?
3.1.9 Is each delivery of each component regarded as a separate batch for sampling, testing, and release purposes?
3.1.10 Are deliveries examined for integrity of containers and possible contamination?
3.1.11 Does receiving inspection check incoming shipments of materials against the requirements of the purchase order?
3.1.12 Do the receiving records include a description of the goods, physical condition, quantity, supplier, supplier’s batch number, and date of receipt?
- Warehousing: Sampling Area
4.1.1 Is there a sampling area with appropriate environmental conditions?
4.1.2 Is there a detailed sampling procedure?
4.1.3 Is sampling equipment cleaned and stored in a satisfactory manner?
4.1.4 Are the containers which have been sampled appropriately identified?
4.1.5 Are containers adequately resealed after sampling?
- Warehousing: Storage Areas
5.1.1 Is the status of all materials readily identifiable at all times?
5.1.2 Is access to material storage areas restricted to authorised personnel?
5.1.3 Is there a First In First Out (FIFO) system for materials?
5.1.4 Are records maintained of stock issue, returns, and destruction which allow complete traceability of the usage of a batch?
5.1.5 If quarantined materials are not stored in a separate area, does the system adequately control the status, accessibility, and movement of quarantined materials?
5.1.6 Are materials adequately handled, identified, and stored to prevent damage, contamination, mix-ups, and loss?
- Warehousing: Printed Material Storage
6.1.1 Is the area used for storage of labels adequate in size, physical separation, and physical security?
6.1.2 Is the label/leaflet storage area controlled to ensure limited access by authorised personnel only?
6.1.3 Is the label/leaflet storage designed and operated to prevent mix-ups?
6.1.4 Is there a proper accountability system for all printed material?
6.1.5 Are different lots of labels clearly separated in storage?
6.1.6 Is there a written procedure specifying the restrictions on the authority of access to printed packaging materials?
- Warehousing: Distribution
7.1.1 Does a system exist by which the distribution of each lot of drug product can be readily traced to facilitate its recall if necessary?
7.1.2 Are the products transported in such a way that identification of the product is not lost, the product does not contaminate or is not contaminated by other products or materials, and the product and its pack are not subjected to adverse environmental conditions?
7.1.3 Do ‘released’ stickers bear the name of the company, the description of the material, the code number of the material, and a unique in-house identification number?
7.1.4 Are all dispatches made from an area which is dedicated to the storage of finished goods that have been released for sale?
7.1.5 Is there an effective system to control finished stock rotation (FIFO)?
7.1.6 Are the storage facilities and handling procedures adequate to maintain the quality of the product between final acceptance and shipping?
7.1.7 Is there a secure system which ensures that only product approved by the quality organisation is distributed?
7.1.8 Is there a secure system which ensures that expired product is not distributed?
7.1.9 Are contract carriers selected and monitored to ensure that their operations provide adequate security protection from pilferage or tampering?
- Warehousing: Rejects
8.1.1 Is there a written procedure to ensure that rejected materials are adequately controlled?
8.1.2 Do the handling systems ensure that reject materials will not be inadvertently used?
8.1.3 Are rejected materials disposed of promptly and securely?