Good Manufacturing Practice for the Warehouse
Learn the requirements for complying with Good Manufacturing Practices in a medicinal manufacturing warehouse setting.
Overview
Keeping a well-maintained and organized warehouse for medical products is crucial for ensuring consumer safety and alignment with Good Manufacturing Practices (GMPs). This course explains the requirements of Good Manufacturing Practice (GMP) for the warehouse, and how to comply with them. The course provides essential training for all personnel who work in the warehouse of a medicinal products manufacturer. Other staff working in a manufacturing environment in the pharma/biotech industry will also benefit from this module.
We begin with an introduction to work in the warehouse of a medicinal products manufacturer, in which we describe the kinds of goods that come in and go out and how they may be stored in a typical layout. We identify methods of segregating stock, and we set out seven main goals of GMP for the warehouse. GMP for the warehouse overlaps with Good Distribution Practice (GDP), which applies to the whole distribution chain for products.
In the next section, we discuss procedures for the receipt of inward goods and outline how the goods are checked, recorded and labeled, quarantined, sampled and tested, and released for use or rejected. In the third section, we describe good practices for storage, inventory control, and transfer of materials and products to and from production. Finally, we discuss the dispatch of finished products and procedures for dealing with returned or recalled products.
The course covers:
- Working in the warehouse – In this session we provide an introduction to work in the warehouse, in which we describe the kinds of goods that come in and go out and how they may be stored in a typical layout. We identify methods of segregating stock, and we set out seven main goals of Good Manufacturing Practice (GMP) for the warehouse. Finally, we mention a few types of document that are important to warehouse personnel.
- Receipt of inward goods – The warehouse’s control of stock begins with the receipt of inward goods. Materials offloaded at the reception bay need to be checked, identified, labeled, recorded, and quarantined by warehouse personnel; they then need to be sampled, tested, and released or rejected by the Quality unit. In this session, we describe what is required of warehouse personnel in receiving inward goods.
- Storage – Goods released for use by the Quality unit need to be stored in such a way that they will not suffer contamination, degradation, or damage, will not be incorrectly picked, and can be located and used well before their expiry date. In this session, we discuss good storage practices, including control of inventory, good housekeeping, issue of materials to production, and control of printed materials.
- Dispatch, returns, and recalls – In this session we describe the release and dispatch of finished products from the warehouse. We also outline procedures for dealing with returned products and for recall of products.
Agenda
- Module Overview
- Working in the Warehouse
- Receipt of Inward Goods
- Storage
- Dispatch, Returns, and Recalls
- Additional Resources
- Assessment