GMP04

Good Manufacturing Practice for the Warehouse

The warehouse plays a crucial role in a medicinal products factory. This module explains the requirements of Good Manufacturing Practice (GMP) for the warehouse, and how to comply with them.

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 session we discuss procedures for the receipt of inward goods and outline how the goods are checked, recorded and labelled, quarantined, sampled and tested, and released for use or rejected. In the third session, we describe good practice for storage, inventory control, and transfer of materials and products to and from production. Finally, we discuss dispatch of finished products, and procedures for dealing with returned or recalled products.

Approved by the Royal Society of Chemistry for purposes of continuing professional development.

Approximate Course Time: 1.5 hours

Level: Introductory/Intermediate

CPD Points: 1.5

Audience: Manufacturing personnel

Category: GMP/QA/QC

Region: USA, Europe, Other

Who will benefit from this module?

This module 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.

Learning objectives

  • Comply with the requirements of Good Manufacturing Practice for the warehouse
  • Carry out the tasks and checks necessary when receiving goods
  • Follow good practice for storage and inventory control
  • Carry out the tasks and checks required for dispatch of finished products
  • Deal appropriately with returned or recalled products

Module outline

Module overview – An outline of the module’s scope and objectives, and notes on terminology.

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, labelled, 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 release and dispatch of finished products from the warehouse. We also outline procedures for dealing with returned products and for recall of products.

Assessment – Multiple-choice mastery assessment.

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