The Importance of GMP
Failing to adhere to all the requirements of Good Manufacturing Practice (GMP) within a life sciences business can be catastrophic for all interested parties, patients, employees, and shareholders alike and include loss of life as well as punitive fines. This blog will detail who needs to understand GMP and provide some course recommendations to get you started.
So, who in your organisation needs a good basic understanding of GMP to ensure the organisation is both fully compliant and does everything within its gift to prevent a disaster occurring? The answer must be anyone who has any exposure to your warehousing, manufacturing, testing, or packaging facilities and processes.
How do you ensure that your staff possess a sound understanding of GMP relevant to their individual responsibilities to ensure the Identity, Strength, Purity and Quality (ISPQ) of your products? We can take the ‘heavy lifting’ out of this task with our range of professionally designed and developed GMP training programmes covering the various settings and facets of GMP.
We offer a range of courses covering GMP, you can find a selection of the courses we have available below:
An Introduction to Good Manufacturing Practice for Medicinal Products (GMP01). This module provides an ideal induction and refresher course in the basics of GMP. We begin by explaining what GMP is and why it is necessary. We then set out its main principles. Finally, we focus on two aspects of GMP that apply to everyone in the manufacturing environment: hygiene, cleaning, and sanitation; and documentation.
Good Documentation Practice (GMP02). Good Documentation Practice (GDocP) is that part of GMP that applies to the creation, maintenance, use, and retention of documents to provide assurance of the quality of products. In this module, we emphasise the crucial importance of GDocP and we identify five principles that underpin it. We explain the functions of the various types of documents that are used and discuss how they should be created and controlled. Finally, we set out requirements for record keeping – how data are to be entered into records, corrected if necessary, and how records must be retained.
Good Manufacturing Practice in Cleaning and Sanitation (GMP03). Cleaning and sanitation of premises and equipment are essential to efforts to prevent contamination of product, and they need to be done in compliance with Good Manufacturing Practice (GMP) regulatory requirements. This module shows why it is so important to do a good job, what to consider before and during each job, and how best to go about the work. We begin by explaining how product may become contaminated and what can be done to prevent contamination through effective cleaning and sanitation procedures. We set out good practices to keep the factory clean and sanitary, and we describe how to prepare for and carry out cleaning and sanitation of premises. Finally we turn to the vitally important subject of cleaning and sanitising of production equipment.
Good Manufacturing Practice for the Warehouse (GMP04). 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.
Good Manufacturing Practice in Processing Medicinal Products (GMP05). Operations in the dispensary and on processing lines are at the heart of medicinal product manufacturing. This module describes how to carry out such operations in compliance with the requirements of Good Manufacturing Practice. We discuss how to: dispense starting materials; set up, control, and record formulation processes; evaluate product yield and calculate materials reconciliation. We set out the Good Manufacturing Practice (GMP) requirements that must be met in carrying out these tasks.
Good Manufacturing Practice in Packaging Medicinal Products (GMP06). Packaging for medicinal products is subject to Good Manufacturing Practice rules similar to those for the products themselves. In this module we describe the functions that packaging must fulfil and the quality controls that are applied to packaging materials and operations. We set out the requirements for control of printed materials. We describe preparation, in-process control, and completion of a packaging run. Finally, we explain how to carry out reconciliation of packaging materials.
Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture (GMP07). A company’s Corrective and Preventive Action (CAPA ) system establishes how personnel should deal with manufacturing problems that have occurred or that may occur if not prevented. This module explains the principles of corrective and preventive action and describes typical CAPA procedure. It goes on to introduce root cause analysis and outline the role of progress tracking, escalating, and trending of CAPA procedures.
All the above courses have been accredited with CPD points by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom.