Good Manufacturing, Good Laboratory or Good Clinical Practice regulations all apply to laboratory testing, but they each serve different purposes with responsibilities being handled by different people.  In this first of three brief articles, we look at the role of GMPs.

Good Manufacturing Practice (GMP)
If you are in the business of manufacturing and selling finished regulated products - including food, drugs, medical devices and cosmetics - you need to demonstrate to market regulators such as the MHRA, EMA or FDA that each individual batch or ‘lot release’ that rolls off the production line has been manufactured in a safe environment and in accordance with the pre-defined specifications contained in the Marketing Authorisation (MA) issued by the regulator.  This is done to reduce possible contamination and manufacturing errors and is particularly important within the field of drug development, as even small errors can lead to serious consequences for patients.

GMP testing of products and ingredients takes place in a purpose-built laboratory facility that is designed and equipped to carry out testing within a Quality Control (QC) system of approved Standard Operating Procedures (SOPs).  In the laboratory this system of QC and SOPs determines whether or not the product or sample being tested meets manufacturing specifications.  

In Europe each batch of finished product must be certified by a ‘Qualified Person’ (QP) before being released for sale or supply in the EU or for export.  Certification can only be performed by a QP of the Marketing Authorisation Holder (MAH), i.e. the manufacturer and/or importer, who will ensure all quality tasks are completed according to GMP regulations.  To ensure this, manufacturers use a Quality Management System (QMS) to integrate and streamline quality processes.  This ensures the materials they receive reach the required level of quality and nothing falls through the cracks. 

Various stages of product manufacturing are often completed across multiple sites, including supply chain partners such as testing laboratories.  QPs have access to complete documentation for all supply chain activities involving the product right up to the stage of certification, and provided that all suppliers comply with GMP guidelines, the QP can certify the batch of finished product for release to the market.

Ultimately the responsibility for the safety, quality, and efficacy of a regulated product lies with the MAH.  However, the QP is responsible for ensuring that each individual batch has been manufactured and checked in accordance with the MA and with the GMPs.  

Failure to adhere to GMP regulations can lead to serious consequences such as product recalls, reputational damage, hefty fines, or even imprisonment.

Hoeford is GMP-certified and can assist with ‘lot release’ toxicology testing.  Contact us to find out more.