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What is GMP?      

Good manufacturing practices are a set of practices that are required in order to comply with industry standards and regulations.

GMP helps to minimise the risks involved in manufacturing product and helps ensure products meet quality standards.

GxP, cGxP and cGMP explainer

Often, a broader term is used in industry -GxP-where the “x” is used as an umbrella letter in representing different subjects or disciplines in industry.  For example GLP (Good Laboratory Practice) GDP, (Good Documentation Practice) and GEP (Good Engineering Practice) and GMP (Good Manufacturing Practices)

Furthermore, the use of a lower case “c” as a prefix indicates “current” or “up-to-date”.  So cGMP stands for “Current Good Manufacturing Practices. This means that some conventions or practices are subject to change within the industry. Therefore it is important to be up-to-date in the application of cGxP or cGMP.

Quality Assurance and Quality Control

The terms “Quality Assurance” and “Quality Control” get knocked around a lot both in regulated industries such as Medical Device and Pharmaceutical, but also in the wider world of general engineering and technology. However, for CGMP compliant companies, the two terms have different meanings.

Quality assurance works towards delivering products, be they medicinal or device in nature, are fit for their intended use. Quality Assurance therefore, principally involves the application of GMP within a company. The application of GMP and other principles is done or achieved by the Quality Management system.Therefore, GMP and Quality Assurance are closely related.

The term “Quality Control’ is generally more specific as it refers to the sampling activities, raw material and product specifications and testing. Quality Control is responsible for ensuring that product meets the relevant specifications. To facilitate Quality Control. The following conditions must be met:

-          Adequate facilities

-          Appropriately trained people

-          Proper sampling

-          Approved or validation test methods

Implementing GMP

A quality management system (QMS) is a collection of business processes that constitute good quality management concepts. The goal of such processes is to meet the aims and objectives set out in the Quality  Policy of a company.

Section 5.3 of ISO 9001 Quality Management System requires companies to have a defined and documented Quality Policy. The QMS is an important tool in achieving a compliant GMP environment within a company.

ISO 13485, the Medical Device Directive provides a framework and QMS for manufacturers of Medical devices, if the harmonised version of ISO 13485 is implemented in a company and certification is obtained it ensures that is it compliant with directives pertaining to manufacture of medical devices in a GMP environment.

For further information, visit the below FDA website pages below, our check out our ebook guide to cGMP here.

For Pharmaceutical Quality/Manufacturing Standards (CGMP)

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064971.htm

For Quality System (QS) Regulation/Medical Device Good Manufacturing Practices

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