What is GMP?
When a company has a licence to manufacture medicinal products, it is legally obliged to apply Good Manufacturing Practice (GMP). This is a set of best practices that are designed to assure that pharmaceutical products are consistently manufactured and tested to the highest standard. These practices minimise the risk that medicine is harmful e.g. contaminated, labelled incorrectly, or ineffective.
It is a regulatory requirement that products are manufactured in accordance with GMP standards. Most countries will only import medicines that have been manufactured to these internationally recognized standards. The standards are published by the regulatory authorities of each country.
In the EU, the requirements are published in the Eudralex Volume 4. They cover every aspect of the manufacturing and distribution lifecycle, from purchasing raw materials to handling complaints. The Competent Authorities in each EU member state oversee compliance with their respective countries by conducting regular inspections of the manufacturing sites.
Meanwhile in the UK, the requirements are published in the Orange Guide and are regulated by the MHRA. Following Brexit, the UK will be a third country and to export into europe, will have to assure that the GMP requirements applied are equivalent to EU standards.
The US requirements are documented in 21 CFR 210/211 and are overseen by theFood and Drug Administration (FDA). Compliance with these standards is essential in order to sell products in the US. Recently, the FDA have recognised the GMP Inspections performed by some EU Competent Authorities through Mutual Recognition Agreements.
While GMP practices are written for implementation in the pharmaceutical industry, they are also adopted and implemented by the medical device, cosmetic and food industries.
WHY IS GMP IMPORTANT?
GMP is an important assurance to patients that their products are made to a high standard. Poor quality medicines can be a hazard to patients and can result in costly product recalls and investigations.
In a GMP operation manufacturing processes are tightly controlled, personnel are highly trained, and the quality system assures that the correct checks and tests are performed.
The competent authorities of each member state regularly inspect manufacturing sites to assure compliance. Failure to comply can result in a regulatory citation or even suspension of operations.
What is cGMP?
The GMP regulations and the interpretation of them change and evolve with new knowledge, technology and with product and process understanding. The ‘c’ stands for ‘current’ and means that, even if the regulation is not updated, the manufacturer should ensure that the most current expectations are applied. This can be challenging but is enabled by following regulatory guidance; industry conferences, presentations, and publications; inspection & citation trends; and, of course, expert sites like this one!
What are the principles of GMP?
GMP practices are based on some underlying principles:
- Ensuring that facilities and equipment is well designed and suitable for use.
- That processes and testing are proven to be suitable and are controlled.
- That operations are performed by competent trained personnel.
- That processes are closely monitored to assure product quality.
- That records of the manufacture and testing of each batch are completed and retained.
In recent times, Quality Risk Management Principles are applied to assure that the extent of control applied is proportionate to the risks to quality.
Why do we need GMP auditing?
Every manufacturing site is audited periodically by the regulatory authorities of the countries to which it ships products. To avoid issues riding in these audits, facilities perform internal audits or self inspections. This is a requirement of the EU GMPs.
Every functional area in the operation is typically audited annually. Self Inspections should be performed by trained personnel that are independent of the area under audit. GMP Services offer in-house and remote auditing courses. To enquire email info@gmp.ie
Why do I need to become GMP certified?
It is a requirement of the GMP regulations that people working in pharmaceutical operations receive training when they join (induction) and on an on-going basis (refresher). This training is typically delivered annually in each manufacturing company. It is also an advantage when applying for a role in the pharmaceutical industry to have some basic GMP Training.
For more information on how we can help with your GMP training, please contact us. We offer GMP courses for all types of manufacturers and supporting services.