GMP – Good Manufacturing Practice. GMP is a system of rules and regulations to ensure that products are produced and controlled according to prescribed quality standards. Unless you meet the GMP requirements of your industry, your products are essentially banned from the market. Through GMP qualification, you demonstrate that the quality of your products is consistent, reproducible and controlled.
For manufacturers of pharmaceuticals, GMP qualification of their production facilities is one of the core quality management goals. GMP is not a new invention and qualification has long been a key requirement for companies seeking production licenses. As GMP qualification is essentially a quality assurance mechanism, it is becoming ever more popular in the food and cosmetics industries.
We are highly experienced in this area and would be delighted to assist you in devising your own qualification strategy. We help you compile the necessary documentation and support you in assessing your plants, machines, premises and IT systems.
Four steps to successful qualification
With a GMP qualification, you prove that your technical equipment is suitable for the intended purpose and works perfectly, producing items that fully meet the relevant quality requirements.
The actual qualification process consists of four steps that need to be fully documented for approval by the relevant authorities.
- Design Qualification, DQ
- Installation Qualification, IQ
- Operational Qualification, OQ
- Performance Qualification, PQ
For GMP qualification, all four steps need to be completed in sequence.
Our team at your side
To obtain GMP qualification for a new plant, you need to submit a large number of documents, proofs, technical specifications, etc. This is not only time-consuming, but can also be quite stressful. Our qualification team deals exclusively with qualification procedures and would be delighted to assist you. Together with you, we can devise an efficient qualification strategy that saves you money.
Our strategies have proven highly effective, as have our templates and procedures. We make sure that your submission to the authorities is complete and well-presented. Where necessary, we adapt the layout of documents to meet your guidelines and requirements.
Mandatory in the healthcare sector
Pharmaceutical and medical technical companies are required by law to be GMP compliant. We assist you in the qualification process. Please contact us for a quote. We can offer you exactly what you need – from just the basics to meet the minimum regulatory standards to all-in-one packages for peace of mind. We support you throughout the qualification process. At every step, you decide which tasks are to be done in house and what you want to outsource to us.
Move to GMP in food&beverage industry
At the moment, GMP qualification is not yet mandatory for food&beverage producers. It is however seen as a great quality assurance tool and a cornerstone of comprehensive quality management. There are also first signs that the regulatory framework governing the pharmaceutical industry is gradually being extended to cover food and beverages.