Do you need an experienced Qualified Person to conduct QP batch certification or to assist in optimising your batch review process? 

Welcome to our website! Here at Paul R Palmer Limited, we're passionate about batch release in the UK and Europe. As a qualified person (QP) with years of experience in the industry, we are excited to share with you some insights into the world of batch release and QP certification in the UK.

Let's start by defining what batch release means. Simply put, it's the process of ensuring that a batch of pharmaceuticals or medicinal products meets the required standards before they can be released to the market. This is critical to ensure that patients receive safe and effective treatments.

All batches of pharmaceutical products require certification by a Qualified Person in accordance with Eudralex volume 4, Annex 16 for clinical and commercial supply of pharmaceutical products within the UK & throughout Europe.

The systems and processes in place to govern the batch review process must be effective and robust as well as being efficient and suitable for your company's operational needs.

I am an experienced QP with a strong background in sterile manufacturing and the ability to identify the potential for improvements within existing systems to optimise processes whilst ensuring ongoing compliance.

You can get in touch via the contact us form, email, telephone or WhatsApp to discuss the support or assistance your company needs.

QP certification in the UK

In the UK, the responsibility for batch certification lies with the QP. To become a QP, you must hold a QP eligibility certificate in the UK. This is a legal requirement and is awarded by one of the professional bodies and behalf of the Medicines and Healthcare Products Regulatory Agency (MHRA) after a rigorous assessment process.

A QP, makes sure that each batch of pharmaceuticals or medicinal products meets the necessary standards before certification and subsequent release. This includes evaluating the manufacturing and testing processes, as well as verifying that the product has been manufactured in compliance with Good Manufacturing Practice (GMP) guidelines.

 

At Paul R Palmer Limited, we understand just how important batch release and qualified person certification is in the UK. That's why we offer consultancy services to help pharmaceutical companies navigate the complex regulatory landscape. Our services include QP support, GMP compliance, batch release support, training and advice.

In summary, batch release is a crucial part of the process in ensuring the safety and effectiveness of pharmaceuticals and medicinal products. With QPs with extensive experience, we are here to offer expert guidance on all aspects of batch release and QP certification in the UK. Don't hesitate to get in touch to learn more about how we can help you achieve your regulatory compliance goals.