HALIX offers QP services for certification of each drug product batch
EU directive 2001/83/EC (Medicinal products for human use) states that each batch of medicinal product must be certified by a qualified person (QP) before it can be released for sale or supply. This has been extended to cover clinical trial materials in EU Directive 2001/20/EC. The QP is legally responsible for certifying that the batch of drug product is safe to use and meets all required specifications.
A QP assesses whether any changes in manufacturing or QC tests can impact product quality and/or safety, and as such are an essential part of the pharmaceutical manufacturing chain.
HALIX Full Service Offering
HALIX employs several expert QPs. With their wide range of experience they can not only certify and release final product, but they can also help you in setting the specifications required for later release of a safe and efficacious drug.
Having the expertise of a QP close to where the manufacturing is done, can save you significantly in cost in your own QA resources. Every GMP batch that we manufacture is accompanied by a Certificate of Compliance (CoC) and a Certificate of Analysis (CoA).