Qualified Person Services
Our Qualified Persons specialise in the certification of Investigational Medicinal Products and will bring a wealth of experience to your organisation whether you are a sponsor or manufacturer.
Batch Certification, Quality Oversight, IMP Management
As a manufacturer, you may find that to employ a full time, permanent QP is not cost effective, or you may be having difficulty recruiting. JWQC specialise in providing part-time Contract QP resource, bridging QP gaps, providing that extra level of expertise or providing extra resource at particularly busy times. We work with you to establish an on-site attendance pattern, acknowledging the flexibility you need to fulfil the necessary batch certification whilst understanding that we need to attend site with a frequency sufficient to allow us to be aware of the status of your Pharmaceutical Quality System.
Investigational Medicinal Product Specialists
As a sponsor, you need assurance that your IMP has been manufactured to GMP and in accordance with commitments you have made to the regulator. We have the necessary experience and knowledge to provide Quality Oversight of manufacturing operations at all your manufacturing partners from API manufacture, IMP manufacture, testing and clinical trial packaging.
Our experience, for batch certification of your products, covers sterile and non-sterile dosage forms including liquids, semi-solids, capsules and tablets, plasmids and proteins, freeze dried and spray dried presentations, cell-based and biotech products, and medical devices.
You can use our wealth of experience in your organisation to facilitate training, mentoring and education of staff.
Our contract QP services include:
- Batch certification of IMPs on manufacturer’s IMP license
- GMP audits and Quality oversight of IMP manufacture
- Provision of tools for a structured PSF to ensure IMP production is managed effectively