IMP management services

IMP Services

Our IMP management suite is able to handle compounding of various dosage forms:

• Sterile products for parenteral administration including intravenous (iv), intramuscular (im) and subcutaneous (sc)
• Non-sterile products such as: capsules, solutions, suspensions and topicals
• Radiopharmaceuticals
• Solutions for inhalation/nebulisation

Additionally, our IMP services can include:

• Primary and secondary packaging
• Double-blind randomisation and code break envelope production
• Annex 13 compliant IMP label design
• Storage (ambient, refrigerated, -20°C, -70°C)
• GDP-compliant IMP distribution to external sites
• Reconciliation, return and destruction of IMP
• Procurement of comparator products and NIMPs

Regulatory expertise and compliance

Our IMP management suite is GCP-compliant for efficient handovers of products from the IMP suite pharmacy to our in-house Clinical Pharmacology Unit (CPU).

We also adhere to full Good Distribution Practice (GDP) for external distribution of your IMP. This ensures the product is fully safe, compliant and ready for your study.

We can aid with compliance submissions and facilitate rapid contact with the appropriate Regulatory Health Authorities, Ethics Committees and Notified Bodies during the development and maintenance phase of your clinical trials.

Our Qualified Persons (QPs) can aid with declarations, the certification of IMP batches, and the compliant importation of IMPs into the UK.

Qualified Person services

IMP management services also include Qualified Person (QP) services. Our QPs have extensive experience in handling IMPs and can support your company’s goals – whether you’re a manufacturer or sponsor.

Under IMP management, our QP services include:

• QP certification of IMP batches
• QP Declarations
• Importation of IMP from outside of the UK
• Importation of IMP from an approved country (QP Oversight).
• IMPD writing and review
• Quality oversight
• CMC consultancy
• Supply chain audits

Handling IMPs

All IMP is handled within our access and temperature-controlled GMP facility, under the guidance of our Head of IMP Management.

The facility includes a Grade C environment for the manufacture of non-sterile IMP and a Grade A positive pressure isolator for the aseptic preparation of sterile IMP.