GMP Development

GMP Development

Good Manufacturing Practice (GMP) is at the centre of what we do.

At High Force Research we have deliberately broken the journey down into component parts and we offer support and expertise in each area:

  • Stage 1: R&D quality level
  • Stage 2: Traceable quality level
  • Stage 3: GMP quality level

We understand that commercial needs often make it necessary to work to tight budgets or time scales, and can impact at what stage of your process we become involved, meaning that a flexible approach is required.

However, because we have a solid understanding of the full journey and are equipped to deliver a comprehensive service, we will never lose sight of the ‘big picture’. Understanding your timescale, budget and long term goals allows us to tailor the GMP journey without compromising regulatory requirements.

GMP services offered are:

Quality is at the heart of every aspect of the GMP manufacturing process. HFR‘s QA follows ICH Q7 and Eudralex volume 4 part II for clinical trials and has been continually inspected by the MHRA since 2005. Our dedicated Quality Assurance team ensure that SOPs, documentation and records are maintained. The group is also responsible for managing deviations that may occur during the manufacturing process and reviewing all documentation generated throughout the GMP manufacturing campaign.

On completion of process development High Force Research can manufacture an API under GMP guidelines as regulated by ICH Q7 and Eudralex volume 4 part II for clinical trials to support phase 1 human clinical trials. Ideally, a demonstration of the manufacturing route is completed to a ‘traceable’ quality standard to ensure the route is fit for purpose. API produced from this stage is typically used for late toxicology studies.

High Force Research has two ISO Class 8 clean room suites each having a change room, preparation room and manufacturing laboratory equipped with fume hoods, extraction arms and compressed air for breathing. The laboratory can cope with vessel sizes up to 30L with temperature control ranging from -40 to +150oC. Production is carried out by chemists trained in GMP SOPs and in project dedicated equipment to ensure there is no cross contamination between projects.

High Force Research has a dedicated analytical laboratory and team that provides analytical support throughout the GMP Journey. They are an essential part of the team developing analytical methods that meet customers’ and regulatory criteria. As well as testing incoming raw materials, analysis of in process samples and analysis and release of intermediates and APIs the team has the ability to develop and validate analytical methods for the following analytical techniques:

  • HPLC for chemical purity and impurity profile
  • Chiral HPLC
  • Residual solvents by GC, headspace or direct injection
  • NMR (Proton, Carbon, Fluorine)
  • Optical Rotation
  • KF Titration
  • FTIR
  • Heavy Metals Analysis
  • Counter ion analysis
  • Residue on Ignition

The following analytical techniques are routinely contracted out to a qualified, audited analytical house. The results are reviewed by our QC/QA teams:

  • Ion Chromatography
  • Trace metals analysis using ICP-MS or ICP-OES
  • Ion Chromatography
  • X-Ray Fluoresence
  • X-Ray powder diffraction
  • Particle Size
High Force Research are able to offer full or partial validation of test methods according to ICH guidelines Q2 (R1).

Identification, qualification of analyte and limit / quantification of impurities can be completed using a wide range of analytical techniques. You will be invited to approve the protocol before work starts and will receive a final report of all supporting analytical work and analytical methods upon completion.

At High Force Research we employ experienced auditors to assess suitability of third party contractors for API starting material manufacture or test facilities.

Suitability will be determined by an initial paper questionnaire followed by a full site audit. Auditors will assess the site against regulatory guidelines and formally report the findings to you in an audit report.

Stress testing of the drug substances can help identify the likely degradation products, which can in turn help establish the degradation pathways, intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures.

Forced degradation conditions include varying effects of temperature, humidity and where appropriate oxidation, photolysis and hydrolysis across a wide range of pH values. You, the client will be invited to approve the protocol before work starts, and will receive a final report, all supporting analytical work and analytical methods upon completion.

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.

Forced degradation of an API is routinely carried out as part of the stability study. Conditions include varying effects of temperature, humidity and where appropriate oxidations, photolysis and hydrolysis across a wide range of pH values.

If any of these services are of interest and you would like a detailed discussion, please contact Stella James.