The consultancy service offers expertise in analytical development and validation, including the review of drug product specifications and technical reports. Mark can also perform audits of GMP laboratories, assist with data integrity compliance and help to solve problems during analytical development.
Where companies lack the time or in-house expertise to audit GMP contract laboratories, Mark Powell Scientific can undertake this work on their behalf. In addition to the suitability of the quality management system, we are able to assess the competence of a laboratory’s technical management and staff. An audit plan is agreed with the client in advance and the findings of the audit are communicated promptly in a written report.
A number of high-profile cases of fraud in the reporting of test results for pharmaceutical products has led to a regulatory focus, in both the US and Europe, on data integrity. As an experienced pharmaceutical analyst and administrator of laboratory data systems, Mark Powell can help companies to meet regulatory requirements by performing an audit of relevant policies and practices. The audit, which covers every step in the analytical process from sampling to reporting results, is followed promptly by a written report which details the findings of the audit and recommends corrective actions.
Analytical Method Development and Troubleshooting
Mark Powell Scientific can advise on suitable sample preparation methods and initial chromatographic conditions for challenging sample types. Problems with analytical methods can cause costly delays to product development programmes or failure to meet regulatory expectations. All stages of analysis, including sampling, sample preparation, instrumental analysis and data processing, may introduce errors or unacceptably large variability into the test results. It is often possible to identify potential problems by conducting a technical review of method documentation; we also offer hands-on support at the bench for both development and troubleshooting.
Mark Powell is an experienced manager of analytical development programmes for small-molecule drug products, including solid, semi-solid and liquid oral dosage forms, and topical creams, gels and ointments. Many of the projects that he has worked on have been technically challenging, including very low dose solid oral formulations, combination drug products and oily formulations where the matrix has interfered with the extraction and analysis of the drug and its impurities. He has also worked on a number of extended-release and modified-release formulations. Services include specifying the scope and outcomes of analytical development activities, reviewing development and validation protocols/reports, drafting appropriate in-process and finished product specifications, and designing stability programmes to make the best use of available material.