ARTICLES BY TIM SANDLE
FDA Releases Guidance On Drug Products Containing Nanomaterials11/18/2022
In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.
What’s All The Hype About mRNA Vaccinology?3/7/2022
The COVID-19 mRNA-based vaccine success is spurring a further stream of medicines to come. This article provides an overview of mRNA for those who aren't already working in the field, how mRNA is being used in vaccines, and how mRNA can be used for future developments.
3D Printing For Pharmaceuticals & Medical Devices: A Primer With Risk Considerations1/28/2022
Implementation of single-use technologies for pharma and medical device manufacturing has introduced advantages in terms of design, sterility assurance, and a reduction in energy usage. 3D printing can deliver precise measurements to production facilities. This article describes the 3D printing process, risk considerations, and limitations — but the future is bright.
Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications10/22/2021
While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices.
Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity8/18/2021
The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.
10 Critical Validation Parameters For Microbiological Experiments7/26/2021
In studying a microbiological method, different validation parameters require assessment. These are variables or factors that can be controlled, changed, or measured in the experiment. This article outlines the key parameters to consider.
What To Expect From A Remote Inspection -- & How To Navigate It7/23/2021
Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.
Best Practices For Designing Microbiology Experiments6/23/2021
A sound scientific approach can be taken for running experiments and qualification of microbiological methods. This article looks at factors to consider in drawing up assessment criteria for a microbiological test, including the limit of detection, specificity, and quantification.
A LIMS Audit Framework: What To Audit & How To Prepare5/24/2021
Laboratory information management systems (LIMS) are inevitably the subject of regulatory focus and audit. This article considers what to audit and how to audit a LIMS, presenting a framework useful to those planning to undertake a LIMS audit and for laboratory managers who need to prepare.
Are You Approaching LIMS Validation Correctly?4/26/2021
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.