ARTICLES BY TIM SANDLE
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.
Complying With Batch Release: Auditing Electronic Batch Records3/26/2021
This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation.
Important cGMP Considerations For Implementing Electronic Batch Records2/26/2021
Mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met.
When Biopharma Automation Projects Fail: Averting Disaster1/25/2021
Automation does not always result in success, and poor automation can be as damaging to the pharmaceutical organization as no automation at all. This article addresses what happens when automation goes wrong and how mistakes can be avoided by adopting a risk-centric approach.