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.
- Top 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter In 2019
- Using Production And Postmarket Data To Validate FMEA Assumptions
- 3 Strategies To Address The Biggest Concerns Facing Generic Drug Makers
- An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report
- Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues
- 6 Things We Need From FDA Before Full 2023 DSCSA Enforcement
- Facility Design & Construction Tips For Up-Start Biotech Companies
Top 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter In 2019
In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s GMP inspection data for 2019 and addressed the critical and major deficiencies and the annexes and chapters with which they are associated. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each.
Using Production And Postmarket Data To Validate FMEA Assumptions
One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.
3 Strategies To Address The Biggest Concerns Facing Generic Drug Makers
Amid this opportunity for generic drug makers to capitalize on patent expiration, they’re facing struggles around pricing power. COVID-19 also exposed the fragility of supply chains that were built with economic efficiency rather than resiliency in mind.
An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published its GMP deficiencies data for drug product issued during inspections in 2019. This article provides a high-level overview of that data, including trends from the four most recent MHRA reports (2015, 2016, 2018, and 2019), and identifies and evaluates the critical and major deficiencies from 2019.
Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues
The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.
6 Things We Need From FDA Before Full 2023 DSCSA Enforcement
This article suggests concrete actions the FDA can take to help unify a complex and diverse group of stakeholders prior to enforcing the full requirements of the Drug Supply Chain Security Act (DSCSA) in Nov. 2023.
Facility Design & Construction Tips For Up-Start Biotech Companies
Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedule, and maintain quality.
Seeing Double: Using Digital Twins To Improve Pharma Processes
The pairing of the virtual and physical worlds not only enables systems to be adapted or repaired from afar, but the approach also further enables the analysis of data and monitoring of systems to avoid problems before they even occur.
PHARMA ONLINE WHITE PAPERS
Overcoming Encapsulation Issues Caused By Sticky Formulations
This guide provides a best-practices approach to troubleshooting capsule-filling problems when handling a sticky product formulation.
Performance Validation, Verification, Monitoring and Testing
This white paper gives guidance on the essential processes of validation, verification, and routine performance monitoring for in-line product inspection equipment in food making facilities.
Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics
Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.
Avoiding HPAPI Contamination
Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and CMOs carefully select equipment, outline processes and deploy appropriate containment strategies.
Using Parallel Evaporators To Escalate COVID-19 Test Kit Preparation
An issue for all countries now is how to obtain a sufficient supply of COVID-19 testing kits, when the international demand for them has never been higher. As laboratories around the world scale up their production of PCR test kits to aid the global fight against the virus, improvements to the workflow for producing testing kits are urgently needed to increase the efficiency of test kit production. Centrifugal evaporators offer an ideal solution to improving the efficiency of test kit production.
Understanding And Controlling Raw Material Variation In Cell Culture Media
An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
This e-book is a compilation of various statistically based techniques to help determine risk-based sample sizes to support process validation activities. It is intended to aid the practitioner avoid regulatory compliance issues. To that end, each technique provides the context for its application, formula(s), variables, and a fully worked example to help understand and apply the technique. Additionally, each technique demonstrates the linkage to risk to help demonstrate “a high degree of assurance.”More Content Collections