Featured Pharma Online Editorial

1. Top 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter In 2019 1/18/2021

   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.

2. Using Production And Postmarket Data To Validate FMEA Assumptions 1/15/2021

   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. An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report 1/11/2021

   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. 

4. Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues 1/8/2021

   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.

5. Tips For Building A Voluntary QA Culture In A 2021 COVID World 12/21/2020

   As we say goodbye to 2020, the end of which couldn’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment.

6. Implementing Improved Analytical Methods To Support Vaccine Quality 12/18/2020

   Some of the new COVID-19-targeted vaccines are spurring the use of novel analytical technologies to support rapid and thorough characterization, which may help pave the way for other vaccine manufacturers to implement these technologies as well.

7. FDA FY2020 Drug Inspection Observations And Trends 12/9/2020

   This article presents the FDA's most recent publication of GMP drug inspection data, which address drug inspections conducted in FY2020. We examine data from FY2020 and evaluate five years' worth of trends in drug GMP inspection enforcement.

8. Cleaning Process Development: Time To Clean Studies & The Cleaning Assurance Level For Pharmaceutical Products 12/4/2020

   A simple time to clean study can provide a rapid and efficient way to evaluate the behavior of a product during cleaning and obtain a reasonable estimate of the actual amount of time needed to achieve acceptable cleaning.

9. Managing CMO Quality And cGMP Compliance Capabilities: A Framework 11/25/2020

   When it comes to current good manufacturing practice (cGMP) compliance, many sponsors lose sight of their responsibility to ensure that each gram or dose of externally derived output fully meets its registered parameters and has been demonstrated by the contract manufacturing organization as manufactured in full compliance with the requirements of cGMP.

10. Advancing The State Of Aseptic Processing: Let’s Get Serious 11/23/2020

    It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination resulting in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies.