Featured Pharma Online Editorial

1. 5 Steps To Eliminate Weak Links In Your Data Governance 12/2/2022

   Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.

2. FDA Releases Guidance On Drug Products Containing Nanomaterials 11/18/2022

   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.

3. Key Insights From The 2022 PDA/FDA Joint Regulatory Conference 11/3/2022

   Key focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.

4. Pharma Process Validation: Initial Conclusions Are Often Deceptive 9/26/2022

   As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.

5. A Practical Guide To Navigate The EU's Revised GMP Annex 1 9/9/2022

   The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.

6. How To Avoid Form 483s For Biopharma Software Validation Failures 8/17/2022

   The FDA will issue a Form 483 for noncompliance in the software validation GxP environment, mostly due to data integrity failures, inadequate written procedures, deficiencies in investigations, and substandard laboratory controls.

7. Tools & Techniques For Biopharma Root Cause Analysis 8/10/2022

   In biopharma, we must provide a complete and thorough record of our thought processes in order to allow a third party to understand how we have arrived at the root cause of a given problem. This article follows a mock case study to demonstrate a progression of tools and techniques to use.

8. CAPA System Best Practices For GMP Compliance 7/25/2022

   A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. This article delves into the pros and cons of autonomous and integrated systems, and shares some overall CAPA best practices. 

9. FDA Seeks Comment On ICH Q9(R1) Quality Risk Management 7/5/2022

   ICH has revised Q9 Quality Risk Management, providing principles and tools that can be applied throughout the product life cycle of drug substances, drug products, biological, and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry. 

10. FDA Updates Guidance For Investigating OOS Test Results 6/24/2022

    FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.