ARTICLES BY MARK DURIVAGE

• FDA Seeks Comment On Circumstances For Delaying, Denying, Limiting, Or Refusing An Inspection

  1/9/2023

  The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.

• FDA Seeks Comment On Conducting Remote Regulatory Assessments

  8/11/2022

  The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.

• 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. 

• FDA Updates Guidance For Investigating OOS Test Results for Pharma Production

  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.

• FDA Publishes Guidance For Biopharma Container Labels & Carton Labeling Design

  6/13/2022

  The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.

• FDA Issues Guidance On Initiation Of Voluntary Recalls

  4/5/2022

  This guidance supports the requirements of 21 CFR Part 7 Enforcement Policy for drugs, medical devices, and biological products, and is being issued consistent with FDA's good guidance practices regulation. You may submit comments regarding this guidance to the agency at any time. 

• FDA Seeks Public Comment On Quality Metrics Reporting Program

  3/17/2022

  The FDA recently announced it is soliciting comments on changes to its previously proposed Quality Metrics Reporting Program. This article shares which primary metrics the FDA intends to collect data on as well as the FDA's questions for input. The comment period ends June 7, 2022.

• FDA Proposes Inspection Of Injectable Products For Visible Particulates

  2/1/2022

  FDA and CDER have released a draft guidance addressing the development and implementation of a holistic, risk-based approach to visible particulate control incorporating product development, manufacturing controls, visual inspection, particulate identification, investigation, and corrective actions. The public comment period ends Feb. 15, 2022.

• FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities

  5/3/2021

  On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.

• Integrating Risk Management In The Quality Management System — A Primer

  4/7/2017

  This article will first present the definitions and requirements regarding risk and then introduce some tools that can be utilized to incorporate and integrate risk management techniques in and throughout the QMS.

• How To Establish Sample Sizes For Process Validation Using LTPD Sampling

  12/27/2016

  The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of lot tolerance percent defective (LTPD) to establish sample sizes for process validation.

• How To Establish Sample Sizes For Process Validation Using Variable Sampling Plans

  11/28/2016

  The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of variable sampling plans to establish sample sizes for process validation.

• How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem

  7/19/2016

  This article demonstrates two methods using the success-run theorem, which uses the confidence level (how sure we are) and reliability value (valid, consistent results) to determine appropriate statistically valid sample sizes for process validation.

• Risk-Based Approaches To Establishing Sample Sizes For Process Validation

  6/14/2016

  Using confidence, reliability, and acceptance quality limits (AQLs) to determine sample sizes for process validation are proven methods to ensure validation activities will yield valid results based upon an organization’s risk acceptance determination threshold, industry practice, guidance documents, and regulatory requirements.