FDA Funding

On March 11 FDA Commissioner Scott Gottlieb provided a statement in the request for new FDA Funding. The full FDA statement is available here. Below is the excerpt concerning funding requested to Strengthen the FDA’s oversight of compounded drugs to help secure patient safety:

The practice of compounding medicine can provide important public health opportunities.… more


21 CFR 211.42 – Buildings and Facilities

A review of FDA citations for 21 CFR 211.42 Subpart C Buildings and Facilities over the past 5 years (2018-2014) from the FDA Turbo data was conducted by Performance Validation. Our analysis identified that the highest frequency of citations within the buildings and facilities subpart were consistently attributed to two code sections:

  • 21 CFR 211.42(c)(iv) A system for monitoring environmental conditions;
  • 21 CFR 211.42(c)(v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions;

The citations to these two sections are illustated below for the past 5-years.… more


Consensus Standards

The Center for Drug Evaluation and Research (CDER) releases the CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Guidance for Industry draft guidance for comment.

This proposed guidance will address how CDER will informally recognize volunatry consensus standards.… more


New CRF4 Fogger

Performance Validation’s Critical Airflow Visualization Services Group has purchased an Applied Physics CRF4 cleanroom fogger. As noted in the above video [downloaded from Applied Physics USA], the CRF4 is a portable cleanroom fogger that can use deionized (DI) water or water for injection (WFI water) to generate 1.25 cubic meters of pure fog per minute at 170 ml fog density per minute to provide from 10 to 15 feet visible fog distance.… more


Process Validation

In a recentlyposted warning letter to a Chinese drug manufacturer the FDA identified a specific violation citing the Jan 2011 FDA Guidance to process validation.

Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).more


Comparison of FDA cGMP Compounding Guidance

Comparison of FDA cGMP Compounding Guidance.

Background:

The initial Guidance for Industry cGMP – Interim guidance was issued July 2014 and a link to this document is available here.  A total of 25 comments were received from various organizations which are available for viewing here. … more


Facility Design

One of the key elements supporting commercial manufacturing of pharmaceutical or compounded products is the facility design.  This element is captured in the Drug cGMPs as subpart C Buildings and Facilities, and codified in 21 CFR 211.42 Design and construction features.… more


Data Integrity Final Guidance

FDA has issued the Data Integrity and Compliance with Drug cGMP final guidance on December 13, 2018.  The final guidance is available at the following link.

As stated in the Introduction section of the guidance:

FDA expects that all data be reliable and accurate (see the “Background” section).… more


Data Integrity Remediation

In a recently posted warning letter, the FDA identified significant data integrity issues associated with electronic data logs for production equipment and laboratory records.

This citation was based on:

  • The firms electronic data logs not retaining alarm messages indicating when certain manufacturing parameters exceed their limits during production operations. 
more

FDA Regulation and Inspection Guide

Are you a 503B trying to understand the FDA Regulation and Inspection Guide?  Do you feel like these guys?

I have a limited number of FDA Guidebooks that contain the FDA regulations 21 CFR parts 210 and 211 cGMPs in Manufacturing, Processing, Packing, or holding of drugs and finished pharmaceuticals AND the Drug Manufacturing Inspections: Compliance Manual for FDA Staff (7356.002) Drug inspections.… more