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


Promoting a Validation Mindset: System Owners

The system owner is the individual responsible for the availability, security, compliance, maintenance, and support of a computerised system and for the security of the data residing on that system.  The system owner is initially responsible for oversight of the computer system validation effort, and is ultimately responsible for maintaining the system in a validated state throughout the life of the system.more


ISPE Vision to Reality: Delivering Next Generation Therapies

This year’s theme for the ISPE 2018 Annual Meeting and EXPO is Vision to Reality: Delivering Next Generation Therapies.

One of the frequent challenges when delivering next generation therapies is available manufacturing space.  Either the existing facility is committed to current products with no excess capacity, or the time/cost to reconfigure the existing facility to meet the manufacturing conditions required by the new therapy doesn’t fit within the project budget/timeline.… more


Promoting a Validation Mindset: Subject Matter Experts

Subject matter experts (SMEs) are considered to be those individual stakeholders in a computer system who contribute their technical expertise to the system validation effort.  Among the SMEs are system software developers, infrastructure support providers, process engineers, process owners and others who share in the responsibility for design and configuration of the system.more