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. 
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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


Compounding Labeling

On Sept 27, 2018 FDA shared recent case reports of dosing errors and confusion with the labeled strength expression for certain compounded unjectable products.  Both MedWatch reports attributed the medication error to the labeling of the drug (IV/Syringe) packaging. See Differences in strength expression on product lables of compounders and contentional manufacturers may lead to dosing errors.… more


Promoting a Validation Mindset: Overview

Among our cadre of validation engineers and specialists we offer an experienced and knowledgeable team of personnel whose area of expertise is focused on the delivery of validation services for computerized systems. With decades of combined experience in the computerized systems validation field, our team has gained an informed point of view of what constitutes a successful validation project and the organizational practices the make it successful.… more


Summary of the 2018 Q3 FDA Observations

FDA has posted 17 Form 483s, to 503B facilities, thus far in the third quarter of 2018.  FDA has identified 68 observations of potentially objectionable issues within these 17 facilities.  A summary of the 2018 Q3 FDA Observations follows:

Table 1 – 68 observations categorized by topic

Category of Observation Frequency of occurance
Disinfection 14
Aseptic Technique 11
Containment 7
Poor Facility Design 7
Enviornmental Monitoring 5
Maintenance 4
Critical Air Flow 3
Production Processes 3
Media Fills 3
Cleaning 2
Equipment 2
Finished product testing 2
Improper Materials 2
Adverse Event Reporting 1
Lab Methods 1
Quality Review 1

As we can see from the above table, the two largest groupings of observations fall into the disinfection and aseptic techique. … more


ISO 9001:2015

Performance Validation’s quality management system is based on ISO 9001:2008, Quality management system – Requirements.  As you are aware, ISO 9001:2008 was revised to ISO 9001:2015.  A three year period was provided to allow companies to review and revise their quality systems to the new standard. … more


503B cGMP Inspection

Are you really ready for your initial or follow up 503B cGMP Inspection?

Most 503B outsourcing facilities would assume they are ready for inspection, but often this is not the case.  Thus far in 2018 – FDA has issued 62 Form 483’s to 503B Outsourcing Facilities at the conclusion of the 503B cGMP inspection.… more