Greenfield Capital Expansion Project

Challenge

A large mid-western pharmaceutical company embarked on a large capital project to increase their global production of several drugs. This expansion project required the construction of three (3) new buildings, as well as various utility and manufacturing equipment additions. The scope of Performance Validation’s commissioning and validation work including the following systems:

  • Compressed Air Generation and Distribution
  • Nitrogen Distribution
  • Process Alcohol Distribution
  • Plant Steam Generation
  • Pure Steam Generation and Distribution
  • Vapor Compression Distillation Pretreatment Unit
  • Two (2) Vapor Compression Distillation Units
  • Cold Water for Injection Distribution
  • Hot Water for Injection Distribution
  • Purified Water Distribution
  • Drive-in Refrigerator
  • Three (3) Walk-in Refrigerators
  • One (1) Walk-in Freezer
  • One (1) Drive-in Freezer
  • Two (2) Reach-in Freezers
  • Ten (10) Air Handling Units
  • Three (3) Facility Management Systems

Solution

Performance Validation (PV) developed and executed the applicable commissioning, installation, operational, and performance qualification deliverables to ensure that all the systems included in our scope were installed and functioned as required by the client and per vendor recommendations.… 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


PEW Report – State Oversight of Drug Compounding

As reported by the Pew Charitable Trust, Feb 26. 2018:

  • The Pew Charitable Trusts’ drug safety project has identified more than 50 reported compounding errors or potential errors from 2001 to 2017 linked to 1,227 adverse events—undesirable experiences associated with the use of a medical product—including 99 deaths [bold added by author].
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


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


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


Josh Ciesiolka – PV’s Technical Expert on Lyophilization

Josh Ciesiolka is a Senior Validation Engineer and certified project leader at Performance Validation.  Josh has led a number of complex Lyophilization projects including retrofit of existing units, installation of new units and integration with automated loading and unloading systems.  He is PV’s technical expert in regards to the commissioning, qualification, and validation of Lyophilization equipment and processes. … more


FLU

Normal flu vaccines are prepared each year and target a specific flu strain.  If however the flu strain mutates or is not the strain anticipated than often the vaccine provides limited protection.  It takes many months to develop the doses needed to protect the general population.… more