OIG Signals Importance of Board-Level Compliance Committee in J&J Corporate Integrity Agreement
In the just issued Johnson & Johnson Corporate Integrity Agreement (CIA), the Office of Inspector General (OIG) has, for the second time in less than a year, required that a company maintain a...
Government Aims its Sights on Smaller Pharmaceutical Companies
Big pharma and their deep pockets have been the focus of enforcement activities for a number of years but in 2013 that tide may be turning. In the past few months, settlements with ISTA...
Do Not Neglect GMP in your Serialization Project
In what for some may be a relatively chaotic run-up to meeting California’s 2015 serialization regulation, it is critical for serialization project managers to assure implementation falls within the...
Three Solutions to Typical Autoclave Temperature Mapping Conundrums
Temperature Mapping is an intrinsic part of equipment validation. It evaluates the quality and compliant nature of the equipment to ensure the equipment meets the user and regulatory agency’s...
Risk-Based Computer System Validation and Rational Testing
Introduction Risk based approaches to validation of computerized systems have been heavily promoted since the publication of GAMP 5 and ASTM E2500. Yet we continue to see examples of validation...
Life Cycle Considerations for High Quality and Regulatory Compliant Software
By way of introduction I have developed, implemented, and validated computer/information systems for longer than I care to admit … they were still using punch cards to program room-sized computers...
ISO13485: Understanding the Management Review Metrics Scorecard
As discussed in part one and part two of this series, ISO13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the...
Wondering Why You Should Evaluate the Effectiveness of Your Corporate Compliance Program?
On May 24, 2013, the Department of Justice announced that ISTA Pharmaceuticals Inc., a subsidiary of Bausch+Lomb, pled guilty to felony charges of conspiracy to introduce a misbranded drug into...
Visual Inspection for Cleanliness, What Are We Missing?
As a way to verify that your cleaning or cleaning-in-place (CIP) process was successful, what tool, assay or method should you use first? Well, shouldn’t the answer be as plain as the eyes on your...
ISO13485: Do You Know What Types of Data Should Be Evaluated at Management Review Meetings?
ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the Quality Management System (QMS). Section 5...
ISO13485: The Importance of Management Review
ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the Quality Management System (QMS). Section 5...
Calibration and Verification: Are you using these terms correctly?
No matter where I go I am always amazed at how many times the words calibration and verification are misused. I often hear statements like, “The instrument doesn’t need to be calibrated, the accuracy...
Discover New Issues Concerning Critical Process Cleaning
“Cleaning, how hard can that be,” is the sentiment of those not in the bio/pharmaceutical industry. Even for those within the industry, the general consensus regarding Cleaning and Cleaning...
Are Your SOPs "Reference-Crazy"?
While Standard Operating Procedures (SOP’s) are widely and rightly used to control processes, there is sometimes a tendency within organizations to go “reference crazy”. In a well-meaning attempt to...
What is Blood Plasma?
Blood Plasma, or simply plasma, is the liquid portion of blood. It has a number of vital functions in bleeding and infection control. It contains proteins and antibodies, which are produced by the...
Which Comes First, People or Systems? - Building & Maintaining Regulatory Compliance
Regulations require the pharmaceutical industry to be compliant, have and maintain a quality system, and build quality into the process (quality by design). What does that truly mean and how does the...