Blog

Auditing Warehouse Operations

Auditing Warehouse Operations

Frequently, a significant portion of most pharma manufacturing facilities is the warehouse operations area. Under this “pharma” umbrella we would include chemical manufacturers, API manufacturers, finished pharmaceutical manufacturers and contract manufacturing...

Software as a Service

Software as a Service

Software as a Service (SaaS) products are being utilized by Life Science companies to address solutions for some specific regulated practices and processes. One such product, from my previous experience, is a Learning Management System. The software provides the...

Maintaining a Validated GMP Automation System

Maintaining a Validated GMP Automation System

Congratulations … the new automation system has been successfully validated. Regardless of the validation methodology employed, the Project Team has invested countless hours completing the validation, employing the system into its Operational Phase of a system Life...

Conducting Due Diligence Audits

Conducting Due Diligence Audits

There is a rising tendency within the Life Sciences industry, particularly within pharmaceutical manufacturing, to partner with contract manufacturing organizations (CMOs) to provide a particular segment/niche within their product manufacture and/or project timeline....

The Drug Supply Chain Security Act Summary

The Drug Supply Chain Security Act Summary

This article, provided by Regina Fullin, Sr. Compliance/Validation Consultant from Compliance Team, Inc., provides an executive summary of the FDA Drug Supply Chain Security Act (DSCSA), passed into law to address a growing problem with counterfeit products which are...

What is the Cost of Quality?

Not everyone understands the value of quality within the organization. One of the reasons why might have to do with how we assign value, or cost, to quality. Most experts agree that non-conformances (rework, complaints, scrap, CAPA) account for 60-80% of total quality costs! What are you doing to measure, monitor, and ultimately, reduce the costs of quality within your organization?

A Horizontal Analysis of CAPA

CAPA is much more than a quality system methodology. In fact, you are probably already analyzing CAPA data from various sources as a measure of performance management. However, taking a wider view of CAPA allows you to change your perspective and focus resources on customer and process feedback in a manner that will drive meaningful innovation and business growth.

Training – Is it really a CAPA?

Re-training may be one of many actions taken as part of an investigation, but it shouldn’t be the only action. Assuming that your training program is effective in developing the necessary technical skills, communicating compliance needs and expectations, and ensuring operators are qualified and competent prior to task execution, what is the likelihood that retraining really is a good CAPA?

Taking a Risk

Risk management continues to be a hot topic for our industry, yet many organizations haven’t yet fully implemented this quality system. Some don’t even really understand the concept. What is risk management? It’s not just about analyzing the risk or even controlling it. Risk management is an integral part of the overall business management process. It includes risk review and communication of risks. There are a variety of ways to execute risk management, but you first need to understand the requirements in order to pick the right tools for success.

Do you have questions about the FDA’s Guidance for Industry, "Process Validation: General Principles and Practices?" Learn how we helped one of our clients take the first steps in meeting the requirements.

Catalyst Compliance Group