Resources

The Real Story Behind Outsourcing Facilities: Are They Still Worth It and Were They Ever? PART I History and Background: The New England Compounding Center (NECC) preparation and shipment of contaminated injectable products across state lines in 2012 created a firestorm of publicity and enforcement actions. More than 750 patients in twenty states developed a fungal […]

We took a snapshot of the 10 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from products not meeting “the definition and standard for chocolate” to sites “refusing to permit the FDA inspection” altogether. From pharmaceuticals in Italy, Pennsylvania, and more, here they are (starting with the most recent): Berkeley […]

How to Prepare for a GMP Inspection for Small and Virtual Companies Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when resources are limited and staff may have little expertise in these important activities. This becomes especially complex for start-up companies that are virtual, or essentially virtual, and rely on contract manufacturers […]

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to put expiration dates on containers to failing to put soap in the bathrooms. From pharmaceuticals in Canada, Spain, and more, here they are (starting with the most recent): Horizon Pharmaceuticals, Inc., […]

FSMA is Here. How Do You Manage 1,000 Food Suppliers? The advent of the FSMA in the US means that everyone in your supplier network can expect an inspector to knock at some point, underlining the imperative for supplier accountability to compliance teams. Brand revenue and reputation ride on the outcome. This means effectively keeping […]

  Changes in Regulatory and GMP Intelligence Surveillance, analysis and communication of regulatory and GMP intelligence has evolved over the past decade. The individual(s) tasked with this activity within pharma companies require broad experience in regulatory affairs and GMP compliance. The individual(s) must have sufficient historical perspective to compare and contrast new requirements with those they […]

An Alternative to GMP Quality System Auditing in the Pharma Industry Executive Summary: Historically, a quality systems approach to GMP auditing has become common practice. However, this systems approach does not routinely address the essential input into the system – the data.Data integrity issues have drastically increased in the last year – and not just […]

We see a lot of people, all throughout the world, purchasing 483s from our FDA 483s store. For example, this month, customers from theUnited States, India, South Korea, China, and the United Kingdom purchased 483s. As a reminder, here are 5 features to look for in a 483. Here are the latest 30 483s purchased […]

We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from failing to maintain complete data to failing to prevent microbiological contamination. From pharmaceuticals in Japan, New Jersey, and more, here they are (starting with the most recent): Wockhardt Limited, Mumbai, India – 2 violations:Failed to […]

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from allowing unauthorized access to confidential data to forgetting to put expiration dates on drugs. From 3 pharmaceuticals in the USA and 3 abroad, here they are (starting with the most recent): Beijing Taiyang […]