The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. The agency also introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.
Following these five rules will ensure that OOE investigations are conducted in a scientific and meaningful manner, with each instance providing a genuine opportunity for improvement.
Learn what U.K. Medicines and Healthcare products Regulatory Agency (MHRA) Senior GMDP (good manufacturing and distribution practices) Inspector Tracy Moore had to say about MHRA’s efforts in the areas of drug/device supply chain security and international efforts on harmonization of data integrity guidance.
The commissioning of a facility, equipment, or system for operation under GMP regulations involves qualification that all operations are suitable for the intended purpose. The facility owner must have traceable verification of the systems, minimizing punchlist items to improve start-up and eliminate problems up front.
When creating and managing electronic documents, document metadata deserves as much attention as document content. Firms that do so can improve compliance and even gain potential competitive advantage by realizing electronic documents (with appropriate metadata) as real business assets.
The Medicines and Healthcare Products Regulatory Agency (MHRA) published a revision to its 2015 Data Integrity Guidance, finalizing the draft revision published for consultation in 2016. The revision was a coordinated effort among the GCP, GDP, GLP, GMP, and GPvP inspection groups, reflecting a broad source of input.
Typically, supplier management programs use a supplier survey or an on-site audit to verify if a supplier is compliant with the requirements of a standard or regulation. However, for a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation. A value-added supplier management program should also consider items such as supplier capability, capacity, and contingency planning.
Over the last several months, we’ve heard of far too many incidents of sexual harassment or worse coming to light. In the event you’re not familiar with the terms, #MeToo is a hashtag used in social media to demonstrate the prevalence of sexual assault and harassment. It went viral as victims started to post their own stories, showing how widespread the problem actually is. Founded by Hollywood celebrities in response to several high-profile sexual harassment and assault cases in the entertainment industry, the Time’s Up initiative champions change in these behaviors and works to establish fair treatment for all.
This article presents a detailed summary of the drug GMP warning letters issued in FY2017, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements.
Because a training program is a compliance requirement for GMP operations, similar to the compliance requirement to have a QA organization, it is typically considered part of the cost of quality for regulated operations. But, the requirement to have a training program is more than a means to assure compliance; it is an opportunity for companies to increase profits and reduce costs. These avoidable costs are referred to as the cost of poor quality (CoPQ).