US and EU Sign Agreement to Mutually Recognize Drug Manufacturing Inspections

In 1998, the European Union (EU) and the US signed the Mutual Recognition Agreement (MRA) with provisions specifically about current Good Manufacturing Practices (cGMPs) for drugs but were unable to start implementation. Since 2014, both the US and European Medicines Agency (EMA) revived agreement talks concerning the cGMP provisions. Starting in 2012 with the passage[…]

UK Pharma Industry Bracing for Possible Disruption

From FierceBiotech: GlaxoSmithKline CEO Andrew Witty fears that if the European Medicines Agency (EMA) is moved from London, it will cause a tremendous disruption for the UK’s pharma and biotech industry. Experts worry about the possibility of regulatory upheaval if Brexit happens. The fate of the EMA is in the air. Brexit is currently in[…]

Louisiana Drug and Supplement Maker Ordered to Stop Production by Courts

Judge Robert G. James of the District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a producer and distributor of several products including drugs and dietary supplements. The owner, Anton S. Botha, was ordered to cease all business operations until he complies with[…]

InstantGMP, Inc. and CfPA Present: Electronic Batch Records: Benefits and Implementation Planning Online Training Course

InstantGMP, Inc. and the Center for Professional Advancement (CfPA) have collaborated on a course entitled, “Electronic Batch Records: Benefits and Implementation Planning” InstantGMP, Inc. and CfPA have designed this course with cGMP manufacturing professionals looking to improve or enhance their process, traceability and FDA compliance with electronic batch records in mind. This course invites professionals[…]

Will Brexit and Trump Affect Future Pharmaceutical Packaging and Labeling Regulations?

The Pharmaceutical industry is gradually coming into compliance with new regulatory requirements including the Falsified Medicines Directive (FMD) for Britain and the Drug Supply Chain Security Act (DSCSA) for the US. An important deadline coming up in November 2017 mandates that manufacturers must include product identifiers, serial numbers, lot numbers, and expiration dates in their[…]

The Importance of Quality Agreements

While using third-party contract manufacturers has become a common trend in the pharmaceutical and biotech industry, it is not without risk. The practice supposedly keeps costs down by avoiding equipment, validation, personnel and other production expenses leaving the burden of following Good Manufacturing Practices (GMPs) on the contract manufacturer, but this may not always be[…]

Trump Declares War on Drug Pricing – Or Did He?

This story is continually developing. If Trump his policies once more, we’ll post an update highlighting the new details. In January, President Donald Trump loudly declared that pharmaceutical companies are “getting away with murder” with what they charge the government and patients for medications. Unsurprisingly, his statement drove numerous drug stocks down and effectively put[…]

3.002.002 Release Notes

3.002.002 is a minor update to the software and includes fixes to the old receipt number error in 3.002.001 and a production number error from 2.048.001. We’re developing some great new features and functionalities for 2017, so stay tuned! Fixes • Display Error – On Version 3.002.001 we introduced new Inventory functionalities, but when you[…]