Supplement Maker Warned by FDA for Misbranding and Procedural Violations

Per FDA News, Sanapac, a dietary supplement manufacturer, was notified by the Food and Drug Administration for GMP violations, adulterated products, and misbranding products after an inspection in 2016. After an inspection in November, FDA inspectors returned the following month and found numerous issues in regards to the lack of written Standard Operating Procedures for[…]

InstantGMP MES v2.052 Released

Cary, NC – InstantGMP, Inc. announces the release of InstantGMP MES v2.052 with amazing new features InstantGMP, Inc. added many great new functions and updates to their electronic batch records software to enhance their user’s experience. “We are excited about the new master production record and batch production record features in our v2.052 release” said[…]

InstantGMP MES v2.052.000

Let’s take a look at what’s new in the newest release, InstantGMP MES v2.052.000! New Functionalities Expanded badge signature capabilities to system-wide usage. Added new workflows focused on Project Management functionalities allowing for projects to include multiple products for multiple clients with multiple user access control under multiple roles. Added new Material Classifications to help employ[…]

New FDA E-Cigarette Regulations Coming

E-cigarettes will soon be regulated under tobacco products as a rule proposed by the Food & Drug Administration (FDA). The rule is currently being reviewed by the White House Office of Management and Budget’s Office of Information and Regulatory Affairs. It will be several weeks before the proposed rule is formally approved and any action[…]

Booming Natural Supplements Business in China

From Natural Products Insider, health food sales in China are estimated to reach RMB300 billion ($47.5 billion USD) by 2019. More and more Chinese consumers are looking to natural supplements as rates for certain illnesses such as lung cancer and breast cancer are on the rise, and they are looking to purchase foreign health products. It[…]

DNA Barcode Testing: Does it Work for Dietary Supplements?

In February of this year, the New York State Attorney General’s Office investigated major retailers for selling dubious and potentially dangerous herbal supplements according to the New York Times. They targeted Walgreens, Target, Walmart, and GNC, all well-known big box retailers that generally sell safe products. The authorities said that they had tested the herbal[…]

Material Specifications required in Master Manufacturing Records

Recently, a question was posed in a LinkedIn group regarding revising Master Manufacturing Records and whether specifications need to be included in the record. When revising MMRs or MPRs, you should first consult your SOPs for document control, MMRs and specifications. Specifications should be separate documents including the tests, methods, limits and frequency of testing[…]