April 2017

27
Apr

GMP Inspection Deficiency Data Trends for 2016 – Who is Minding the Store?

With the recent publication of the GMP Inspection trends for 2016 from the MHRA (here) and the FDA (here), companies involved with the observations might want to reconsider their internal audit processes. If you evaluate the examples of the issues observed, you would question why internal audit programs do not catch many of the issues […]

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25
Apr

Can You Believe This?  Unfortunately, It Seems to Be the Norm!

The FDA announced today that it issued Warning Letters to 14 companies for selling unapproved cancer treatments ranging from thermal devices to creams, ointments, syrups, teas, and various pills.  Life is too short to have charlatans trying to steal precious chances for life from cancer patients.  While I am glad that the FDA has acted, […]

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24
Apr

MHRA GMP Inspection Deficiency Data Trend 2016

The MHRA has presented their 2016 inspectorate deficiency trend data for 2016. MHRA publishes the assessment with the hope that industry will perform their own assessment against the deficiency findings, as part of self-inspection and continuous improvement. A complete version of the MHRA presentation  can be found here. In comparison to 2015, the MHRA increased […]

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17
Apr

Data Integrity: A View from Down Under

Following the lead of many of the world’s pharmaceutical regulatory agencies, on April 6, 2017, the Australian Therapeutic Goods Administration (TGA) released a Data Management and Data Integrity (DMDI) policy statement. TGA states that the policy “serves to provide some clarification regarding the TGA’s official position regarding DMDI practices for industry,” but at the same […]

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14
Apr
Is Your Instrumentation Qualified for Intended Use Image

ICH M10 – Bioanalytical Method Validation – Is Harmony Coming to a Lab Near You Soon?

The 11th annual Workshop on Recent Issues in Bioanalysis (WRIB) has ended in sunny Hollywood, CA.  The WRIB provides an opportunity for both industry and regulators to discuss challenges facing the bioanalytical community in the analysis of both small and large molecules.  This year’s workshop had the largest turnout ever, with approximately 750 attendees from […]

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10
Apr

Jean Poulos, M.S, M.B.A., new Principal Consultant at Lachman Consultant Services, Inc.

We are pleased to announce that Jean Poulos has accepted the position of Principal Consultant in the Regulatory Practice at Lachman Consultants, effective April 10, 2017. Ms. Poulos is a seasoned Regulatory professional with more than 25 years of combined quality assurance, quality control, regulatory affairs and compliance enforcement experience in the pharmaceutical / biotechnology […]

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