Only 59% of Pharma Companies...

Own Dedicated Compliance Departments, According to Research by Cutting Edge Information

Can this possibily be correct???...

A stand-alone Quality function is a direct requirement of federal law governing GMP activities...21CFR etc etc etc

I'll have to download the report and read it...that's funny...it's so questionable, I'll take the time to read it...

A new study by business intelligence firm Cutting Edge Information finds that only 59% of pharmaceutical companies currently own dedicated departments for compliance. The study, "Monitoring and Ensuring Pharmaceutical Compliance," highlights the growing need for creating a dedicated compliance department.

With only 59% of pharma maintaining a dedicated department for compliance, there are still a healthy percentage of companies who remain vulnerable to unforeseen regulatory changes. Building a strong compliance management team will give the staff the necessary power to effectively manage their internal clients' changing needs.

Maintaining a dedicated compliance department also signals to outside agencies that the company takes regulation seriously. Giving an outward appearance of a company willing to police itself goes a long way in the court of public opinion. The damage done by a compliance misstep can take a long time to recover from -- both legally and in the eyes of company stakeholders.

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link to report download

New GMP Regs

The FDA has responded to industry comments with some new rules...

FDA publishes final rule on cGMP amendments

Regulators cite 'lack of knowledge and understanding'

A suggestion for a new SOP...

all process equipment should be cleaned at least every 5 years, or so...

The tank, in fact, was not cleaned at all between 2001 and the end of the company's April 2006 production run.

Following non-routine maintenance, the holding tank was then cleaned using ethanol according to SOP guidelines. Crucially, however, the tank was not dried afterwards to rid it of any residual ethanol.

The tank therefore still contained the alcohol when it was charged with the starting material, MSA. This resulted in a reaction that caused high levels of EMS in the Viracept starting material.

The official report into good manufacturing practice (GMP) failures that caused dangerous contamination and a Europe-wide recall of Roche's HIV drug Viracept (nelfinavir) claims the firm simply did not understand its own manufacturing processes.

The Committee for Medicinal Products for Human Use (CHMP) published its assessment yesterday, recounting the inspections and discussions that took place in the wake of the June recall and noting the "critical GMP deficiencies" that resulted in the suspension of Roche's Viracept marketing authorisation.

The European Medicines Agency (EMEA) carried out an inspection of Roche's active ingredient manufacturing facility in Basel in collaboration with Swiss regulators Swissmedic, to assess conditions at the plant where the contamination occurred.

Their examination revealed violations that not only led to the high-level contamination reported over the summer, but also led to questions regarding regular manufacturing processes and concerns over "the quality of Viracept and its safety under normal conditions of use."

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