Compliance Insight, Inc Successfully Assists Clients with Facilities and Regulations

March 25, 2013 - PRLog -- (Fairfield, Ohio) – Compliance Insight Inc., a regulatory and quality assurance consulting firm, profiles a proven track record in successfully helping clients with manufacturing facilities regulations and consent decrees.

European Manufacturing Facility

A US firm acquired a manufacturing facility in Europe.  All systems at the facility had to be evaluated and variances from current GMPs remediated.  The project spanned 2.5 years during which time the following occurred:

·      Audit and remediation of USP Purified Water system anomalies

·      Training system completely remodeled

·      Investigation system completely remodeled

·      Validation program implemented

·      HVAC controls implemented

·      Facility design and flow of material modified to function

·      Warehouse system modernized for GMP compliance

·      HOsted successful FDA audit and responded to initial list of 483 observations effectively to gain approval for manufacture and distribution within the US.

Pharmaceutical Company with Consent Decree

A large Midwestern solid, oral dosage form company contacted Compliance Insight for help in compliance with a US FDA consent decree.  Compliance Insight’s involvement included the following:

·      On site QA Plant Manager for two years

·      Complete quality, operation, utility, facility and warehouse systems overhaul - all procedures and documentation

·      Direct contact with FDA during audits

·      Provided options and viable paths to be compliant

·      Did not overwhelm firm with auditors/consultants

·      Timely and met all required dates for compliance activities

·      Served 1 year as OPS QA Oversight to assist with continual improvement process

·      Implemented new investigation process and CAPA program

·      Served as interim Quality Director

·      CI provided Quality Oversight for first product to be a pproved for manufacture and shipment post Consent Decree. CI completed project with systems functioning within acceptable parameters.

Compliance Insight, Inc. specializes in Regulatory and Quality Assurance consulting and training for pharmaceutical, nutraceutical, medical device, chemical, and bio-technology companies in North America, Europe and Asia.

For more information visit http://compliance-insight1.com/