Compliance Insight, Inc Successfully Assists Clients with Validation, Regulations and Contamination

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 validation and regulations, and contamination defense.

New API Facility in China

Compliance Insight was hired to establish quality systems, file all regulatory submissions and manage validation activities to establish a new API facility belonging to a Chinese/American joint venture group.  The facility was constructed in a small city in China.  The project spanned 1.5 years during which time the following occurred:

·      Facility utilities, manufacturing equipment, and the API process were successfully qualified/validated.

·      All Quality Systems were established

·      Provided GMP training for multiple subjects including ICH Q7A, Validation, GDP, API process, and more

·      Drug Master File was filed

Compliance Insight was able to work with language, cultural, and regulatory differences to the complete satisfaction of all involved. The Prior Approval Supplement for use of the API manufactured at the facility was approved by FDA. SFDA invited Compliance Insight to hold ICH Q7A training for industries interested in marketing to the U.S.

Law Suit

Compliance Insight was engaged by a law firm which was, at the time, retained by a company being sued by a high profile athlete.

·      Compliance Insight was retained to perform a gap assessments of 26 contract manufacturers and contract laboratories utilitized by a company.

·      Compliance Insight was requested to investigate potential contamination of a dietary supplement ingested by the athlete.

All 26 facilities were evaluated and findings shared with the law firm. A suspect source of contamination was identified.

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/