FDA Issues Warning Letter to Tianjin Zhongan Pharmaceutical - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Issues Warning Letter to Tianjin Zhongan Pharmaceutical

PTSM: Pharmaceutical Technology Sourcing and Management
Volume 10, Issue 7

FDA issued a warning letter to Tianjin Zhongan Pharmaceutical on June 10, 2014 for cGMP violations for APIs that FDA identified in an inspection of the Tianjin, China plant from Sept. 23 to Sept. 27, 2013. Deviations cited included failure to adequately complete and follow written procedures for cleaning equipment and to maintain adequate records of major equipment usage, failure to conduct adequate change control, and failure to adequately review and investigate product deviations.

An inspection found that employees did not adequately clean equipment after use. FDA also noted that the firm "did not maintain equipment logs or other documents that adequately record manufacturing operations performed on individual pieces of equipment." 

Although employees had been trained in change control procedures, FDA found that they failed to comply with procedures and that the company's response did not give enough detail on how compliance would be ensured.

Inspectors found that the company failed to adequately investigate deviations and did not adequately control certificates of analysis. FDA also cited concerns about inadequate qualification of critical production equipment.

FDA concluded, "Your inability to detect and prevent the above deficient practices, as well as other deficiencies found during the inspection, indicate that your current quality system is ineffective at achieving overall compliance with cGMP." The agency recommended that the firm engage a third-party consultant with appropriate cGMP expertise.

Source: FDA

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
29%
Oversee medical treatment of patients in the US.
11%
Provide treatment for patients globally.
7%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
Source: PTSM: Pharmaceutical Technology Sourcing and Management,
Click here