Blog

Assisting Indian Pharmaceutical Firms with Regulatory GMP Inspections

July 25, 2018
by SeerPharma

Pharmaceutical firms in India have turned to SeerPharma for assistance on matters of Quality Assurance and GMP compliance.

A major firm based in the state of Gujarat engaged SeerPharma to review plans of their Facility to the
PIC/S Code of GMP. The review identified gaps that will need to be addressed prior to a PIC/S GMP
Inspection. The feedback and advice provided by SeerPharma will help the client prepare for an
eventual PIC/S GMP License.

Another major Indian pharmaceutical company requested assistance from SeerPharma to respond to
findings from a regulatory GMP inspection. SeerPharma reviewed the inspection report and assisted
the client with submitting a comprehensive response. The structured response focused on High
Risk/Critical findings and provided a suitable explanation for the root cause of the issues observed.

magnifying-glass-over-paper

SeerPharma designed an approach, addressing the findings by first understanding the specific issues
the deficiencies observed. Then grouping the deficiencies to allow the determination of common root
causes. Followed by determining an effective way of addressing the deficiencies. SeerPharma was able to advise the company on common ways in which other manufacturers address similar issues.

SeerPharma also helped the company understand the potential regulatory actions and implications
that could stem from the critical deficiencies observed. Advising the company of the best channels of
communication to approach the regulatory agency with issues arising from the inspection findings.

Contact us should you need assistance with preparing OR responding to GMP regulatory inspections of your operations from member PIC/S countries and the US FDA.

This post comes from our July 2018 Journal.  You may also be interested in:

Filed Under: GMP inspections, PIC/S, FDA