UKMHRA warning to MARKSANS PHARMA , findings and their response regarding this warning .

1. Welcome to the Presentation
Topic : UK MHRA on MARKSANS Pharma
Presented to
Dr. Shamsun Nahar Khan
Associate Professor
Department of Pharmacy
East West University.
Presented by
Tahiya Tabassum,
2015-1-70-008

2. First inspection : March 2015 at Goa plant
Identification:
 Major deficiencies in the operation of the Pharmaceutical
Quality System. These included Systems to ensure –
Data integrity, Deviations and CAPA management, Change
Controls, PQRs and Self-Inspection.

3. Second inspection:
23’rd-25th November 2015
at Goa plant
Issue: “Restricted GMP
Certificate” with a copy of
the “statement of non
compliance with GMP”
Identifications
 Evidence of destruction of multiple parts of records of
prime data
 Overall Data Integrity management and oversight
 Investigations into Missing and deleted data within the
laboratory incomplete
 Procedures controlling Data Integrity within the
laboratory not in place
 Withdrawal of previous GMP Certificate No

5. • .
Marksans Response :
Marksans Pharma announced that it
received a restricted good manufacturing
practices (GMP) certificate from the UK
Medicines and Healthcare Products
Regulatory Agency (MHRA) for its
Indian facility in Goa following
violations of manufacturing norms.
The company noted that
it will remain able to
manufacture and market
products from the site.
"The restricted GMP status would continue
until MHRA's next inspection , next
reinspection can be as early as when the
qualified person EU certifies site to be
inspection ready. Once re inspected, the same
can be reinstated to GMP compliant status."
"Marksans Pharma is committed
to complete holistic remediation
and be inspection ready to be
GMP compliant at the earliest,"
the drugs maker said.

6. Observation of Leaflet