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Maha FDA cancels WHO GMP certificates of 2 pharma cos for GMP violations
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Shardul Nautiyal, Mumbai
December 09 , 2016
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Against the backdrop of cases of non-compliance to good manufacturing
practices (GMP), Maharashtra Food and Drug Administration (FDA) has
canceled WHO GMP Certificate of two Maharashtra based WHO-GMP units -
BDH Industries Limited, Mumbai and Sydler Remedies Pvt Limited, Pune.
The
state regulator took action on the basis of Technical Report Series
(TRS) issued by World Health Organisation (WHO) as a part of its
guidelines on auditing and verifying of compliance of WHO- GMP units.
GMPs
is based on a criteria involving factors such as sanitation and
hygiene, qualification and validation, self-inspection, quality audits,
suppliers’ audits, prevention of cross-contamination and bacterial
contamination during production, training employees and personnel.
This
comes at a time when seven drug companies in India with substantial
exposure to the US market, have also disclosed over the last couple of
months that some of their manufacturing facility inspections had reached
successful closure, signaling resumption of supplies and new product
filings to the US.
Four GMP compliance reports were issued to
Indian companies in 2015 compared to an average of around eight in 2011
to 2014. Thirty per cent of quality related warning letters and less
than five per cent drug recalls have also been attributed to Indian
companies, according to official sources.
Maharashtra FDA had
also recently issued show cause notice to a Nashik based firm for not
complying to quality control protocols and good manufacturing practices
(GMPs). It was found during inspection that quality control officers
were absent in the second and third shift and that explosive solvents
like lsopropyl alcohol were stored in open space among other violations.
The firm is a WHO-GMP certified unit and is leading exporter to several countries.
Show
cause notice was served for contravening the provisions of Section 18
(c) Rule 74, 78(p) of the D&C Act and various provisions of Schedule
M Part I and Schedule Ll.
Based on FDA inspection, it was also
found that the firm had not provided separate sampling area for active
raw materials and excipients. Other major contraventions included log
book for equipment were not in place, hygrometers did not have water,
environmental control were not validated periodically, vendor validation
records were not produced during inspection, air condition and lights
were not found in working condition, no temperature and humidity records
were available, overhead and underground water tanks were not cleaned
periodically.
Even as the Central Drugs Standard Control
Organisation (CDSCO) is in the process of upgrading its GMP standards to
meet the requirements of global regulatory markets, Form 483s issued
last year to Indian manufacturing units had a high level of data
integrity issues, pinpoint regulatory experts analysing the trends.
The
originality of the data was not ensured and maintained which according
to experts has led to data integrity issues which ought to be done on a
real time basis. This has led to falsification of data and
manipulations.
Regulators globally during their audit visits at
Indian sites have issued in total 19 Form 483 last year as a part of
their observations on data integrity with the latest made on March 3,
2016 on a leading Indian company.
Several Indian drug makers have
come under the scanner of the global drug regulatory authorities in the
recent years over a range of issues like data integrity, including
production quality, sanitation standards and alleged data manipulation.
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