Swiss
pharma Nigeria Limited (swipha) manufactures and marketspharmaceutical products
that meet international standards.
Swipha also distributes products of other international pharmaceutical
companies like: Bayer AG, Germany (OTC Products) BIO-STRATH AG., Switzerland
amongst others.
Swipha
has been in Nigeria since 1976 and has been supplying drugs to Federal Ministry
of Health, State Governments and Parastatals. Continue..
Swipha also sells to the private sector and many of her products are
household names in Nigeria. All the
products manufactured in her plant at No. 5, Dopemu Road Agege, Lagos are
subject to current Good Manufacturing Practice (cGMP) and Good Laboratory
Practice (GLP) for Quality Control.
Swipha
has always been in the forefront of quality in her systems, processes and
products. In 1993 swipha embarked upon a
companywide implementation of Total Quality Management ( TQM) as part of her
continual quality improvement. This
strategic move helped to entrench quality as a culture in the organization. The
effect of this on the performance of the company was remarkable. As time went by the Management of swisspharma
Nigeria Limited(swipha) decided to embark upon ISO:2000 QMS Certification for
her Quality Management System. This was
at a time that many other companies made do with basic quality standards.
In
the year 2004, swipha became the first in the Pharmaceutical Industry in
Nigeria to attain this certification which further entrenched her leadership in
quality systems and products.
By
then swipha has built an enviable reputation of quality which was acclaimed by
professionals in the healthcare delivery system of the country.
Buoyed
by the attainment of the ISO 9001:2000 QMS Certification, swipha went ahead to
obtain a higher version of the certification which is NIS ISO 9001:2008.
Swipha
developed a corporate philosophy that nothing being done is “too good” that it
cannot be improved upon. Recognizing
that change is a constant thing in life, swipha braced up for higher
challenges.
About
this time, many Global Donor Agencies were procuring pharmaceutical commodities
from Europe. These were deployed to many
countries of which Nigeria was one.
However, proposals sent to some of these agencies soliciting patronage by swipha were not granted on the
basis that they source products only from WHO GMP Certified companies. At that time only two companies in Africa
were so certified. Swipha saw this as a
challenge.
In
2006 the Management of swissPharma Nigeria Limited (swipha) decided to pursue
WHO Prequalification for her Anti-malarial product – DART (the first of its
class to be produced in Nigeria). Then
Nigeria had just launched a new Treatment Policy Guideline (2005) for the
treatment of uncomplicated malaria which did away with the first line products
(Chloroquine and Sulphadoxine/Pyrimethamine).
Also, all monotherapies were to be dropped. On her own volition, swipha discontinued the
production of her then newly introduced anti-malarial (ARENAX 50mg) which was
also the first of its class to be manufactured in Nigeria.
From
then on, a flurry of activities and projects followed. In 2008 a major modification/modernization of
swipha’s manufacturing factory/laboratory commenced. This led to a complete redesigning and
upgrading of the plant and lab to modern internationally acceptable
standards. The company also embarked on
acquisition of modern machines and laboratory equipment to complement the new
factory.
At
this point, the company had to engage international consultants to carry out
preparatory third party audits with WHO pre-qualification in view. This, as can be imagined , was a slow but
steady push as the company was going it all alone in a resource poor
environment.
This
was the situation until 2012 when the leadership of NAFDAC in collaboration
with PMG-MAN convinced the WHO to initiate a new concept which was piloted in
Nigeria for the organization of GMP Inspections as a follow up of Technical
Assistance.
This
concept involves organizations of pre-submission of GMP Audits by WHO Pre-qualification team (WHOPQT) Inspectors to verify status of
compliance achieved during previous Technical Assistance, although completion
of data to be submitted for pre-qualification in line with international
standards is still ongoing.
Swipha
was selected as one of the eight companies in Nigeria shortlisted for a GAP
Analysis to ascertain the level of compliance to the WHO cGMP standards based
on initial evaluation of her Site Master File.
This
heralded series of Advisory Audits by NAFDAC to further enhance compliance to
WHO cGMP standards and preparedness for the final WHO cGMPInspction which took
place in April 2013. A further
verification inspection was carried out
in October 2013. By this time, most of
the identified GAPS (Non-Conformances) has been closed. It is important to note that throughout the
inspection and close out of GAPS, no critical observation (defined as a major
violaton of GMP Standard or Guideline) was observed.
The
other remaining non-conformances were closed out and further verified by NAFDAC
in February, 2014.
On
April 2, 2014 the World Health Organisation (WHO) declared swipha’s
Manufacturing and Laboratory Facility as being compliant to the WHO cGMP.
This
brought to a temporary end the“journey of a thousand miles” and placed swipha
(and indeed Nigeria) on the world map as the First company in West Africa to be
so acknowledged.
This
feat is indeed an attestation to swipha’s commitment to quality. It has further instilled more confidence in
the consumers with regards to the products manufactured by swipha. It is therefore expected that swipha’s
products will be patronized more than ever before.
A
window of opportunity is also opened for quality conscious international donor
agencies and governments to procure from a Nigerian Pharmaceutical Company
drugs intended for use in Nigeria and Africa.
Swipha’s
drive for export is further boosted as her reputation now goes beyond
Nigeria. Equally contract manufacturing
business for multinationals which swipha had been hitherto engage in is
expected to increase in volume and numbers.
Indeed
the journey holds a lot of promise as swipha is determined to remain a top
quality key player in the industry.
16 comments:
When i hear swipha, i think drugs.
CoolDiva speaks!
Congratulations.
Okay
XDON D DON
Ok #bright bravo#
Nice one.
Congrats to Swipha.
My swipha!!!!
Great!
Swipha #thumbsup on that
Pics of their facility nko? Abi na grammer dem wan knack us only. Congrats Swipha cos getting cGMP certification aint easy.
It's very encouraging to read news like this about Nigeria. As a pharmacist in the UK, I more than ever want to go back home and contribute positively to the growing economy. Congratulations Swipha!
Adeola
It is very encouraging to read news like thus about Nigeria. As a pharmacist based in the UK, I so much look forward to coming home and contributing positively to the economy of our nation. Congratulations Swipha!!
But una products too bitter
nice One! good to be part of the team
nice blog!! it's really interested to know about Who-Gmp Certification India
nice blog about Who-Gmp Certification India
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