[e-drug] External GMP Audits and Certification

["Murtada Sesay" <msesay@unicef.org>]

E-DRUG: External GMP Audits and Certification
------------------------------------------------------------------------

Dear e-drug friends,

I would like to share with you some personal 2008 reflections, based on
some lessons learned over the last few years technically evaluating bids
for medicines procurement.

On the one hand, I have seen an apparent increase in the number of
medicines manufacturers in developing countries, collaborating with
Medicines Regulatory Authorities in developed countries (Europe, USA,
Australia, and Asia) to audit their facilities, for one reason or the
other I have also pleasantly learnt about more National Regulatory 
Authorities (NRAs) in developing countries carrying out their own cGMP 
audit of external medicine manufacturers, and compiling "black" and
"white" lists. Although it is not always clear who pays, and therefore
the degree of vulnerability to conflicts of interest, cGMP audits, by
external parties, regardless of outcome, should always be welcome,
especially by procurement agents, as a basis of medicines quality
improvement or assurance. What is also not clear from the "certificates"
or reports I have seen is whether or not a cGMP audit carried out by an 
external Regulatory Authority, is done with NRA participation/endorsement/
acknowledgement.

The independent auditing of manufacturers located in foreign countries by
developing country NRAs is, in my view, a double edged sword. If done well,
backed with the required technical and financial competence and credibility,
it can enhance quality. However, if done only in exercise of national
sovereignty , but not necessarily backed with independent finance, technical
competence, or credibility, can actually jeopardise quality and create a false sense of assurance - that's not the way to cut!

About a year or so ago, I shared with interested e-drug colleagues an
article I had written on UNICEF's experience in Bangladesh, where we have
been very actively involved for several years of sponsoring cGMP audits, at
our own cost, to support our local procurement capacity. In every case, we
have sponsored these audits with the participation and acknowledgement, not
necessarily endorsement, of the National Drug Regulatory Authority. Also,
whenever possible, in collaboration with the national WHO office, we have
used the opportunity of a sponsored cGMP audit to run workshops/seminars
(one day) for National Regulatory Authority as well as Local Industry
personnel, as part of an overall cGMP capacity development strategy. This
has mainly added value, with insignificant additional cost implication.

I think that not involving the NRA in cGMP audits by external parties, if
this is indeed the case, is an avoidable pitfall. I have already seen
one case where an NRA has black-listed a foreign company as non
cGMP-compliant, even though a reputable ("stringent" seems to be the
operative parlance!!) foreign Regulatory Authority had given a clean bill
that is still valid. This can be confusing and potentially a source of
conflict for all concerned. The fact that many other non cGMP-related
factors sometimes enters the equation, compounds the problem. Whilst I
appreciate that the conclusion of an audit is the prerogative of an
auditor, I do also believe that the responsibility of national drug
regulatory control is a sovereign one which rests squarely on the NRA.

I close by saying that every time I have listened to medicines quality
assurance experts describe their experiences in different parts of the
world, my conviction is reinforced that the way forward for sustainable
medicines quality improvement, globally, is definitely one of strengthening
National Drug Regulatory Authorities, at every opportunity. We should strive
to remove the element of cGMP audits being seen merely as a "policing"
issue which creates more of fear and apprehension, than the positive work
culture change required for consistently and subconsciously building quality
into a product.

Murtada M. Sesay
Technical Specialist (Pharmaceuticals)
UNICEF Supply Division

Tel: +45 3527 3098
Mobile: +45 28 23 28 07
E-mail: msesay@unicef.org
Web: www.unicef.org/supply