ElMaestro
★★★

Denmark,
2018-01-17 14:22
(2262 d 03:06 ago)

Posting: # 18188
Views: 6,670
 

 For the sake of citizens or a high-level retaliatory activity? [GxP / QC / QA]

Hi all,

I read this with quite some degree of wonder.

I can see why any country would like to inspect facilities overseas in order to protect in the interest of its own citizens.
However, at his point I could also be afraid that the initiative is entirely a retaliatory effort? They got nowhere with lobbying, diplomacy and semi-dirty accusatory remarks targeted at select individual regulatory employees in EU and US. Likewise, taking pity on themselves and arguing they have fallen victim to an international conspiracy intended to bring the industry to its knees didn't work.
This could escalate the situation very considerably.

What do you think? I apologise if this is a very politically incorrect question. But I really, honestly am puzzled and worried.

Pass or fail!
ElMaestro
Helmut
★★★
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Vienna, Austria,
2018-01-17 14:44
(2262 d 02:43 ago)

@ ElMaestro
Posting: # 18189
Views: 5,829
 

 Act of revenge?

Hi ElMaestro,

❝ I read this with quite some degree of wonder.


Fascinating!

❝ However, at his point I could also be afraid that the initiative is entirely a retaliatory effort?


My impression as well.

❝ Likewise, taking pity on themselves and arguing they have fallen victim to an international conspiracy intended to bring the industry to its knees didn't work.

❝ This could escalate the situation very considerably.


Well, I don’t think that US manufactures which are regularly inspected by the FDA will tremble with fear when inspectors of the CDSCO wearing tin foil hats will enter their facilities.

❝ I apologise if this is a very politically incorrect question.


This forum is not (strictly) bound to political correctness.

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d_labes
★★★

Berlin, Germany,
2018-01-17 16:59
(2262 d 00:29 ago)

@ Helmut
Posting: # 18193
Views: 5,924
 

 OT: Tinfoil hat

Dear All,

❝ Well, I don’t think that US manufactures which are regularly inspected by the FDA will tremble with fear when inspectors of the CDSCO wearing tin foil hats will enter their facilities.


if you, like me, never heard that curious "tinfoil hat" have a look in the Urban dictionary.
My favorite is definition number 3 :-D.

Regards,

Detlew
mittyri
★★  

Russia,
2018-01-17 22:40
(2261 d 18:48 ago)

@ Helmut
Posting: # 18197
Views: 5,831
 

 GMP certificate from Russia with love

Hi Helmut,

❝ Well, I don’t think that US manufactures which are regularly inspected by the FDA will tremble with fear when inspectors of the CDSCO wearing tin foil hats will enter their facilities.


Indeed some time ago a service was created in Russia for independent GMP inspection.
FDA? EMA? No, if you want to manufacture the substances/IMP for Russia, you need to get Russian GMP certificate (will be raised to EAUnion level soon)

Indian and European (HUGE European) manufacturers filed an application for GMP inspection immediately ("We spent thousands of hours with FDA/EMA inspectors, we can teach Russians to inspect in proper manner!")
You know what?
For non-speakers:
At 21th of July, 2016 Russian GMP certificates were given to 3 (THREE) foreign companies, 16 (SIXTEEN) companies are refused.
There are no public data regarding the reasons of refusal, only some roumors.
Some colleagues told me that the main reason is disrepancy between Russian and original documentation (was no up-to date).
Head of inspectors said:
The manufacturers are getting used to use desktop-oriented approach. 27% of findings are related to documentation.
There are some cases with no validation of processes.
There is a case with no (!) manufacturing line.
There are some cases with no data regarding abnormal toxicity tests performed but provided with submission.

Kind regards,
Mittyri
Beholder
★    

Russia,
2018-01-18 08:53
(2261 d 08:35 ago)

@ mittyri
Posting: # 18198
Views: 5,818
 

 GMP certificate from Russia with love

Hi Mittyri,

❝ Indian and European (HUGE European) manufacturers filed an application for GMP inspection immediately ("We spent thousands of hours with FDA/EMA inspectors, we can teach Russians to inspect in proper manner!")


Also here.

“The situation with the inspection of foreign sites is diametrically opposite. In 2016-2017, 1167 applications were submitted to the Ministry of Industry and Trade, 589 inspections were carried out, 497 conclusions were issued. Almost 25% of manufactures were refused. The largest share of failures is accounted for manufactures located in Europe, »which, I emphasize, have been living for several decades in the regime of existence of regulatory requirements for production and inspection», Vladimir Shipkov commented.”

And some real examples from the head of Association of International Pharmaceutical Manufactures which represents the interests of foreign companies in Russia:
“The head of the AIPM cited examples of violations that were recorded by Russian inspectors: »Racks and floors are covered with a large layer of dust», »the fact of using chewing gum by a senior chemist is noted», »the laboratory has windows that are not identified as emergency exits.»” Looks funny, especially about gum :lol:.

However the representative from the Ministry answered:
“»Each time, assessing the degree of risk, we evaluate the entire set of comments. And when we see on the European site that by chance or negligence the manufacturer has made appropriate changes to the dossier for one country, and for Russia has not, and it means, the tablets are actually produced in India on an unknown site. When such situations arise, the question arises: how does the producer relate to the country where he delivers the drug? Does he have respect, responsibility? Probably not. This is expressed in the statistics that you give», – he said.”

Last paragraph is quite tough.

So, looks like the child is going to teach Daddy?

Best regards
Beholder
Helmut
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Vienna, Austria,
2018-01-18 15:23
(2261 d 02:05 ago)

@ Beholder
Posting: # 18208
Views: 5,778
 

 Don’t you believe it!

Hi Beholder,

to set the paragraph you quoted into perspective, the preceding one:

“Association AIPM analyzed results of inspections of Russian and foreign sites. In 2015–2017, local manufacturers were issued 187 GMP certificates, the number of failures – zero.”

❝ “The situation with the inspection of foreign sites is diametrically opposite. In 2016-2017, 1167 applications were submitted to the Ministry of Industry and Trade, 589 inspections were carried out, 497 conclusions were issued. Almost 25% of manufactures were refused. The largest share of failures is accounted for manufactures located in Europe, »which, I emphasize, have been living for several decades in the regime of existence of regulatory requirements for production and inspection», Vladimir Shipkov commented.”


local    <- c(0, 187)
European <- c(124, 497-124)
GMP      <- matrix(c(local, European), nrow=2,
                   dimnames=list(guess=c("local", "European"),
                                 truth=c("local", "European")))
ft       <- fisher.test(GMP, alternative="less")
cat("Failures (%)",
    "\nEuropean:", sprintf("%4.1f%%",
       100*European[1]/sum(European)),
    "\nlocal   :",
       sprintf("%4.1f%%", 100*local[1]/sum(local)),
    "\n\n"); print(GMP); print(ft)

Failures (%)
European: 24.9%
local   :  0.0%

          truth
guess      local European
  local        0      124
  European   187      373

        Fisher's Exact Test for Count Data

data:  GMP

p-value < 2.2e-16
alternative hypothesis: true odds ratio is less than 1

95 percent confidence interval:
 0.00000000 0.04949719
sample estimates:
odds ratio
         0


❝ So, looks like the child is going to teach Daddy?


A likely story! SCNR. :-D

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Beholder
★    

Russia,
2018-01-18 16:03
(2261 d 01:25 ago)

@ Helmut
Posting: # 18209
Views: 5,759
 

 Don’t you believe it!

Hi Helmut,

❝ to set the paragraph you quoted into perspective, the preceding one:


You caught me)

❝ “Association AIPM analyzed results of inspections of Russian and foreign sites. In 2015–2017, local manufacturers were issued 187 GMP certificates, the number of failures – zero.”


Yes, possibly another lever in West-East competition. But how to separate real fraud, negligance from politic games?! Which tool must be used?!

Best regards
Beholder
Helmut
★★★
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Homepage
Vienna, Austria,
2018-01-18 16:13
(2261 d 01:15 ago)

@ Beholder
Posting: # 18211
Views: 5,795
 

 ☠ ☢ ☣

Hi Beholder,

❝ Yes, possibly another lever in West-East competition. But how to separate real fraud, negligance from politic games?! Which tool must be used?!


When it comes to politics I’m not the right person to answer. At least not in public. My personal opinions about politics generally are not – ehm – politically correct. :angry:

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Helmut Schütz
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Beholder
★    

Russia,
2018-01-18 16:23
(2261 d 01:05 ago)

@ Helmut
Posting: # 18212
Views: 5,705
 

 ☠ ☢ ☣

Hi Helmut,

❝ When it comes to politics I’m not the right person to answer.


Only rhetorical questions. Only rhetorical. ;-)

Best regards
Beholder
nobody
nothing

2018-01-18 11:13
(2261 d 06:15 ago)

@ ElMaestro
Posting: # 18203
Views: 5,782
 

 For the sake of citizens or a high-level retaliatory activity?

...if you read inspections reports from US facilities (finding canisters with pee in production areas, incredible conditions in sterile production andandand...) in the context of appalling rates of product withdrawals due to microbiological contamination or "particulate matter" in solution for parenteral use (just as an example) every additional inspection of any production facility anywhere in the world has to be highly appreciated.

Keep the pressure high to stop quality from deteriorating.

I think it's very difficult to answer, where you get the most bang for the buck when it comes to pharma inspections. The whole system is so totally borked by putting ever more financial pressure on the production imho...


Edit: Please don’t shout! [Helmut]

Kindest regards, nobody
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