Во вложение скан копия регистрацион

Во вложение скан копия регистрационного свидетельства. Сегодня я отправлю документы курьерской службой.
Но есть замечание и это очень важно.
Регуляторный орган сделал серьеозное замечание по методике "Microbiological quality" и мы должны предоставить ответ в течении 30 дней. Если мы не предоставим ответ, то не сможем пройти лабораторный контроль при следующей поставке, а значит не сможем продавать. Мы получили регистрационное свидетельство с условием , что устраним это замечание..Нам нужна валидация методики "Microbiological quality" по действующему изданию Европейской фармакопеи или Протокол проверки воспроизводимости методики "Microbiological quality" по действующему изданию Европейской фармакопеи. Ниже я прикрепляю скан. станиц с данной фармакопеи.
Второй момент - после того, как Вы подтвердите воспроизводимость методики по по действующему изданию Европейской фармакопеи и получите результаты - нужны 3 обновленные сертификата качества с новыми показателемя
"Общее число аэробных микроорганизмов (ТАМС) не более 103 КОЕ/г; Общее число дрожжевых и плесневых грибов (TYMC) не более 102 КОЕ/г;
Отсутствие Escherichia coli в 1 г препарата."

Упаковка для следующей поставки будет такая же. Ведь мы забираем остаток 25 000. новую упаковку согласуем уже в январе.

Результаты (английский) 1:

The attachment scan of a copy of the registration certificate. Today I will post the documents by courier.But there is a comment and that is very important.Regulatory body made a ser′eoznoe comment on how "Microbiological quality and we must provide a response within 30 days. If we don't provide the answer, you will not be able to pass a laboratory control on the next delivery, and therefore will not be able to sell. We received a certificate of registration on the condition that will fix this is. ..We need the validation of Microbiological methods "quality" on the current edition of the European Pharmacopoeia, or Protocol verification of reproducibility of methods "Microbiological quality" on the current edition of the European Pharmacopoeia. Below I attach a scan. pages with the pharmacopoeia.The second time-after you confirm the reproducibility of the method according to the current edition of the European Pharmacopoeia and get results-need 3 upgraded quality certificate with the new pokazatelemâ "The total number of aerobic microorganisms (TAMs) not more than 103 cfu/g; The total number of yeast and fungi (TYMC) not more than 102 cfu/g; The absence of e. coli in 1 g of the product. "Packing for the next delivery will be the same. We pick up the balance of 25000. the new packaging will have in January.

Результаты (английский) 2:

The attachment scanned copy of the registration certificate. Today, I will send the documents by courier.
But there is a remark which is very important.
The regulator did sereoznoe note on methodology "Microbiological quality" and we must respond within 30 days. If we do not give the answer, we can not go through laboratory testing at the next delivery, and therefore will not be able to sell. We have received a certificate of registration with the condition that it will eliminate zamechanie..Nam need validation techniques "Microbiological quality" according to the current edition of the European Pharmacopoeia or protocol test the reproducibility of the methodology "Microbiological quality" according to the current edition of the European Pharmacopoeia. Below I attach the scan. villages with this Pharmacopoeia.
The second time - after you confirm the reproducibility of the technique on to the current edition of the European Pharmacopoeia and get results - need 3 updated with new quality certificate pokazatelemya
"The total number of aerobic microorganisms (TICA) is not more than 103 CFU / g total the number of yeasts and molds (TYMC) not more than 102 CFU / g;
lack of Escherichia coli in 1 g of the drug. " Packing for the next delivery will be the same. After all, we take the rest of 25 000 new packaging coordinate in January.

Результаты (английский) 3:

In the attachment scan copy of certificate of registration. Today I will send documents by courier.
but there is a comment and this is very important.
Eastern Caribbean Central Bank made a серьеозное comment on the procedure "Miсrоbiоlоgiсаl quality" and we must provide a response within 30 days. If we do not provide the answer,It will not be able to pass the laboratory control when the next delivery, and therefore will not be able to sell. We have received a certificate with the condition, that eliminate this comment..We need a validation methodology "Miсrоbiоlоgiсаl quality" on the current edition the European Pharmacopoeia or Protocol check repeatability method "Miсrоbiоlоgiсаl quality" on the current edition the European Pharmacopoeia.Below, i прикрепляю scan. pages with this pharmacopoeia.
the second time - afterAs soon as you confirm repeatability methodologies for the current edition of the European Pharmacopoeia and get results - need 3 updated certificate quality with new показателемя
"The total number of aerobic micro-organisms (ТАМС) is not more than 103 I/g; the total number of vitamins "b". And плесневых mushrooms (TYMC) is not more than 102 I/g;
No Escherichia coli in 1 g drug. "Lord packaging for the next delivery will be the same.We have contracted the balance 25 000. The new packaging shootings already in January.