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Система GMP и HACCP

Как производитель активных фармацевтических субстанций и наполнителей, пищевых добавок и других пищевых инградиентов, а также активных косметических субстанций, наша фирма руководствуется утвержденными междунароными стандартами качества и важнейшими инструкциями

Они имеют различные степени строгости, в зависимости от групп вовлеченных продуктов, но все следуют той же самой целью обепечения, что позволяет предоставлять пользователю или потребителю оптимальное качество продукта и самую лучшую безопасность

Merck4Food
Пищевые добавки в смысле Пищевого Закона - вещества, которые будучи используемые в производстве пищевых продуктов, достигают определенных технологических эффектов и таким образом влияют на это продовольствие с точки зрения их свойств. Относительно того, может ли какое-нибудь специфическое вещество быть определено как пищевая добавка, фирма Мерк миллипор обращается к официальным инструкциям по пищевым добавкам. HACCP нормативы Европейское Правило 852/2004/EC предписывает общую гигиену продовольствия на всех стадиях цепи производства, чтобы гарантировать гигиену и следовательно безопасность продовольственных товаров. Это требуется для того, чтобы изготовитель установил определенные внутренние меры контроля и документацию, основанную на понятии HACCP (Анализ Опасности и Точки Критического Контроля) введенный FAO/WHO (Организацией ООН по продовольствию и С/Х и Всемирной Организацией Здравоохранения) Пищевой Кодекс. Концепт HACCP включает активный контроль производственных этапов и рабочих процедур. Since counter-measures to be taken in any specific case are documented individually for each control point and personnel responsibilities are clearly defined, potential dangers and deviations from established standards may be identified in advance. Thus it is possible to solve problems at the first indication, before they can exert any influence on the safety or quality of the product involved. Good Manufacturing Practices – GMP and GMP Compliance GMP and GMP compliance as practiced at Merck Millipore comprise several additional aspects, such as the design of the product, its traceability, the release analysis and the comprehensive documentation of all procedures. The quality assurance system is based on risk management for technical systems and production plants, qualification of plants, control of processes, cleaning procedures and analytical methods. Microbiological monitoring of the demineralized water used and, if necessary, the production plant itself, the rooms used and the personnel involved is also carried out. All of our plant staff are properly qualified and correspondingly trained in the use of the equipment involved. All steps of the working procedure are individually documented in SOPs. In-process controls are carried out to monitor and control all production steps. The final products are subjected to analysis of the predefined specifications before being released. Существенные цели нашей GMP - философии, это исключение путаницы на всех производственных этапах включая конечный продукт и предотвратить все биологические, химические и физические загрязнения. Наша система прверки качества регулярно проверяется и ревизуется соответствующими органами. Since 1971, we have been subjected to inspection by the FDA (the US Food and Drug Administration), 20 times in all. Regarding the production of medicinal products, we are regularly inspected by the Regional Authorities in Darmstadt. So far without any major complaints. Merck Millipore’s high quality and safety is also confirmed by annually 70 audits carried out by our customers in the pharmaceutical, cosmetic and food industries.

Merck4Food

Пищевые добавки в смысле Пищевого Закона - вещества, которые будучи используемые в производстве пищевых продуктов, достигают определенных технологических эффектов и таким образом влияют на это продовольствие с точки зрения их свойств. Относительно того, может ли какое-нибудь специфическое вещество быть определено как пищевая добавка, фирма Мерк миллипор обращается к официальным инструкциям по пищевым добавкам.

HACCP нормативы
Европейское Правило 852/2004/EC предписывает общую гигиену продовольствия на всех стадиях цепи производства, чтобы гарантировать гигиену и следовательно безопасность продовольственных товаров. Это требуется для того, чтобы изготовитель установил определенные внутренние меры контроля и документацию, основанную на понятии HACCP (Анализ Опасности и Точки Критического Контроля) введенный FAO/WHO (Организацией ООН по продовольствию и С/Х и Всемирной Организацией Здравоохранения) Пищевой Кодекс. Концепт HACCP включает активный контроль производственных этапов и рабочих процедур.

Since counter-measures to be taken in any specific case are documented individually for each control point and personnel responsibilities are clearly defined, potential dangers and deviations from established standards may be identified in advance. Thus it is possible to solve problems at the first indication, before they can exert any influence on the safety or quality of the product involved.

Good Manufacturing Practices – GMP and GMP Compliance
GMP and GMP compliance as practiced at Merck Millipore comprise several additional aspects, such as the design of the product, its traceability, the release analysis and the comprehensive documentation of all procedures.
The quality assurance system is based on risk management for technical systems and production plants, qualification of plants, control of processes, cleaning procedures and analytical methods.
Microbiological monitoring of the demineralized water used and, if necessary, the production plant itself, the rooms used and the personnel involved is also carried out.

All of our plant staff are properly qualified and correspondingly trained in the use of the equipment involved. All steps of the working procedure are individually documented in SOPs. In-process controls are carried out to monitor and control all production steps. The final products are subjected to analysis of the predefined specifications before being released.

Существенные цели нашей GMP - философии, это исключение путаницы на всех производственных этапах включая конечный продукт и предотвратить все биологические, химические и физические загрязнения.

Наша система прверки качества регулярно проверяется и ревизуется соответствующими органами.

Since 1971, we have been subjected to inspection by the FDA (the US Food and Drug Administration), 20 times in all. Regarding the production of medicinal products, we are regularly inspected by the Regional Authorities in Darmstadt. So far without any major complaints. Merck Millipore’s high quality and safety is also confirmed by annually 70 audits carried out by our customers in the pharmaceutical, cosmetic and food industries.

Merck4Pharma
Active pharmaceutical substances and additives are subject to GMP regulations as defined by 21 CFR parts 210 and 211 of the US Code of Federal Regulation and other European regulations and guidelines. Meanwhile, the current regulations for active substances and additives have been put into force (ICH Guide Q7 and Annex 2). The basis of our quality assurance system is risk management for technical systems and production plants, qualification of plants, validation of processes, cleaning procedures and analytical methods. С нормами ISO 22716 “Косметические-GMP-нормативы на GMP”, 15.11.07, международный стандарт для косметического GMP был основан. All of our plant staff are properly qualified and correspondingly trained in the use of the equipment involved. All working procedures are documented in SOPs. In-process controls are carried out to monitor and control all production steps. And, of course, the final products are subjected to analysis of predefined specifications before being released. The main goals of our GMP philosophy are the exclusion of mix-ups in all production steps up to and including the final product and the avoidance of all biological, chemical and physical contamination. Наша система прверки качества регулярно проверяется и ревизуется соответствующими органами. Since 1971, we have been subjected to inspection by the FDA (the US Food and Drug Administration), 20 times in all. Regarding the production of medicinal products, we are regularly inspected by the Regional Authorities in Darmstadt. So far without any major complaints. Merck Millipore’s high quality and safety is also confirmed by annually 70 audits carried out by our customers in the pharmaceutical, cosmetic and food industries. GMP for Active Pharmaceutical Ingredients (API’s) All Merck Millipore products which are determined for human use are treated under GMP aspects. Merck Millipore products declared as “suitable for use as API” fulfill the requirements of the European GMP Guide for the manufacturing of drug products part II, active substances (ICH Q7). For Merck Millipore products declared as “suitable for use as API”, Merck Millipore offers ASMF, DMF, CEP or comparable documentation on request. GMP for Excipients All Products at Merck Millipore which are determined for human use are treated under GMP aspects. Merck Millipore products declared as “suitable for use as excipients” fulfill all GMP requirements for excipients (according to the joint IPEC-PQG GMP Guide for pharmaceutical excipients 2006 and USP chapter 1078) For EMPROVE^® products an extensive documentation in line with module 3 CTD structure is available. GMP certificates Active pharmaceutical ingredients (API’s) may be inspected by the authorities based on Directive 2001/83/EC as amended by Directive 2004/27/EC. Only for Merck Millipore products declared as “suitable for use as API” and which have been inspected by the authority, a GMP certificate is available on request. For API’s not yet inspected by the authority and for excipients a GMP certificate is not available.

Merck4Pharma

Active pharmaceutical substances and additives are subject to GMP regulations as defined by 21 CFR parts 210 and 211 of the US Code of Federal Regulation and other European regulations and guidelines. Meanwhile, the current regulations for active substances and additives have been put into force (ICH Guide Q7 and Annex 2).

The basis of our quality assurance system is risk management for technical systems and production plants, qualification of plants, validation of processes, cleaning procedures and analytical methods.

С нормами ISO 22716 “Косметические-GMP-нормативы на GMP”, 15.11.07, международный стандарт для косметического GMP был основан.

All of our plant staff are properly qualified and correspondingly trained in the use of the equipment involved. All working procedures are documented in SOPs. In-process controls are carried out to monitor and control all production steps. And, of course, the final products are subjected to analysis of predefined specifications before being released.

The main goals of our GMP philosophy are the exclusion of mix-ups in all production steps up to and including the final product and the avoidance of all biological, chemical and physical contamination.

Наша система прверки качества регулярно проверяется и ревизуется соответствующими органами.

Merck Millipore’s high quality and safety is also confirmed by annually 70 audits carried out by our customers in the pharmaceutical, cosmetic and food industries.

GMP for Active Pharmaceutical Ingredients (API’s)
All Merck Millipore products which are determined for human use are treated under GMP aspects. Merck Millipore products declared as “suitable for use as API” fulfill the requirements of the European GMP Guide for the manufacturing of drug products part II, active substances (ICH Q7).

For Merck Millipore products declared as “suitable for use as API”, Merck Millipore offers ASMF, DMF, CEP or comparable documentation on request.

GMP for Excipients
All Products at Merck Millipore which are determined for human use are treated under GMP aspects. Merck Millipore products declared as “suitable for use as excipients” fulfill all GMP requirements for excipients (according to the joint IPEC-PQG GMP Guide for pharmaceutical excipients 2006 and USP chapter 1078)

For EMPROVE^® products an extensive documentation in line with module 3 CTD structure is available.

GMP certificates
Active pharmaceutical ingredients (API’s) may be inspected by the authorities based on Directive 2001/83/EC as amended by Directive 2004/27/EC.

Only for Merck Millipore products declared as “suitable for use as API” and which have been inspected by the authority, a GMP certificate is available on request. For API’s not yet inspected by the authority and for excipients a GMP certificate is not available.

Merck Chemicals

Система GMP и HACCP