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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.
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 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.
Our quality assurance system is regularly monitored and audited by the corresponding authorities.
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’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 products which are determined for human use are treated under GMP aspects.Merck 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 products declared as “suitable for use as API”, Merck offers ASMF, DMF, CEP or comparable documentation on request.
GMP for Excipients
All Products at Merck which are determined for human use are treated under GMP aspects.Merck 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 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.
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