GMP & HACCP

As a manufacturer of pharmaceutical active substances and excipients, food additives and other food ingredients as well as active cosmetic substances, Merck operates according to recognized international quality standards and relevant regulations.

These have varying degrees of stringency, depending on the product groups involved, but all follow the same goal of ensuring that the user or consumer is provided with the optimal product quality and best possible safety.

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Food additives in the sense of the Food Laws are substances that, by being used in food production, achieve certain technological effects and thus influence these foodstuffs in terms of their properties. As to whether any particular substance may be defined as a food additive, Merck refers to the official regulations governing food additives.

HACCP Guidelines

European Regulation 852/2004/EC regulates the general hygiene of foodstuffs at all stages of the production chain to ensure hygiene and hence safety of foodstuffs. It requires the manufacturer to establish specific internal control measures and documentation based on the HACCP concept (Hazard Analysis and Critical Control Point) introduced by the FAO/WHO Codex Alimentarius. The HACCP concept includes active control of the processing steps and the working procedures.

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 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.

Essential 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.
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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.