Quality Standards

Quality Standards (GMP Certificate)

Manufacturing & Sales of PEKANA  Remedies are performed under ‘State of the art Quality Standards’.

PEKANA Naturheilmittel GmbH has been certified in compliance with the guidelines of Good Manufacturing Practice (G.M.P). The company has also been successfully inspected by the American Food and Drug Association (FDA). The AEO  F certificate issued by Customs grants the status of authorised economic operator.

Good Manufacturing Practice (GMP)

Good Manufacturing Practice comprises various national and international guidelines, laws and regulations to assure the quality of the manufacturing and packaging processes of drugs and remedies applicable for all pharmaceutical manufacturers and defining a wide range of requirements to the manufacturing plant. The modes of implementation of the respective enterprise are completely documented in a comprehensive quality management system. Quality assurance applies to the following areas:

– Staff
– Company rooms and facilities
– Documentation
– Manufacture
– Testing
– Labelling
– Storage and transportation
– Hygiene standards
– Self-inspection of the system in order to continuously improve quality management
Control of adhering to these guidelines as well as the legally binding certification is done by the control authority responsible (District Government).

Food and Drug Administration (FDA)

Food and Drug Administration is responsible for supervising food and drug registration in the United States. It is FDA’s task to protect public health in the USA. FDA poses comparatively high requirements to the quality standards of the production of pharmaceuticals such as the GMP certificate. FDA reviews the fulfillment of the requirements to the manufacture as well as the company facilities based on the legal terms and regulations of the Code of Federal Regulation (CFR), a highly detailed and strict body of rules. FDA reviews pharmaceutical enterprises in Germany which import pharmaceuticals into the USA. Lacking an accordingly positive outcome renders importation impossible.

Authorised Economic Operator full (AEO F)

Increasing globalization and the changing international security situation have caused the World Customs Organization (WCO) to develop a framework of standards to secure and facilitate global trade (SAFE) and so warrant an effective risk management in customs authorities. Objective is to effectively protect global delivery chains from the manufacturer of goods up to the end consumer, in particular with goods trade across borders. The AEO certificate is an international quality mark. It focusses on subjects meant to facilitate and secure customs regulations. In order to meet these requirements an enterprise has to fulfill appropriate security standards to warrant the protection of goods. Legal requirements mainly arise from article 5a customs code and article 14a – 14x customs code executive order.