Audit

Definition of the term ("What is an audit?") An audit checks, if the requirements, processes, and guidelines meet prescribed standards or norms. Due to the high significance of quality, audits…

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EU GMP guideline

The EU GMP guideline summarizes all regulations and operating instructions that have ever been specified for pharmaceutical companies in the Federal Republic of Germany. This guideline and all it annexes…

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FDA 21 CFR Part 11

FDA 21 CFR Part 11 , the American Food and Drug Administration (FDA) specifies requirements for electronic documents, electronic signatures and handwritten signatures applied to electronic documents regarding trustworthiness, reliability,…

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GAMP5

GAMP stands for Good Automated Manufacturing Practice. The number five represents version 5 which is currently the most up-to-date implementation. GAMP5 offers a pragmatic and practical guide for the implementation…

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GMP

GMP stands for “Good Manufacturing Practice” or German “Gute Herstellpraxis”. Thus, GMP contains policies and regulations that always have to be observed, if organizations deal with the production and handling…

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GxP

All guidelines for good working practice, which are particularly important in medicine, pharmacy and pharmaceutical chemistry, are summarised by the abbreviation GxP. The “G” stands for “good(s)” or “Good” and…

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ISO 13485:2016

The ISO 13485 is an ISO norm containing the requirements for a comprehensive management system of the creation of medicinal products. The most recent edition of the norm has been…

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ISO 9001:2015

ISO 9001:2015 defines general principles and terms relating to quality management. It also defines the minimum quality management requirements that an organisation must meet in order to manufacture products that…

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ISO certification

Definition of the term („What does ISO certification mean?“) The ISO certification is a process designed to prove the compliance with certain requirements. For example, ISO 9001 specifies the requirements…

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Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (“Arzneimittel- und Wirkstoffherstellungsverordnung — AMWHV”, section 2, §10, §20)

The German Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients is an ordinance for the implementation of the practice for product with human origin. It was issued…

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Process audit

Definition of the term (“What is a process audit?”) The term process audit describes the evaluation of the quality capability for products, product groups and their processes within the quality…

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Validation

Definition of the term ("What does validation mean?") Validation plays a special role in all regulations of the GxP environment. Fundamentally, the validation means providing a documented proof that a…

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