Your portal for pharmaceutical and biotech terminology
On info-pharma.de, our young team collects definitions and technical terms relating to pharma, biotech and clinical trials to help newcomers to the field get off to a quick start. With our information site, we want to help interested readers gain a quick insight into this subject area and, above all, provide an overview of the specific terminology used in the pharmaceutical and biotech industry.
Topics
Terms from pharmacy and biotech
Pharmacy
Pharmacy deals with the composition, effect, development, testing, manufacture and dispensing of medicinal products.
Read more →BtBiotech
Biotechnology is the technical use of enzymes, cells and complex organisms in the manufacture of medicines.
Read more →GxPGxP
In both the pharmaceutical and the biotech industry, the approval of a medicine is subject to strict GxP requirements.
Read more →GLPGLP
The term Good Laboratory Practice (GLP) describes the formal framework for conducting safety studies.
Read more →GMPGMP
The term Good Manufacturing Practice (GMP) covers various guidelines for production processes and environments.
Read more →DMSDocument Management Systems
The term document management system describes database-supported software whose aim is to support internal document management.
Read more →OutOutsourcing/Decentralisation
The term outsourcing can be understood as a business strategy in which individual processes of a company are outsourced.
Read more →RARegulatory Requirements
In both the pharmaceutical and the biotech industry, the approval of a medicine is subject to strict regulatory requirements.
Read more →In-depth articles
Regulatory affairs and clinical research in detail
GCPGCP: What Good Clinical Practice Means and How Software Supports Compliance
Good Clinical Practice explained: aims, history, ICH E6(R3) with effective dates in the EU, US and UK, legal framework, roles, inspection findings and software-supported compliance.
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21 CFR21 CFR Part 11 and Electronic Signatures: Requirements, Scope and Implementation
21 CFR Part 11 explained: scope, requirements for electronic records and signatures, clinical investigations, comparison with EU GMP Annex 11 and eIDAS, typical findings.
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CSVComputer System Validation (CSV): Fundamentals, Regulatory Requirements and Validation of Cloud Software in the GxP Environment
Computer system validation in GxP: Annex 11, 21 CFR Part 11, GAMP 5, CSA, the validation lifecycle, cloud and SaaS validation, pre-validated software and inspection findings. Status November 2026.
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ALCOAData Integrity and ALCOA+: Principles, Regulatory Requirements and Implementation in the GxP Environment
Data integrity and ALCOA+ explained: ALCOA, ALCOA+ and ALCOA++ compared, FDA, MHRA, PIC/S, WHO and EMA expectations, electronic systems and typical findings.
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TMFTMF and eTMF: What the Trial Master File Is and Which Requirements Apply to Keeping It Electronically
Trial master file and eTMF: definition, legal basis (EU CTR, EMA guideline, ICH E6(R3), 21 CFR 312), TMF Reference Model, eTMF requirements and inspection findings.
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GDocPGxP Document Control and Good Documentation Practice: Requirements for the Life Cycle of Controlled Documents
GxP document control and Good Documentation Practice: regulations, document hierarchy, life cycle of controlled documents, GDocP rules, eDMS and inspection findings.
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CROCRO Sponsor Oversight: How Sponsors Ensure Oversight of Outsourced Trial Activities
Sponsor oversight of CROs: ICH E6(R3), EU Regulation 536/2014, 21 CFR 312.52, TORO, oversight plans, KPIs, audits, inspection findings and practical advice for small sponsors. Status November 2026.
Read more →Regulatory Requirements
GxP, GLP and GMP
In both the pharmaceutical and the biotech industry, the approval of a medicine is subject to strict regulatory requirements.
Regulatory Requirements