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 are…
CAPA (Corrective and Preventive Action)
Definition of the term (“What is CAPA?”) A CAPA (Corrective and Preventive Action) is a measure within the quality management system (QMS) and is part of GMP compliant operations. This…
Complaint management
Definition of the term („What is a complaint?“) A complaint management includes all measures taken by a company to process customer complaints about the company’s performance. The emphasis lies on…
Corrective Actions
Definition of the term („What is a corrective action?“) The ISO 9000 describes a corrective action as a “measure to eliminate the cause of a detected fault or another undesirable…
Device Master Record (DMR)
Definition of the term („Was is a Device Master Record?“) A Device Master Record is a technical product file with compilation of records which includes the processes and specifications for…
Document Management System (DMS)
Definition of the term (“What is DMS?”)A document management system (DMS) can be understood as the management of electronic documents in a database. In the DACH region, it is also…
Enterprise Content Management System (ECM)
Definition of the term (“What is ECM?”) ECM is the abbreviation of Enterprise Content Management. This is the management of all data and information generated in an organization. ECM is…
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…
EU GMP Guideline Annex 11
Annex 11 of EU GMP guideline. It describes requirements for all kinds of computerized systems used as part of GMP-regulated activities.A computer-based system is a combination of software and hardware…
EU GMP Guidelines Chapter 4
The chapter 4 relates to the documentation. A good documentation is an essential part of the quality management. Moreover, it constitutes a key function for the production in compliance with…
EU GMP Guidelines Chapter 7
Chapter 7 “Outsourced Activities” of the EU GMP Guidelines deals with the responsibilities of the contractor and contracting entity in the case of outsourced activities. Basically, the chapter states that…
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,…
Functional specification
Definition of the term („What is a functional specification?“) A functional specification contains a contractor’s detailed description how he intends to solve the customers requirements. As the preceding instance, however,…
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…
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…
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 the…
IQ (Installation Qualification)
Definition of the term („What is an Installation Qualification?“) The installation qualification (IQ) documents the implementation of the requirements previously specified (e.g. in the design qualification) as part of the…
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…
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…
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…
Medical Device Regulation (MDR)
Medical Device Regulation (MDR) – Regulation 2017/745 (EU) on Medical DevicesThe German counterpart to the term “Medical Device Regulation” is “Medizinprodukteverordnung”. The European Union (EU) Regulation 2017/745 will become binding…
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…
Personnel File (digital)
Definition of the term („What is a Digital Personnel File?“) The digital personnel file is a software solution used to manage staff-related documents. It contains scanned documents as well as specifically created…
PQ (Performance Qualification)
Definition of the term („What is a Performance Qualification?“) The Performance Qualification (PQ) is an element of the qualification for machines and devices especially applied in GMP-compliant industrial manufacturing or…
Preventive Actions
Definition of the term („What are preventive actions?“) The ISO 9000 describes a preventive action as a “measure to eliminate the cause of a detected fault or another undesirable situation”.…
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…
Quality management handbook
Definition of the term („What is a quality management handbook?“) The quality management manual serves as an internal compilation and record of the quality management system of a company. It…
Quality Management Representative (QMR)
Definition of the term („What is a Quality Management Representative?“) A quality management representative (QMR) serves as a quality management consultant in a company. As the key person, he was…
Standard Operating Procedure (SOP)
Definition of the term (“What is an SOP?”) SOP (Standard Operating Procedure) is the English term for the German term “Standardarbeitsanweisung”. This is to be understood as a typical procedure…
User Requirement Specification (URS)
Definition of the term („What is an user requirement specification?“) A URS or User Requirement Specification contains a comprehensive description of the customer requirements with reference to the products and…
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…
WHO guidance on good data and record management practices
Another guideline with reference to implementing the legal requirements is the WHO Guideline on Good Practice for Data and Records Management by the World Health Organization. This guideline contains detailed…