regulatory,

Mobile scanning and other technologies in the labeling and package leaflet of centrally authorized medicinal products

With the availability of new communication technologies it has become apparent that patients / users / health care professionals can benefit from information provided by electronic formats. In this context, there are two types of rapid response (QR) codes and two-dimensional (2D) barcodes, or Near-field Communication (NFC), among others, as an additional way of providing information to patients and health care professionals.

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regulatory,

Guideline on the quality of water for pharmaceutical use

Water is one of the major commodities used by the pharmaceutical industry. It may be present as an excipient or used for reconstitution of products, during synthesis, during production of the finished product or as a cleaning agent for rinsing vessels, equipment, primary packaging materials etc.

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regulatory,

Data Integrity and Compliance With Drug CGMP Q & A

21, 210, 211, 212, 501, 2, XNUMX, XNUMX, XNUMX, XNUMX, XNUMX and XNUMX. Unless otherwise noted, the term CGMP in this guidance refers to CGMPs for drugs (including biologics). FDA's authority for CGMP comes from section XNUMX (a) (XNUMX) (B) of the Federal Food, Drug, and Cosmetic Act (FD & C Act).

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regulatory,

Medical products - quality, safety and innovation

This document sets out frequently-asked questions and answers concerning the implementation of the rules on the safety of medicinal products for human use.
These rules are enshrined in Articles 47a, 54 (o) and 54a of 2001 / 83 / EC Directive, and Commission Delegated Regulation (EU) 2016 / 1612.

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Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use Guidance for Industry
regulatory,

Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use Guidance for Industry

This guidance is provided by the Food and Drug Administration (FDA). The recommendations are made in accordance with the provisions of the Consumer Code of Drugs and Regulations.3 for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient -use containers.

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Safety features for medicinal products - 11 Version
regulatory,

Safety features for medicinal products - 11 Version

This document sets out frequently-asked questions and answers concerning the implementation of the rules on the safety of medicinal products for human use. These rules are enshrined in Articles 47a, 54 (o) and 54a of 2001 / 83 / EC Directive, and Commission Delegated Regulation (EU) 2016 / 1612.

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Good Distribution Practices (GDP) - FAQs
regulatory,

Good Distribution Practices (GDP) - FAQs

Is it necessary for a manufacturer of pharmaceuticals to comply with the Good Distribution Practices (GDP) or is it the task of wholesalers and distribution companies? And other questions are addressed in this FAQ from the Good Distribution Pratice Group

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