Article archive

Frequently asked GMP question: How should active substance auditors be qualified?

17/10/2013 22:26
From time to time we receive "GMP questions" from ECA Members. On a regular basis we will provide answers by using the official statements of regulatory authorities. The follwoing question has been answered by EMA in a Q&A section: How should active substance auditors be qualified? Auditors...

Qualification, Requalification - frequent Obscurities

17/10/2013 22:25
  The terms qualification, requalification and monitoring are often mixed up, especially if the somewhat different language from ISO standards is used in the GMP environment. This can lead to misunderstandings that may result in problems. Read more.  

Changes in the EDQM CEP Database

17/10/2013 22:24
The EDQM maintains a database that contains the relevant information about the issued Certificates of Suitability (CEP). The publicly available version allows you to search for a variety of information: Name of the certified substance Monograph number Owner of the CEP CEP number Date of issue...

EFPIA selects Microsoft Cloud Platform for the European Verification System against counterfeit Medicines

17/10/2013 22:21
The "European Stakeholder Model" (ESM) proposed by the European Federation of Pharmaceutical Industries and Associations (EFPIA) is based on the concept that any medicinal product must be checked with its delivery (point of dispensing verification). The technical implementation is accomplished via...

FDA publishes Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility

17/10/2013 22:19
 In March, the FDA published a Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility. This document is supposed to assist blood establishments in developing a blood establishment computer system validation program, consistent with recognized principles of...

EMA Guideline on the use of bovine serum in the manufacture of human biological medicinal products

17/10/2013 22:19
On 1 December 2013, the adopted Guideline on the use of bovine serum in the manufacture of human biological medicinal products will come into effect. This document, adopted on 30 May 2013 by the Committee for Medicinal Products for Human Use, replaces the Note for Guidance on the use of bovine...

FDA publishes current list of Drug Master Files (Type II)

17/10/2013 22:18
All holders of a Drug Master File (DMF) for the US market are required to pay a DMF fee when first authorizing the reference of their DMF in a generic application. In addition, Type II API DMFs must undergo an FDA initial completeness assessment. This assessment is described in the FDA Draft...

New FDA Requirement on the Handling of INDs

17/10/2013 22:16
FDA has put into effect the internal Manual of Policies and Procedures MAPP 6030.9 on good review practices for applications submitted for new drugs (IND = investigational new drug applications) in April 2013. This document is supposed to provide a consistent approach to the handling of submissions...

FDA Scientists link transfused UVB irradiated platelets with acute lung injury

17/10/2013 22:11
With a mouse model, scienists demonstrated a link between transfused UVB irradiated platelets and acute lung injury. The scientists at the U.S. Food and Drug Administration (FDA) reported that studies performed in animals provide a proof of a concept that transfused UV-light damaged PLTs can...

New FDA Requirements on Labelling and Container Labels

17/10/2013 22:10
In April 2013, the FDA released the Guidance for Industry "Safety Considerations for Container Labels and Carton Labelling Design to Minimize Medication Errors" as a draft. The purpose of this document is to provide a range of principles and recommendations for ensuring the correct and safe use of...
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