Everyone uses Excel Spreadsheets. Also in pharmaceutical companies, Excel Spreadsheets are used in different departments. But what are the EU GMP requirements for the templates. Read more in our GMP News about Excel Spreadsheets.
The US Food and Drug Administration has informed about a major reorganisation. The FDA has announced plans to introduce a new organisational structure which will become effective on January 2015. Read more about the FDA reorganisation
The deficiencies observed by FDA inspectors are written down in the so-called Form 483. Unlike Warning Letters, those aren't available online and have to be requested individually by post. Yet, FDA's evaluation of findings listed according to their frequency is pretty unknown. Read more here.
Which information is needed for compendial validation to include a method in the US American pharmacopeia USP/NF? In an article published in the Pharmacopeial Forum, the USP is proposing concrete requirements for compendial validation. More information can be found here.
The selection of starting materials for the manufacture of APIs frequently leads to delays in procedure for authorisation as the assessors from the regulatory authorities' side are not always happy with the justification of this selection. In a "Reflection Paper", the EMA tries to clarify essential elements on the topic. Read more here.
The US FDA has recently introduced a new service on their webpage. A new "inspection dashboard" provides information and analysis about the inspections which have been performed by the FDA in the previous years. Read more in our GMP News.
How should system suitability tests (SSTs) be structured for USP monographs? More about USP experts group's recommendations on the parameters and acceptance criteria for SSTs and the essential aspects of this new approach can be found in this News.
Currently there are no harmonised approaches to technical and regulatory considerations for the lifecycle management of pharmaceutical products. Therefore, ICH has just published a Final Concept Paper for a new ICH Q12 Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle. The proposed ICH Guideline is intended to fill this gap. Please find more information in our GMP News.
An SOP on the handling of Out of Trend Results is the objective of ECA Working Group on QC. Both trend analysis of statistical process control in the production as well as trend analysis in stability studies will be addressed. More information can be found here in the News.
Comments to the first draft on the revision of the current process validation guideline (for non-sterile processes) from April 2014 have now flowed into the second one. This is obvious at one point or another. Read more.
Compounding pharmacies in the US haven't been inspected by the FDA over the past years. For the first time, after a number of serious incidents which caused death, the FDA has tried to establish cGMP requirements for the manufacturers of outsourced drug compounding in an interim guidance for Industry. Read more details here.
EU GMP Inspectors from the competent authority in Romania identified several GMP deviations during a GMP inspection at a Chinese API manufacturer. As a consequence, a GMP Non-Compliance Report has been issued. Read more here about the GMP Non-Compliance Report.
The submission of documents relevant for authorisation to the Saudi Food and Drug Authority implies the consideration of certain requirements. A new Drug Master File Guidance provides information. Find out more.
The WHO has recently released the new version of its fundamental GMP Guide "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" together with the Technical Report 986. Read more.
The European Commission has published the new EU GMP Chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely and details additional requirements for recalling investigational medicinal products (IMPs). Read more.
This is a rather easy to answer question. It is answered along with other QP-related questions on Investigational Medicinal Products (IMPs) in a new set of Q&As published by the European QP Association. Read more.