What is risk? “The combination of the probability of occurrence of harm and the severity of that harm.” Guidance for Industry, FDA. What is Quality Risk Management (QRM)? Definition: In Pharmaceutical industry, “QRM is a systematic process for the assessment, control, communication and review of risks to the quality...
Articles by Atsuko Keasling
Stability Testing related News – Vol.7
◆ EU GMP Non-Compliance Report might lead to FDA Import Stop in future (11-Apr-17 ECA) The new MRA Agreement between the EU and the USA on the mutual recognition of GMP inspections is being discussed in depth. One shouldn’t conclude though that the inspection pressure would decrease now because...
Stability Testing related News – Vol.6
◆ What are the current GMP Inspection Initiatives? (08-Feb-17 ECA) The International Coalition of Medicines Regulatory Authorities (ICMRA) has published a very interesting overview about the current global GMP inspection initiatives by the competent authorities. It also shows the various initiatives between the EU and the US Food and...
Stability Testing related News – Vol.5
◆ Selection and justification of starting materials: new Questions and Answers to ICH Q11 published (07-Dec-16 ECA) The ICH Q11 Guideline describes approaches to developing and understanding the manufacturing process of drug substances. It was finalised in May 2012 and since then the pharmaceutical industry and the drug substance...
Stability Testing related News – Vol.4
◆ GDUFA: FDA’s new Guidance on Self-Identification of Generic Drug Manufacturers (05-Oct-16 ECA) The GDUFA (Generic Drug User Fee Amendments) is a legislative package which came into force in 2012 and entitles the US-American FDA to collect fees from generic drug manufacturers, who strive for a marketing authorisation for...
Stability Testing related News – Vol.3
◆ Data Integrity – two new documents from PIC/S and EMA (11-Aug-16 ECA) In the last two years, national competent authorities from all over the world have focused more and more on Data Integrity. Many draft guidances from different authorities were published in 2016. In April 2016, the American...
BIOCOM CRO Best Practice Series
We are very pleased and honored to announce that we will be giving a presentation titled “Asset Management Best Practices” at BIOCOM CRO Event on September 22. http://biocomcro.org/events/ Our speaker and stability storage process consultant, Gary Ostermiller is an experienced stability professional with extensive experience in pharmaceutical stability...
Stability Testing related News – Vol.2
◆ Revision of the general Chapter on Pharmaceutical Water in the US Pharmacopoeia (15-Jun-16 ECA) The 2nd supplement of USP39 NF34 comprises the revised version of the chapter on pharmaceutical water of the US Pharmacopoeia <1231> Water for pharmaceutical purposes. The first draft version had already been published in...
Stability Testing related News Vol.1
◆ New Details on the Revision of USP Chapter 1 (13-Apr-16 ECA) USP’s Chapter <1> “Injections and Implanted Drug Products (Parenterals)-Product Quality Tests’ has been revised again. New information is now available. The USP published these details on 25 March. The revised version now contains a table...
BIOCOM’s LifeLines summer 2016
Have you seen BIOCOM’s LifeLines summer issue? See page 21. We are there! You can also get LifeLines at 2016 Bio International Convention.