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...
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...
Alarm Monitoring Program Selection
Let’s ask the questions; Does it need to be validated? What is involved in the process of selecting and installing a new temperature monitoring program? Does it need to be a full blown system, can I short cut the process? Can I install it or should I have the...
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...
Pest Control Records
A Pest Control program needs to look at not only rodent control, but also flying and crawling insects. The program needs to be adequate to ensure that these contaminations are minimized to the lowest level possible. Buildings used in the processing of a drug product are not maintained...
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...
Proper Equipment – Chamber Comparison
Can I use a food grade refrigerator as a stability chamber? In visit to a stability lab recently, I noted a labeled 5 C chamber that was a restaurant grade unit. In an effort to save dollars, the purchasing group found a refrigerator that would meet the needs of...
What Type of water do I need?
In the process of supplying water to a boiler or a humidification generator for a stability chamber, comes the question of which type of water to use. In today’s cost sensitive environments comes the challenge to justify the need to pretreat water that is going to be boiled away. ...
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...