[Stability Testing related News – vol.21]

◆  Identification of Medicinal Products Standards will apply in six Months (09-Dec-15 ECA)

Over the last couple of years the European Health Authorities in conjunction with the International Standards Organization (ISO) have been developing a set of global data standards referred to as Identification of Medicinal Products (IDMP).

The Identification of Medicinal Products (IDMP) standards were developed in response to a worldwide demand for internally harmonized specifications for medicinal products. The EU is the first to implement these standards, and the other ICH regions will follow. The pharma sector must comply with IDMP standards in the EU region starting July 2016. Following the EU, the other ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) countries will then begin their own adoption processes to ensure global compliance.

Once the IDMP standards are implemented globally, detailed information about all medicinal products worldwide will, for the first time, be available in a consistent format. This provides regulators with the means of easily comparing product data across regions and with different manufacturers and marketing authorisation holders. This increased transparency will drive numerous patient safety initiatives. It also paves the way for the future roll-out of patient-centric initiatives such as ‘e-prescriptions’.

Adopting the IDMP standard should not only help to achieve regulatory compliance but wants also improve internal business process efficiencies, as well as increase effectiveness between business functions and with external partners, truly enabling a task to value strategy.

◆  FDA gives Advice on the Use of Control Charts (07-Jan-16 ECA)

FDA has been observing more and more deficiencies in the area of statistics with regard to process validation. One of the “statistical methods” – also stated in FDA’s Process Validation Guidance – is the use of control charts in the context of a statistical process control (SPC). A SPC can be a valuable resource, particularly in stage 3 of the process validation lifecycle (continued/ongoing process verification).

During an event with the Product Quality Research Institute (PQRI), Dr Daniel Peng from CDER’s Office of Processes and Facilities (OPF) presented his views on the use of SPC under the heading “Using Control Charts to Evaluate Process Variability”. He began with the history of control charts and their fields of application. He furthermore considered the most important rules to create and manage control charts, including types of control charts, sampling and evaluation rules according to the Western Electric Rules.

He concluded his presentation with examples of control charts for evaluating intra and inter-batch variabilities and site performance monitoring.   
 
The slides of the presentation “Using Control Charts to Evaluate Process Variability” are very easy to read and available for free. 

◆  Revised USP Chapter <670> Containers – Auxiliary Packaging Components (07-Jan-16 ECA)

A revised version of USP general chapter <670> Auxiliary Packaging Components was published for comments in Pharmacopoeial Forum 42(1), January-February 2016.

The previously revised chapter <670> was published in Pharmacopoeial Forum 40(6), November-December 2014, and will become official on May 1, 2016 (USP 39-NF 34). This revision included the introduction of compendial standards for packaging desiccants. Common types of commercial desiccants are, for example, bentonite, calcium chloride, calcium oxide, molecular sieves, and silica gel. For these materials specific tests and assays are described in the general chapter.

Other desiccants are subject to appropriate testing to ensure suitability for the intended application. The desiccants may be incorporated directly into the wall or cap of packaging containers or bound by a carrier material.

On the basis of a comment received, in Pharmacopoeial Forum 42(1) it is proposed to cross reference general chapter Spectrophotometric Identification Tests <197>, to add the needed flexibility to the Infrared Spectroscopy section of paragraph Pharmaceutical Coil in chapter <670>. Therefore, the ATR technique can be used as alternative method.

Deadline for comments is March 31, 2016.

◆  ISO 14644 – Part 1: The Long-Awaited Final Version on Cleanroom Classification (27-Jan-16 ECA)

Part 1 of ISO 14644 entitled “Classification of air cleanliness by particle concentration” is one of the most  important norms in the GMP environment as it is the only technical norm which is directly referred to in an official GMP guideline document: the currently applicable Annex 1 of the EU GMP Guide. This norm is decisive and has to be used for the classification of cleanrooms used for GMP production. It contains the tables of cleanroom classes and their respective maximum of permitted number of particles as well as instructions on how to perform particle measuring.

The revision of the norm had already started in 2007. Many drafts have been published, e.g. in 2011, 2012, 2014 and 2015 but not a single one of them could achieve the final status. All the time, the version of 1999 has been applicable.

Now, since the end of 2015, the final version in English of the ISO 14644-1 is available from the publisher Beuth.

Substantially, the new version  includes the following changes:

• The number of measuring points is no longer calculated as the square root of the surface but given in a table.
• 5 µm particles for ISO 5 has been dropped from the limit value table.
• No more statistical UCL calculation: there is no need to perform an observation of all measuring points in the room any longer. Each single measuring point is considered individually and has to meet the limit value.
• The tubing length to the particle counter should be less than 1 m.
• The classification number, the sample volumes/ measuring period as well as the cancellation criterion remain unchanged compared to the version of 1999.