Thursday, February 26, 2015

Impurity ID: In Case of Contamination - BREAK GLASS


When contamination threatens your development project, BE PREPARED.

Black specks. Off-colors. Off-odors. Experiencing contaminant issues is a nightmare that can result in production shutdowns, rejection of batches or recalls of your product. Stay calm. Catch your breath and call 855-931-HELP (4357). ABC Laboratories will get the answers you need, quickly and with precision, so you can address the issue in record time.

Responsive. Rational. Results.


Every decision made during a contaminant crisis will impact how quickly a problem is solved. To get rapid, reliable results, a response must be specific and disciplined. At ABC, we conduct contaminant investigations in a rapid series of logical steps.


First, we quickly collect pertinent facts and apply years of troubleshooting experience to narrow the list of suspects...

Click here for the rest on this topic from ABC.

Tuesday, February 24, 2015

Noted Updates From ICH Q3D - Elemental Impurities (Step 2 to Step 4)


By Harley Everett Wilcox, MBA
www.abclabs.com

Implementation challenges persist with the ICH Q3D, elemental impurities, as the deadline for implementation is delayed and reported related to global implementation and industry feedback. IPQI suggests industry responses centered on Risk Assessment and amount of detail needed.  Global regulatory agencies, pharmacopeias, ICH and other stakeholder are involved and impacted by efforts to move away from USP <231>.

Some noted updates from ICH Q3D Step 2 to Step 4 include:

• Existing products have 36 months post step 4 publication for implementation.

• PDEs for iridium, osmium, rhodium, and ruthenium are based on palladium VS platinum.

 Additional detail prescribed to PDE assessment for other routes of administration beyond oral, parenteral, and inhalation—section 3.2.  Comment: Other routes may include rectal, topical, nasal, buccal, and transdermal. Section 3.2 suggests using available bioavailability data.

 Examples are provided for justification of higher levels than PDE using Modifying Factors.

 Parental Products section 3.4 now provides information for large parental dose and permissible PDEs.

 Selenium is now a class 2B vs 2A regarding element classification and excluded from risk assessment if not added to product.

 Class 4 has been renamed as “other elements.”

 Potential Sources of EIs Section: “known or suspected” container closure leachables changed to “Potential.” (See a recent webinar by ABC's own W. Rushing for more on this)

 ID of Potential EI’s –Section 5.3: Step 4 include more specific information for risk assessment base on route of administration i.e. oral and parenteral.

 The addition of Risk Assessment Summary includes a defined threshold based on PDE.

 Option 1, “permitted concentrations,” a change from MUST to SHOULD in regards following options 2a, 2b, or 3.

For more on this:

For more information from ABC (specifically on the implementation of new elemental impurities USP Chapters <232> and <233>), please visit this page on ABC Laboratories website which  has a link to download the working paper entitled "ABC Laboratories FormationsPaper on Implementation ofNew Elemental Impurities USPChapters <232> and <233>"

References:
PQRI.Org

S. Peterson, K. Wells, M. Silvey, L. Schrier, “ABC Laboratories Formations Paper on Implementation of New Elemental Impurities USP Chapters <232> and <233>.” ABC Laboratories, 2014.  www.abclabs.com.

ICH