FDA Emergency Use Authorizations 101: COVID-19 Medical Devices
Everything You Need to Know About Emergency Use Authorizations for Medical Devices to Test and Diagnose COVID-19 In early February, the Secretary of HHS declared that the circumstances presented from...
FDA's Top 483 Observations for 2017: A Reflection of Industry's Compliance
At the beginning of each federal fiscal year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. I find that reviewing these metrics provides a valuable...
CPV versus APR, What’s the Difference?
As an outcome of the 2011 Food and Drug Administration Process Validation Guidance, there has been ever increasing interest in the pharmaceutical industry to establish formal Continued Process...
Quick Guide: Coordinating a Laboratory Move
Moving an operational Quality Control Laboratory is all about maintaining the support of production testing, ensuring physical integrity of the instrumentation being moved, and qualification of the...
Clinical Research Solutions
Outsourcing Facilities and GMP: The Validation Challenge
Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes,...
Understanding Statistical Intervals: Part 2 - Prediction Intervals
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
A Biotech Cleaning Validation Worst-Case Soil Selection
When conducting cleaning validation studies at large biologics or biotechnology facilities or perhaps even conducting a small cleaning validation study on a non-dedicated piece of equipment in the...
4 Key Parts to a Complete Product Complaint Handling Program
4 Key Parts to a Complete Product Complaint Handling ProgramAccording to 2012 FDA statistics, drug company’s Product Complaint handling systems (21 CFR 211.198) were cited in 142 Turbo EIR...
Do you need a starting point for a Serialization User Requirement Spec (URS)?
One of the challenges to starting any User Requirement Specification (URS) is to envision a structure which can allow for traceability as the project continues. The attached sample URS is a starting...