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Clinical Research Solutions
The diagram below depicts an example CSV lifecycle alignment with ASTM E2500 and GAMP. Building onto a previous post, Lean CSV - How to Reduce Waste and Increase Value, today's blog focuses on...
Clinical Research Solutions
There are thousands of drug manufacturers that have a number of ongoing projects within Operations. Often times, these companies seek experienced consultants to assist/guide them to project...
Clinical Research Solutions
ASTM E2500 – Risk-based testing has been in play for several years now. By design, there is a significant opportunity to avoid many lifecycle costs without creating an adverse impact to quality or...
Clinical Research Solutions
Cleaning Validation and GMP reviews of those protocols are challenging. They become even more challenging at a Contract Manufacturing Organization (CMO) where compliance assessments to in-house...
Clinical Research Solutions
Introduction A key prerequisite activity for any successful process validation is process characterization. Process characterization involves varying process inputs such as raw material properties,...
Clinical Research Solutions
My last blog focused on the industry trends concerning cleaning validation verification. Through a quick poll we found that out of twenty-three respondents, approximately fifty (50) percent are doing...
Clinical Research Solutions
Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcingfacility, a person under the supervision of a licensed pharmacist, combines, mixes, or...
Clinical Research Solutions
Recently I was asked by a client whether they should continue to do Re-Qualifications or change to Continued Process Verification on their qualified cleaning circuits. To answer this, the factors to...
Clinical Research Solutions
With the implementation of GDUFA, FDA defined the rules and specific protocol for submitting controlled correspondence to the Office of Generic Drugs (OGD) in a draft guidance published on August 27,...
Clinical Research Solutions
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...
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
Clinical Research Solutions
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
Regulatory Sciences
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...