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Quality & Compliance
Continued Cleaning Effectiveness: What Are You Doing? - Part II
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...
Quality & Compliance
Outsourcing Facilities and GMP: The Quality Systems 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,...
Continued Cleaning Effectiveness: What Are You Doing?
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...
Regulatory Sciences
FDA Prepares for GDUFA Commitments with Controlled Correspondence Guidance
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the rules and specific protocol for submitting controlled correspondence to the Office of Generic Drugs (OGD) in a draft guidance published on August 27,...
Quality & Compliance
Environmental Monitoring: The Top 3 Points to Consider
When a biopharmaceutical company builds new or renovates existing manufacturing space, the last consideration before turning the production key is the environmental monitoring of the same. This short...
Regulatory Sciences
FDA Aims to Standardize REMS Programs
On September 23, FDA released a report regarding “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)”. This fulfills FDA’s PDUFA commitment to issue a report of findings...
Quality & Compliance
Using Propagation of Error to Determine Validation Acceptance Criteria for In-Process Measurements
Many times in validation I am confronted with the problem of how to set acceptance criteria for critical process measurements. This is particularly true of in process measurements made during...
Sneak Preview: What Will the Quality Metrics Initiative Look Like?
I had lunch in a restaurant the other day. During my meal, I noticed that there weren't many other customers. I didn't give it much thought until I walked out and read the restaurant's hygiene grade...
Is social media the next monitoring emphasis for the OIG?
In June 2014, the FDA issued two draft social media guidance documents that may not clearly answer all of the questions that the drug and device industries have about how to use social media to...
FDA Updates Informed Consent Guidance
FDA recently updated its informed consent guidance in the form of an Information Sheet. The new document reflects the Agency’s current thinking on the informed consent process utilized in...
Regulatory Sciences
New 510(k) Guidance Bans 'Split Predicates'
Medical device manufacturers may need to re-think their approach to demonstrating substantial equivalence (SE) in the 510(k) notification process, due to the FDA’s recent finalization of the guidance...
Quality & Compliance
Are you moaning about cleaning?
From time to time in this industry, you will hear someone bemoaning the fact that they have to do a cleaning validation. If this happens to be you, have no fear and remember the following five points...
Quality & Compliance
The Difference Between Quality and Compliance, Part II
In our previous blog, "The Difference between Quality and Compliance", I mentioned that there are recent initiatives underfoot that FDA hopes will create FDA-industry partnerships, increase...
Quality & Compliance
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,...
Quality & Compliance
The Difference Between Quality and Compliance
In case you haven’t noticed, FDA is tired of being the “bad guy”. While they do not back-off of their responsibility to enforce the applicable Code of Federal Regulations for a millisecond, their...
