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Quality & Compliance
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...
Regulatory Sciences
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...
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...
Introduction A key prerequisite activity for any successful process validation is process characterization. Process characterization involves varying process inputs such as raw material properties,...
Quality & Compliance
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
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,...
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
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the rules and specific protocol for submitting controlled correspondence to the Office of Generic Drugs (OGD) in a draft guidance published on August 27,...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
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
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
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...
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...
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 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
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...
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...
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...
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...