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As a biopharmaceutical company matures and new products are added to its portfolio, expansion of its facilities, systems and Quality Control is a natural outcome. The growth in the Quality Control...
Quality & Compliance
In my previous blog I re-visited key GAMP® 5 concepts as they relate to establishing a compliant system validation methodology. My next few blogs will focus on each of these concepts in more detail....
Regulatory Sciences
We note with interest FDA’s recently released Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (April 2014). The guidance summarizes the...
Earlier this year, the Officer of Inspector General (OIG) put smaller life sciences companies on notice that they should put in place a risk assessment process as part of their corporate compliance...
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,...
Quality & Compliance
As the pharmaceutical supply chain evolves, at some point product/technology transfers will become part of the improvement process. When transferring production from site to site, an array of complex...
Quality & Compliance
Over the past several years, pharmaceutical company Corporate Integrity Agreements (CIAs) have routinely required needs assessments in connection with the engagement of healthcare professionals...
Quality & Compliance
It is amazing to me that more C-Level Executives do not perceive their Quality Systems as a powerful vehicle to reduce costs, improve productivity, and benefit their bottom line. Rather than embrace...
Regulatory Sciences
Following extensive marketing of Lovenox® (enoxaparin sodium), a low-molecular weight heparin, a number of biosimilar versions of enoxaparin and one ANDA-approved formulation (enoxaparin sodium,...
Quality & Compliance
Next week I’ll be in San Francisco conducting an ISPE training class on Risk Based Approach to GxP Process Control Systems. Attendees will include employees from a variety of regulated life cycle...
Quality & Compliance
Today we have the next phase of the Nine Gate Transfer Process: Gate 8 Process Validation. To review the previous steps before continuing, examine Gates 1-7 here: Gate 1: Assessment Gate 2:...
How robust are your cleaning validation measures? Could your storage procedures withstand the impacts of a fire within your facility, or would such a disaster set back your production time...
Unverified Design – An Example For those of us who travel routinely, one of the most sought-after treasures in the typical airport terminal is an electrical outlet. With our dependency on mobile...
Quality & Compliance
At the recent Pharmaceutical Compliance Congress (PCC), Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania stated that one of the key questions that a company should ask about its...
Regulatory Sciences
For most drugs, the process of developing and obtaining FDA approval of a generic version is simple and well-defined: sponsors must only prove that their product is pharmaceutically equivalent and...
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...
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...
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...
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...
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...
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....