Peter Calcott

A native of the UK, Dr. Calcott has a career spanning 4 decades and has worked for Pharma companies such as SmithKline Beecham, Monsanto and Bayer as well as biotechnology companies such as Immunex, Chiron and PDL. He has held positions in R&D, Manufacturing, QA & QC, Process Development, Corporate Compliance, Business Development, and Government Affairs. He has worked on biologics (vaccines, recombinant proteins, monoclonal antibodies, blood products), drugs and generics from early development to commercial. Prior to entering industry he taught at university. He is a member of the Board for BayBio and is chairman of the RAC committee of BIO. Dr. Calcott has a BS from University of East Anglia and D.Phil from University of Sussex in the UK. While in Academia he was a consultant to University, government and industry. He has published over 90 research articles, reviews and books.

Posts by Peter Calcott:

• What does a Quality or technical agreement have to contain?

  19 Sep 2011 in Contract Manufacturing & GMP & Quality Agreements & Webinars

  I was on a panel discussion on Contract Manufacturing in Berlin this last week and the topic of Quality or Technical Agreements produced a vigorous debate. While everybody agreed that the requirements for the documents are codified in the EU by regulations, the FDA does not directly require them by law. However, as most know, if you […]

• So when do you start Quality by Design?

  12 Sep 2011 in Clinical Manufacturing & Commercial Manufacturing & GMP & Quality by Design

  After participating on a panel discussion at an IBC conference on Quality by Design (QbD) and the new Process Validation guidance issued earlier this year by FDA, I was approached by a process development scientist who asked my advise on the value of implementing  QbD in their company. He explained that his company was extremely small and did […]

• Compendial Methods Need To Be Qualified

  12 Sep 2011 in Commercial Manufacturing & Compendial Methods & GMP & Warning Letter

  During a recent class I taught at University of California, Berkeley in their Quality and Compliance postgraduate certificate program, a question came up from one of the attendees that mirrored very closely observations I have made in audits over the years. And that question was “do we have to validate compendial methods we use in testing our […]

• GMP In Clinical and Commercial Manufacturing

  19 Aug 2011 in Clinical Manufacturing & Commercial Manufacturing & GMP

  A few years ago, the FDA issued a guidance to the effect that for Phase 1 clinical manufacturing, GMP’s were not required. However, patient safety had to be assured etc. A while later the guidance was retracted to indicate that GMP would, after all, be required. And that is how it was left. For both […]

• Vendor Qualification – What Can Go Wrong

  12 Aug 2011 in Vendor Qualification & Warning Letter

  As Calcott Consulting spreads its wings and extends its reach into the Pharmaceutical and Biotech industry, it is time to start a blog. This is the first (and hopefully not the last post).The topic for today is VENDOR QUALIFICATION. I routinely review FDA warning letters every month or so to see how the industry is […]