ARTICLES BY GREG WEILERSBACHER

• Equipment Change Control For GMP Production Facilities — Proving It All Works

  7/10/2019

  The first article in this two-part series outlined the six primary stages of equipment change control and discussed the first two stages: (1) determining the equipment utility/IT requirements and (2) pre-installation assessment, utility evaluation, and remediation. This article describes the final four stages of this process: (3) evaluating the impact of new equipment installation on previously validated utilities, (4) executing validations for new equipment, (5) review of equipment turn-over packages and validation reports, and (6) performing change control effectiveness checks.

• Equipment Change Control For GMP Production Facilities — How To Get Started

  6/5/2019

  While many may conceptually understand change control for equipment and facilities, most lack the knowledge to apply this control to highly sophisticated equipment and the utilities to which they connect.

• Will CDMOs Commit To Fully Transparent Audits?

  3/19/2019

  The first two articles in this series discussed the physical elements of facility design that sponsors look for in their CDMOs and sponsor requirements for dedicating equipment to GMP operations, equipment redundancy, and immediate disclosure of equipment and facility issues. This article presents solutions to improve transparency during sponsor audits of CDMOs.

• How Much Do You Really Know About Your CDMO’s Equipment (And How Much Should You)?

  2/19/2019

  The first article in this series discussed the physical elements of facility design that sponsors look for in contract development and manufacturing organizations’ (CDMOs) manufacturing facilities. 

• CDMO Facility Design —What Pharma Companies Should Be Looking For

  1/24/2019

  This series of articles address manufacturing facility and laboratory design elements that enhance the sponsor’s experience, protect its product against cross contamination, and meet regulatory requirements.

• Assessing The Impact Of New Equipment On Your CDMO’s GMP Operations

  12/18/2018

  To a drug sponsor, a CDMO’s new equipment could mean production may be able to start sooner than expected, or it might allow them to continue working with a CDMO rather than switching to another.

• Top 5 Ways To Get The Most Out Of A Supplier Audit

  11/27/2018

  Your outsourcing may come in the form of manufacturing of a sterile injectable, tablets, or topical dosage form or it may be GMP product release and stability testing. The product may need to be stored under controlled temperature and humidity conditions and then distributed to locations around the globe. The suppliers you choose are of paramount importance to your company’s success.