Reviewing 'Keys to Quality'

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On May 30th 2019, OBIO hosted a talent development workshop featuring Martin Musiol (RA/QA Manager, IPD Inc.) who presented “The Keys to Quality: Introduction to Good Manufacturing Practices, Quality Management Systems, and Working in Regulated Environments.”

The workshop began with an overview of Good Manufacturing Practices (GMPs).

Martin advised that GMPs for biopharma and device manufacturing are all based on the same 3 key principles, regardless of jurisdiction:

  • Manufacturing process must be clearly defined and controlled;

  • All critical processes are validated to ensure consistency and compliance with specifications;

  • Any proposed changes to manufacturing processes must be evaluated for impact on finished product, and such process are to be revalidated as needed.

Martin then talked about Quality Management Systems (QMS) with a focus on key QMS processes, including: document and change control, management review, standard operating procedures SOPs and corrective & preventive actions (CAPA). A significant portion of the presentation was focussed on SOPs and CAPAs, including different methods for conducting a root-cause analysis, as anyone involved in manufacturing will likely be involved in writing and reviewing these documents.

Martin noted that SOPs:

  • must be clear and concise

  • must generate evidence of compliance

  • should only contain information relevant to achieving the previous two points

  • should be written from the end-users perspective so seek their input

  • follow a simple step-by-step format

  • not try to combine multiple tasks into one SOP

If you missed this valuable OBIO workshop, the recorded webinar of the presentation is now available on the OBIO Member Portal. (If you are not yet an OBIO Member, please click here to sign up.)

The online webinar is accompanied by downloadable templates for SOPs, CAPAs in addition to information on Costs, Timelines, and Strategy for developing a QMS.