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Lean API Manufacturing

The environment in an API plant is very different from that in an automotive or electronics manufacturing company. Fair enough, it took us a while to learn this but now we know! Not only are shop floor processes different – so is the business environment. We concluded that a new customised approach was required in API companies.

A Lean Programme in an API plant is likely to involve some or all of the following:

  • Implementing PAT / in-line monitoring
  • Test rationalisation
  • Lean Clean-downs
  • Improvement of the Batch Record process
  • Implementation of Lean Laboratory techniques
  • Implementation of Lean Change Control
  • Implementation of Lean Root Cause Analysis
  • Implementation of Rapid Regulatory Response
  • Implementation of Lean Scale-Up
  • Elimination of corrective process steps like milling & sieving.

No other consulting company offering ‘Lean’ services has BSM’s knowledge of the pharmaceutical manufacturing environment. But why believe us – ask our clients!