The Role of Risk Analysis in Expanding Business Activities - Pharmaceutical Technology

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The Role of Risk Analysis in Expanding Business Activities
Risk management is essential in any successful outsourcing partnership. The author outlines the steps toward identifying, understanding, and controlling risk in key manufacturing areas.


Pharmaceutical Technology


Main risk areas

The following are examples of major risk areas:

  • Absence of a reference person or reduced professional competence. If the sponsor does not have a stable and competent reference person from the service provider tocollect and discuss the troubles, the company cannot obtain the interdisciplinary supplier evaluation that is often needed in this kind of partnership.
  • Inadequate equipment (e.g., inappropriate scale-up equipment)
  • Old equipment or bad maintenance
  • Absence of backup or contingency procedures
  • Difficulty establishing the transformation's costs (e.g., supplier ignorance of the goods and industrial formulation costs, resulting in price variance after the contract is signed)
  • Lack of structure or procedures (e.g., personnel experience, culture, and structure).

Check audit

The evaluation questionnaire alone is not enough. Several inspective checks should be conducted before considering the risk and defining the action plan. If the sponsor company wants to know in detail the status of the service provider's capability, more than one audit should be conducted, particularly in the main areas considered critical for business continuity. Focused checks in the critical areas help to better define the risk and the subsequent remediation plan.

It is also essential, when the action plan has been defined, that the sponsor company monitor the carrying out of the interventions contemplated in the action plan and that the partner be reliable and transparent when executing the plan.

The corrective actions defined in the remediation plan must be realized in a defined timeframe and as requested. Any problem during the advancement of this action plan could postpone the project start and have a negative, and sometimes disastrous, effect on business.

Maurizio Battistini is general manager of APP Pharmaceutical Partners Switzerland GmbH, Via Cadepiano, 24 CH-6917 Barbengo, Switzerland,
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