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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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,
.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: Pharmaceutical Technology,
Click here