Case Study 3 - Compliance and GMP Training: Pharmaceutical Products Manufacturer

The Situation:
Prior to starting work with us our client had undergone an audit by the TGA (the Australian equivalent of the FDA) during which several compliance/GMP issues were uncovered. The TGA advised our client their GMP compliance was substandard and they were given six months in which to improve it. Failure of two consecutive GMP audits would result in the closure of the plant.

1. To improve the standard of compliance and GMP knowledge amongst all employees with access to production areas (operations, maintenance and support personnel) to a level superior to that required for them to pass future internal and external audits.
   
2. To identify and correct any attitudes or beliefs that might inhibit the use of correct compliance and GMP behaviors.
   
3. To provide a rigorous system for assessing compliance and GMP knowledge.

1. Reattach the label to the bin and package the product, or;
2. Contact the team leader, fill out a product exception sheet, which is then approved by the team leader and QC and then proceed with the packaging.

The correct action is 2, but as you can well imagine some operators might be tempted to simply reattach the label and continue packaging. The dilemma the operator faces and the importance of motivation in determining their response are clearly communicated in the balance of consequences diagram below. Keep in mind that motivators that are personal, immediate and a certainty are typically stronger than motivators that are organizational, delayed and only a possibility.

Consequence of Reattaching Label		Consequences of following GMP Guidelines
(+)	(-)	(+)	(-)
Good production figures for the shift Personnel not idle. Lower costs/better profits for company Less work, no hassle explaining problem	Might be disciplined or even lose their job if caught or reported Severe impact on customers if he/she is wrong Severe impact on company if he/she is wrong	Satisfaction at having done the right thing Possible congratulations from the team leader and QC	Production delays Personnel idle. Higher costs/lower profits Extra work, hassle of explaining problem, filling out paperwork and collecting approvals Possible negative reinforcement from team leader

To assist our client Talsico® designed a Learning Strategy that focused on building compliance and GMP knowledge and strengthening those attitudes and beliefs that would support good compliance and GMP. Further emphasis was placed on developing attitudes and strategies that would encourage people to support each other in making the right decisions.