Thursday, 14 January 2016

Fwd: Attitude towards GMP

Subject: Attitude towards GMP

cGMP training programs are usually boring and technical because most people think they know all about GMP. It is not the content of GMP that is critical but the attitude of people who are expected to adopt GMP. Many GMP failures have occurred not because people were ignorant but because people did not have the right attitude. Ironically, the attitude cuts across the vertical hierarchical structure of an organization. 

Also, a level of complacency develops when an organization has gone through a few successful FDA and MHRA GMP audits. This complacency percolates down the line because a cross-section of employees, who know the flaws in their organizations, start believing that we can 'fool' all the auditors all the time.

A unique two-days workshop blending principles governing life and GMP was initiated on 30th December 2015 by Prescription Pharma Support, Mumbai and Sri Krishna Pharmaceuticals, Hyderabad.

Top officials from 4 manufacturing units, about 40 in number, participated. The departments represented were Manufacturing, Technical ServicesQC, QA, IT, HR, R&D, Warehouse, Engineering and Corporate Managers participated.

Laws of living and their relevance in professional life was the highlight of day 1. The backdrop was Lord Buddha's noble 8-fold path. This was organized in a meeting setup.

The second day was rearranged as clusters with teams formed from the members of the 4 units applying cross-functional and cross-locational mix.

Live case studies were discussed relating the noble 8-fold path to understanding deviations, investigations, root cause analysis,   writing SOPs and communication skills.

The unique experiment was well received and the participants and corporate managers expressed delight at the outcome of two fruitful days.

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