Pharma Audit - Getting it Right the First Time

The Pharmaceutical industry is controlled by regulations which differ across borders. A Regulatory Audit, although inevitable, is an ostensibly feared event, as many a fate of a Manufacturing and/or marketing license depends on its outcome. In addition, the conformance to standards and regulations has to be reviewed periodically, by as many regulatory agencies as diverse markets demand. An audit is a series of activities and procedures to review the adherence to pre-determined regulations and standards. Audit in pharmaceutical industry is uniquely positioned to determine if the existing manufacturing processes are potent enough to promise safety and standardization. An audit report, produced as a consequence of this process, outlines the whole process and provides a summary of the audit findings.

In every progressive Pharma company, it is desirable that the auditees be induced to develop a positive and professional attitude to audit. The skills of each participant in this process of audit should be upgraded and enhanced. The goal for highest possible standards cannot be viewed as being too ambitious; constant and fierce competition demands the "Right First Time" Approach, each time. An accurate assessment can help evolve best practices, ensure safety and promise quality. The umpteen professionals involved in drug manufacturing should anticipate, accept and acknowledge that audit is a necessary evil. It has to be faced with preparation and one has to adapt and evolve to participate in one.

Even so, Focused Trainings in this aspect are a neglected area. Many have been self-trained in this procedure only because they have been subjected to several audits in the past, and have faced success in one or more.

However, Lady Luck doesn't favour the half-prepared everytime; the quest continues as many professionals today strive to know how to prepare for and participate in an audit; having borne the brunt of having an FDA 483 being issued against their organization, or having met with similar fate with European Agencies, inspite of having a USFDA clearance. The big question is how to train self, and participants from the entire organization for an audit. The enormous information and intelligence for this procedure is best acquired by interaction - with experts in the field or learning from common mistakes. In short, a workshop, a role-play, a group discussion, or any such activity which brings several in this domain together to share their experiences is desirable. Live examples and Case studies help understand how to "Get it right the very first time".

Evolving market dynamics and introduction of new procedures makes it necessary that manufacturing professionals in the pharmaceutical industry - Quality and Regulatory Affairs professionals - be trained and retrained for audits. It has become necessary to investigate and rectify the gap that exists in the perception and practicality of an audit. The basic aim of audits in pharmaceuticals is to help evolve and collectively prescribe an acceptable level of safety, and conformance to guidance and procedures set by the foremost Regulatory Agencies, USFDA, MHRA, other European Agencies, etc.

Applied uniformly across the industry, audit helps standardize practices and procedures. The pharmaceutical industry has progressively learnt not to deprecate audits. It is important that we all moot on this topic. The best way to prepare ourselves to contrive on success after every audit is to attend a workshop or participate in discussions. The upcoming conference (Prescription Pharma Support) on regulatory audit is a focused attempt to enunciate the importance, procedures, preparation and conduct of an audit. Anybody and everybody related to drugs, whether in operations, research or manufacturing, is bound to benefit. This conference is being conducted at Mumbai and Hyderabad in India. It is clearly an inviting opportunity to learn about the practical perspectives of audits.

Alline D'souza has expertise in pharmaceutical consulting, provides better advice in related to pharma market guidelines and pharmaceutical market research, visit http://www.pharmasupport.in to know about upcoming Pharma events, pharma jobs, pharma news, pharma market research.