| The Pharmaceutical industry is controlled by | | | | organization, or having met with similar fate with |
| regulations which differ across borders. A Regulatory | | | | European Agencies, inspite of having a USFDA |
| Audit, although inevitable, is an ostensibly feared | | | | clearance. The big question is how to train self, and |
| event, as many a fate of a Manufacturing and/or | | | | participants from the entire organization for an audit. |
| marketing license depends on its outcome. In addition, | | | | The enormous information and intelligence for this |
| the conformance to standards and regulations has to | | | | procedure is best acquired by interaction - with |
| be reviewed periodically, by as many regulatory | | | | experts in the field or learning from common |
| agencies as diverse markets demand. An audit is a | | | | mistakes. In short, a workshop, a role-play, a group |
| series of activities and procedures to review the | | | | discussion, or any such activity which brings several in |
| adherence to pre-determined regulations and | | | | this domain together to share their experiences is |
| standards. Audit in pharmaceutical industry is uniquely | | | | desirable. Live examples and Case studies help |
| positioned to determine if the existing manufacturing | | | | understand how to "Get it right the very first time". |
| processes are potent enough to promise safety and | | | | Evolving market dynamics and introduction of new |
| standardization. An audit report, produced as a | | | | procedures makes it necessary that manufacturing |
| consequence of this process, outlines the whole | | | | professionals in the pharmaceutical industry - Quality |
| process and provides a summary of the audit | | | | and Regulatory Affairs professionals - be trained and |
| findings. | | | | retrained for audits. It has become necessary to |
| In every progressive Pharma company, it is desirable | | | | investigate and rectify the gap that exists in the |
| that the auditees be induced to develop a positive | | | | perception and practicality of an audit. The basic aim |
| and professional attitude to audit. The skills of each | | | | of audits in pharmaceuticals is to help evolve and |
| participant in this process of audit should be upgraded | | | | collectively prescribe an acceptable level of safety, |
| and enhanced. The goal for highest possible standards | | | | and conformance to guidance and procedures set by |
| cannot be viewed as being too ambitious; constant | | | | the foremost Regulatory Agencies, USFDA, MHRA, |
| and fierce competition demands the "Right First | | | | other European Agencies, etc. |
| Time" Approach, each time. An accurate assessment | | | | Applied uniformly across the industry, audit helps |
| can help evolve best practices, ensure safety and | | | | standardize practices and procedures. The |
| promise quality. The umpteen professionals involved | | | | pharmaceutical industry has progressively learnt not |
| in drug manufacturing should anticipate, accept and | | | | to deprecate audits. It is important that we all moot |
| acknowledge that audit is a necessary evil. It has to | | | | on this topic. The best way to prepare ourselves to |
| be faced with preparation and one has to adapt and | | | | contrive on success after every audit is to attend a |
| evolve to participate in one. | | | | workshop or participate in discussions. The upcoming |
| Even so, Focused Trainings in this aspect are a | | | | conference (Prescription Pharma Support) on |
| neglected area. Many have been self-trained in this | | | | regulatory audit is a focused attempt to enunciate |
| procedure only because they have been subjected | | | | the importance, procedures, preparation and conduct |
| to several audits in the past, and have faced success | | | | of an audit. Anybody and everybody related to |
| in one or more. | | | | drugs, whether in operations, research or |
| However, Lady Luck doesn't favour the half-prepared | | | | manufacturing, is bound to benefit. This conference is |
| everytime; the quest continues as many | | | | being conducted at Mumbai and Hyderabad in India. It |
| professionals today strive to know how to prepare | | | | is clearly an inviting opportunity to learn about the |
| for and participate in an audit; having borne the brunt | | | | practical perspectives of audits. |
| of having an FDA 483 being issued against their | | | | |