The Pharmaceutical manufacturing industry is governed by regulations which are different in different countries. A regulatory pharmaceutical FDA audit is an imperative and apparently feared event. The fortune of a pharmaceutical manufacturing marketing license depends on its final result. According to the diverse market’s demand, many regulatory agencies periodically have to adhere the standard and regulations of the company. The pre-determined regulatory standards are a part of series of activities and procedures reviewed by FDA audit. In general, FDA audit in pharmaceutical industry is distinctly positioned to determine the existing capability of manufacturing processes to affirm safety and standardization. The whole process is outlines by an audit report and provides an abstract of the audit findings.
It is desirable in every progressive pharmaceutical manufacturing company that the audited report be induced to grow a positive and professional attitude. In this process of audit, the skills of each participant should be upgraded and enhanced. The goal for highest possible standards cannot be considered as being too ambitious. Constant and fierce competition demands the “Right First Time” approach. Safety and promise quality can be ensured only by accurate assessment and thus help to evolve best practices. FDA audit is acknowledged as a necessary evil by innumerable professional involved in pharmaceutical manufacturing units. It has to be faced with preparation and one has to adapt accordingly.
It has been highlighted that focused training in this field is a neglected area. Many individuals have been self-trained in this procedure only because they have been subjected to several audits in the past. The success rate is dependent on the experience they have gained gradually.
With the emerging and evolving market, quality and regulatory affairs professional should be trained and retrained for audits. The basic aim of audits in pharmaceutical manufacturing companies is to evolve and collectively prescribe an acceptable level of safety. The acceptance of the audits is subjected to procedures set by the foremost Regulatory Agencies, USFDA, MHRA and other European agencies.
Gradually the pharmaceutical industry has learnt the importance of FDA audits. The industry has accepted that an audit helps in standardizing practices and procedures of the company. It is further recommended that one should attend a workshop and participate in discussion of FDA audit.
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