A REVIEW ARTICLE ON SELF INSPECTION AND QUALITY AUDIT
Yogesh Waghmare* and Sonali Mahaparale
The goal of an audit is to express an opinion on the person, system, procedure and organisation, inspection have become a standard assessment tool deployed by regulatory authorities and standard bodies when monitoring external organisations. Producing and using spatial data as well as web services has reached the level of mass market, leading to new research challenges. Self inspection should be conducted in order to monitor the implementation and compliance with good manufacturing practices to process necessary corrective measure. The pharmaceutical auditing expertise includes writing and review of validation policies, ICH guidelines and Standard Operating Procedure (SOP) from design qualification to performance qualification. The audits are an effective means of evaluating compliance with the objective of the quality system. The various concepts are community, certification, accreditation, inspection, audit, quality assessment, quality control, quality assurance facing increasing risks of misusing given products. Personnel matters, premises, equipments, documentation, quality control, distribution of the medicinal products for dealing with complaints and recalls and self inspection. These guidelines provided by European Union (EU) gives a general guidance on conducting inspections. All self inspections should be recorded and also statements on the actions subsequently taken should also be recorded.
Keywords: The spatial data quality, auditing, certification, GMP components, regulatory aspect, accreditation and procedure of an audit.
[Full Text Article]