Developing SOP Skills:
This article brings about the fundamentals of writing / imposing industrial Standard Operating procedures (SOP’s); which ensures internal compliance requirements / external regulatory requirements. If you are a pharma / bio pharmaceutical manufacturer, this is no surprise with Food and Drug Administration because “establish” means to define, to document, to implement and to comply with regulatory requirements.
There are unnumerable instances of regulatory authorities and warning letters regarding compliance procedures that take place within bio pharmaceutical facilities throughout the global landscape. For Example: If companies do not have any quality audit process in place to ensure that the quality system is in compliance with the established quality management requirements and to influence the effectivity of the quality process. If as on date no audits that have been taken place, facility take a commonsense approach and look at what is mandatory to exert control of operations, and then add up in the extra requirements to assure compliance, companies will have a well-maintained / documented procedures that can be insured and maintained with a minimal paperwork.
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