STANDARD OPERATING PROCEDURE
Introduction to SOP's.
The SOP is used to lay out operations
consistently and repeatedly in the same repetitive manner. SOP’s must be available
for every task that is used in the manufacture or testing of a regulated
product. SOP’s ensure that all processes and procedures are consistently
replicated, so even when there are changes in personnel, organizations avoid
inconsistencies and do not run un-necessary safety risks.
Standard Operating Procedures or
SOPs are written step-by-step procedures that quality control (QC), quality
assurance (QA), and production units use in order to assure that the accuracy and
precision of the original product development is maintained in the
transformation from small trial and batch work to full scale production of the
product. SOP's are an essential part of the consistent replication of the tasks
that are used to produce a regulated product to a preapproved quality specification.
SOP's are active documents that are
routinely reviewed and amended as production processes are repaired, altered or
replaced. detail written instructions describing
specific steps to follow in all activities under defined conditions, they are
used to accomplish standardization when performing specific functions and used
to ensure approved methodologies are used wherever possible. Having defined all the appropriate procedures
and practices they are then used as audit standards to ensure that these define
methods are being meticulously followed and adhered to.
Regulatory Expectations SOP's.