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.


The Wall Street Journal published an article informing all that pharmaceutical “manufacturing techniques lag behind those of potato-chip and laundry-soap makers.” The same article correlated the rise in recalls with quality problems and noted that despite fines in excess of US$500 million for manufacturing failures, acceptable levels of quality were still not being achieved...................a Question for you - - - -Many leading analytical balance manufacturers provide built-in "auto calibration" features in their balances. Are such auto-calibration procedures acceptable instead of external performance checks? If not, then what should the schedule for calibration be?.....................................Answer (1) The auto-calibration feature of a balance may not be relied upon to be FDA compliant to the extent of not requiring an external performance check (211.68). For a scale with a built-in auto-calibrator to be FDA compliant, we recommend that external performance checks be performed on a periodic basis, using a standard operating practice SOP. Less frequently as compared to a scale without this feature. The frequency of performance checks depends on the frequency of use of the scale and the criticality and tolerance of the process or analytical step. Note that all batches of a product manufactured between two successive verifications would be affected should the check of the auto-calibrator reveal a problem. Additionally, the calibration of an auto-calibrator should be periodically verified--a common frequency is once a year--using National Institute of Standards and Technology (NIST)-traceable standards or NIST-accredited standards in use in other countries.

Regulatory Expectations SOP's.




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