-The Standard Operating ProceduresF (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 procedures they are then used as audit standards to ensure that these define methods are being meticulously followed and adhered to.
It can be deduced from what is written above that the SOP forms the backbone of regulatory compliance activities in all companies regulated by Good Manufacturing Procedures (GMP) rules and regulations.
Having described the use and importance ascribed to SOP’s it is incongruous to now inform you that the number one failure in compliance is; “not following written instructions”. This is closely followed by the number two failure: “no documented instructions available”.
It is hard for any validation professional to understand the mentality of persons that would patiently wait for a regulatory visitation – knowing it was routine for their operators and laboratory technicians to execute undocumented processes.
It therefore becomes pretty obvious and very essential for the personnel to be trained on these SOPs so that they are aware of why and how SOPs play an important role in fulfilling the specific company’s regulatory requirements from WHO, FDA, EMEA or other national health authorities. Health authorities world-wide like the FDA or EU or HMRA expect pharmaceutical, cosmetic and food producers to use approved manufacturing processes in written SOPs format.
If you have a validation requirement, then make certain the
validation is complete and thorough. Validation documentation must
cascades from the URS to the PQ, with each document properly references
Make certain that your validation is up to regulatory compliance requirements by ensuring that the complete chain is in place.
The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
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The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
Equipment combined IQ/OQ/PQ Protocol.
This combination protocol has been produced in response to several
hundred reader suggestions we received in our ‘Suggestions Section’. It
has been carefully designed to make it the preferred choice for Process
and Laboratory stand alone equipment. It is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.