STANDARD OPERATING PROCEDURES.


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Standard Operating Procedures Introduction.


This image represent standard operating procedures used in pharmaceutical industries.

-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.


IF YOU REQUIRE INFORMATION ABOUT WRITING SOP's THEN CLICK HERE AND THIS LINK WILL TAKE YOU TO THE PAGE FOR - AN SOP for an SOP -. A DOCUMENT OFTEN ASK FOR BY REVIEWING REGULATORS.

Regulatory Importance of SOPs.

This image portrays the use of standard operating procedures as used in industry.

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.


The easy way to cGMP compliance.

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 and scoped.

Make certain that your validation is up to regulatory compliance requirements by ensuring that the complete chain is in place.


VP – URS – DQ - VRA – IQ – OQ – PQ.



STANDARD OPERATING PROCEDURES.



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SOP Equipment Validation.

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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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.
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