Standard Operating Procedure (SOP)

Definition of the term (“What is an SOP?”) 

SOP (Stan­dard Ope­ra­ting Pro­ce­du­re) is the Eng­lish term for the Ger­man term “Stan­dard­ar­beits­an­wei­sung”. This is to be un­ders­tood as a ty­pi­cal pro­ce­du­re or a stan­dar­di­zed se­quence of ac­tions de­scrib­ing pro­ces­ses with re­spect to va­li­da­ting the re­sults and do­cu­men­ting them, espe­cial­ly in cri­ti­cal sec­tors with po­ten­ti­al ef­fects on the en­vi­ron­ment, he­alth and safety.

Which sectors/industries need it? 

They are a re­qui­re­ment for the of­fi­cial aut­ho­riz­a­ti­on, espe­cial­ly in the phar­maceu­ti­cal in­dus­try. This espe­cial­ly af­fects the cer­ti­fi­ca­ti­on of pro­ducts and ser­vices. Sin­ce this is a re­gu­la­to­ry ap­pro­val, the aut­ho­ri­ty also checks the con­tent. It is in­ves­ti­ga­ted whe­ther the­re are vio­la­ti­ons of cor­re­spon­ding pro­ce­du­res. If this is the case, this can re­sult in va­rious con­se­quen­ces down to the pro­hi­bi­ti­on of sel­ling pro­duct or services.

Which advantages does it have? 

Due to the pos­si­ble aut­ho­ri­ta­ti­ve sanc­tions, stan­dard ope­ra­ting pro­ce­du­res are stron­ger than or­di­na­ry work in­st­ruc­tions de­scrib­ing the pro­ce­du­res wi­t­hin an or­ga­niz­a­ti­on etc. Ad­di­tio­nal ad­van­ta­ges of elec­tro­ni­cal­ly do­cu­men­ted SOPs (en­ab­led by the mo­du­le Do­cu­ment Con­trol) are:

  • Ve­ri­fi­ca­ti­on and re­lease pro­ces­ses con­troll­ab­le with workflows
  • Com­pre­hen­si­ve do­cu­ment ma­nage­ment incl. versioning
  • Com­pli­an­ce with all requirements/regulations
  • Elec­tro­nic ma­nage­ment of your spe­ci­fi­ca­ti­ons (e.g. work /process in­st­ruc­tions, test spe­ci­fi­ca­ti­ons, hy­gie­ne plans, ope­ra­ting in­st­ruc­tions), form she­ets, con­tracts and other do­cu­ment types
  • Re­duc­tion of pro­cess run­ti­mes for crea­ti­on, re­vi­si­on, re­lease and dis­tri­bu­ti­on of specifications
  • Easy dis­tri­bu­ti­on of do­cu­ments and use of the si­gna­tu­re circulation
  • Re­duc­tion of un­ne­cessa­ry prin­touts and paper

What are the steps from the creation of an ASOP to it implementation? 

  • Do­cu­men­ta­ti­on (or pro­cess description),
  • Ve­ri­fi­ca­ti­on by a se­cond per­son with si­gna­tu­re and ap­p­lied ve­ri­fi­ca­ti­on criteria
  • No­ti­fi­ca­ti­on and trai­ning of af­fec­ted per­sons as well as
  • Chan­ge ma­nage­ment with op­ti­mi­zed do­cu­men­ta­ti­on and pos­si­b­ly in­for­ma­ti­on on the training

An SOP is do­cu­men­ted in a hand­book. It con­tains a dis­tinct ID, a ver­si­on num­ber, a date or pe­ri­od of va­li­di­ty and the na­mes and si­gna­tures of the creator, ap­pro­ver and re­lea­ser. This in­for­ma­ti­on en­su­red a com­pre­hen­si­ve tracea­bi­li­ty of a do­cu­ment. Mo­reo­ver, it must be re­cor­ded that the em­ployees of the or­ga­niz­a­ti­on were in­for­med of the con­tent of an SOP and must be no­ti­fied in case of a chan­ge to an SOP.

Discover the suitable software for your SOP management

Be it work/process in­st­ruc­tions (SOPs), pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons, ope­ra­ting in­st­ruc­tions, con­tracts or any other do­cu­ment ty­pes — you crea­te, re­vi­se and sign them all elec­tro­ni­cal­ly with our “Do­cu­ment Con­trol” mo­du­le. Con­form to ISO stan­dards, EU-GMP, FDA CFR & more. 
Live insight into the GxP-compliant document management system by d.velop Life Sciences

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All gui­de­li­nes for good working prac­ti­ce, which are par­ti­cu­lar­ly im­portant in me­di­ci­ne, phar­ma­cy and phar­maceu­ti­cal che­mi­stry, are sum­ma­ri­sed by the ab­bre­via­ti­on GxP. The “G” stands for

Functional specification

De­fi­ni­ti­on of the term („What is a func­tio­n­al spe­ci­fi­ca­ti­on?“) A func­tio­n­al spe­ci­fi­ca­ti­on con­tains a contractor’s de­tail­ed de­scrip­ti­on how he in­tends to sol­ve the cus­to­mers requirements.