GAMP5

Definition of the term (“What is the GAMP5?”)

The GAMP5 is a set of gui­de­lines and best prac­ti­ces de­ve­lo­ped by the In­ter­na­tio­nal So­cie­ty for Phar­maceu­ti­cal En­gi­nee­ring (ISPE) to en­su­re the qua­li­ty and com­pli­ance of au­to­ma­ted sys­tems in the phar­maceu­ti­cal and he­alth­ca­re in­dus­tries. GAMP stands for “Good Au­to­ma­ted Ma­nu­fac­tu­ring Prac­ti­ce”. This is the fifth ver­si­on of the­se gui­de­lines, which ta­kes into ac­count the la­test in­dus­try de­ve­lo­p­ments and re­gu­la­to­ry changes.

Why is the GAMP5 important?

The phar­maceu­ti­cal in­dus­try re­li­es hea­vi­ly on au­to­ma­ted sys­tems for va­rious pro­ces­ses, in­clu­ding ma­nu­fac­tu­ring, qua­li­ty con­trol and data ma­nage­ment. En­su­ring the re­lia­bi­li­ty and in­te­gri­ty of the­se sys­tems is cru­cial to pre­vent er­rors that could jeo­par­di­ze the safe­ty and ef­fec­ti­ve­ness of products.

The GAMP5 ad­dres­ses this need by de­ploy­ing a struc­tu­red frame­work for the va­li­da­ti­on and main­ten­an­ce of au­to­ma­ted sys­tems. It not only helps to meet re­gu­la­to­ry re­qui­re­ments, but also im­pro­ves over­all ope­ra­tio­nal efficiency.

What are the principles of GAMP5?

GAMP5 is ba­sed on se­ve­ral key principles:

  • Risk-ba­sed ap­proach: A fun­da­men­tal com­po­nent of GAMP5 is the ap­pli­ca­ti­on of a risk-ba­sed ap­proach. It re­co­gni­zes that not all sys­tems are equal­ly cri­ti­cal and fo­cu­ses va­li­da­ti­on ef­forts whe­re they are most nee­ded. This ap­proach en­su­res an ef­fi­ci­ent al­lo­ca­ti­on of resources. 
  • Do­cu­men­ta­ti­on and re­cords: Pro­per do­cu­men­ta­ti­on is at the he­art of GAMP5. It re­qui­res tho­rough do­cu­men­ta­ti­on of all aspects of the au­to­ma­ted sys­tem, from de­sign and de­ve­lo­p­ment to test­ing and main­ten­an­ce. This me­ti­cu­lous re­cor­ding helps to pro­ve com­pli­ance to su­per­vi­so­ry authorities. 
  • Ch­an­ge con­trol: Ch­an­ge is ine­vi­ta­ble in any in­dus­try, and the phar­maceu­ti­cal sec­tor is no ex­cep­ti­on. GAMP5 em­pha­si­zes the si­gni­fi­can­ce of ef­fec­ti­ve ch­an­ge con­trol pro­ce­du­res to en­su­re that mo­di­fi­ca­ti­ons to au­to­ma­ted sys­tems do not com­pro­mi­se their in­te­gri­ty or compliance.

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Our di­gi­tiza­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the dls | eQMS is a ho­li­stic ECM/DMS sys­tem. The ECM/DMS sys­tem can be con­nec­ted to your exis­ting ERP sys­tem (e.g. SAP) and thus map al­most all do­cu­ment-ba­sed pro­ces­ses in the company.

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How can the GAMP5 be implemented?

The im­ple­men­ta­ti­on of GAMP5 in a phar­maceu­ti­cal com­pa­ny com­pri­ses se­ve­ral steps:

  • Risk eva­lua­ti­on: The pro­cess be­g­ins with a com­pre­hen­si­ve risk eva­lua­ti­on to iden­ti­fy cri­ti­cal sys­tems and po­ten­ti­al th­re­ats. This eva­lua­ti­on in­forms the prio­ri­tiza­ti­on of va­li­da­ti­on efforts. 
  • User re­qui­re­ment spe­ci­fi­ca­ti­on: Com­pa­nies need to de­fi­ne clear and de­tail­ed user re­qui­re­ments for their au­to­ma­ted sys­tems. This do­cu­ment ser­ves as the ba­sis for sys­tem de­sign and validation. 
  • Sys­tem de­sign and de­ve­lo­p­ment: The au­to­ma­ted sys­tem is de­si­gned and de­ve­lo­ped ba­sed on the user re­qui­re­ment spe­ci­fi­ca­ti­on. GAMP5 pro­vi­des gui­de­lines to en­su­re that the sys­tem ful­fills its in­ten­ded purpose. 
  • In­stal­la­ti­on and ope­ra­tio­nal qua­li­fi­ca­ti­on (IQ/OQ): IQ/OQ tests ve­ri­fy that the sys­tem is in­stal­led cor­rect­ly and ope­ra­tes ac­cor­ding to its de­sign spe­ci­fi­ca­ti­ons. This pha­se is cru­cial for sys­tem validation. 
  • Per­for­mance qua­li­fi­ca­ti­on (PQ): PQ tests con­firm that the sys­tem works con­sis­t­ent­ly wi­thin de­fi­ned pa­ra­me­ters and meets user re­qui­re­ments. A suc­cessful PQ is an im­portant mi­le­stone in the va­li­da­ti­on process.

What are the advantages of GAMP5?

The im­ple­men­ta­ti­on of GAMP5 of­fers num­e­rous ad­van­ta­ges for phar­maceu­ti­cal companies:

  • Re­gu­la­to­ry Com­pli­ance: GAMP5 helps com­pa­nies en­su­re com­pli­ance with in­dus­try re­gu­la­ti­ons and gui­de­lines and re­du­ce the risk of cos­t­ly re­gu­la­to­ry is­sues and pro­duct recalls.

  • Im­pro­ved pro­duct qua­li­ty: By en­su­ring the re­lia­bi­li­ty of au­to­ma­ted sys­tems, GAMP5 con­tri­bu­tes to the pro­duc­tion of high-qua­li­ty phar­maceu­ti­cal products.

  • In­crease in ef­fi­ci­en­cy: Ef­fi­ci­ent­ly va­li­da­ted sys­tems lead to less down­ti­me and ope­ra­tio­nal in­ter­rup­ti­ons, re­sul­ting in in­creased ef­fi­ci­en­cy and productivity.

  • Risk mi­ni­miza­ti­on: GAMP5’s risk-ba­sed ap­proach en­ables com­pa­nies to fo­cus re­sour­ces on cri­ti­cal sec­tions and mi­ni­mi­ze the risk of sys­tem fail­ures and errors.

Conclusion

In sum­ma­ry, GAMP5 is an in­dis­pensable tool for phar­maceu­ti­cal com­pa­nies that want to main­tain high qua­li­ty and com­pli­ance stan­dards in their au­to­ma­ted sys­tems. By ad­he­ring to its prin­ci­ples and gui­de­lines, com­pa­nies can im­pro­ve their ope­ra­ti­ons, re­du­ce risks and ul­ti­m­ate­ly de­li­ver safer and more ef­fec­ti­ve phar­maceu­ti­cal products.

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Frequently Asked Questions (FAQs)

What is GAMP5?
GAMP5 stands for “Good Au­to­ma­ted Ma­nu­fac­tu­ring Prac­ti­ce 5” and is a set of gui­de­lines for en­su­ring the qua­li­ty and com­pli­ance of au­to­ma­ted sys­tems in the phar­maceu­ti­cal industry.

Who de­ve­lo­ped GAMP5?
GAMP5 was de­ve­lo­ped by the In­ter­na­tio­nal So­cie­ty for Phar­maceu­ti­cal En­gi­nee­ring (ISPE).

Why is GAMP5 im­portant for phar­maceu­ti­cal com­pa­nies?
GAMP5 is im­portant for phar­maceu­ti­cal com­pa­nies to en­su­re the re­lia­bi­li­ty, com­pli­ance and qua­li­ty of their au­to­ma­ted sys­tems and to re­du­ce the risk of re­gu­la­to­ry is­sues and pro­duct recalls.

What ad­van­ta­ges does GAMP5 of­fer phar­maceu­ti­cal com­pa­nies?
GAMP5 be­ne­fits phar­maceu­ti­cal com­pa­nies by im­pro­ving re­gu­la­to­ry com­pli­ance, enhan­cing pro­duct qua­li­ty, in­cre­asing ef­fi­ci­en­cy and mi­ni­mi­zing risks in au­to­ma­ted systems.

What fac­tors in­fluence the va­li­da­ti­on ef­fort ac­cor­ding to GAMP, and how is the scope and num­ber of con­trols for a com­pu­te­ri­zed sys­tem wi­thin the frame­work of func­tion­al risk ma­nage­ment de­ter­mi­ned?
In prac­ti­ce, the va­li­da­ti­on ef­fort ac­cor­ding to GAMP de­pends on the data se­cu­ri­ty pa­ra­me­ters, the com­ple­xi­ty and the no­vel­ty of the IT sys­tem used. This ch­an­ges the way we see and work and con­scious de­cis­i­ons have to be made. In­iti­al ba­sic risk eva­lua­ti­on is per­for­med and then the im­pacts of the sys­tem are ana­ly­sed. The func­tions that have an im­pact on data se­cu­ri­ty, pro­duct qua­li­ty and data in­te­gri­ty are then iden­ti­fied. Ba­sed on the func­tions, func­tion­al risk ma­nage­ment be­g­ins and the scope and num­ber of con­trols of the com­pu­te­ri­sed sys­tem are de­fi­ned. The­se must then be im­ple­men­ted and ve­ri­fied ac­cor­din­gly. The re­sul­ting mo­ni­to­ring of the en­ti­re life­cy­cle en­ables the op­ti­miza­ti­on of work­flows and pro­ces­ses, such as the avo­id­ance of du­pli­ca­te ac­ti­vi­ties th­rough the in­te­gra­ti­on of com­pu­ter sys­tem activities.

What re­qui­re­ments and pre­re­qui­si­tes should be con­side­red when sel­ec­ting and working with an IT sup­pli­er in a re­gu­la­ted en­vi­ron­ment, par­ti­cu­lar­ly with re­gard to qua­li­ty assu­rance and com­pli­ance?
If a com­pa­ny in a re­gu­la­ted en­vi­ron­ment wis­hes to be streng­the­ned by the work of an IT sup­pli­er, the ap­proach of pre-ve­ri­fi­ca­ti­on of the sui­ta­bi­li­ty and re­lia­bi­li­ty of the sup­pli­er also ap­pli­es here. The IT com­pa­ny, in turn, must con­sis­t­ent­ly im­ple­ment the agreed qua­li­ty assu­rance me­a­su­res and the­r­e­fo­re co­mes un­der grea­ter scru­ti­ny by the su­per­vi­so­ry aut­ho­ri­ties. This re­sults in a num­ber of re­qui­re­ments for the sup­pli­er. In this con­text, GAMP5 con­siders qua­li­ty-assu­red soft­ware de­ve­lo­p­ment in ac­cordance with a life­cy­cle mo­del, the V‑model, qua­li­ty-assu­red and do­cu­men­ted ad­apt­a­ti­on and im­ple­men­ta­ti­on of the soft­ware and cor­re­spon­ding qua­li­ty-assu­red main­ten­an­ce and sup­port to be ap­pro­pria­te. The aspects have to be il­lus­tra­ted ba­sed on a qua­li­ty ma­nage­ment system.

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ISO certification

De­fi­ni­ti­on of the term (“What does ISO cer­ti­fi­ca­ti­on mean?”)  The ISO cer­ti­fi­ca­ti­on is a pro­ce­du­re that ser­ves the pur­po­se of de­mons­t­ra­ting com­pli­ance with cer­tain requirements.