EU GMP Guidelines Chapter 7

Definition of the term (“What is Chapter 7 of the EU GMP Guide?”)

The EU GMP Gui­dance, Chap­ter 7 is a key part of the EU re­gu­la­to­ry frame­work for phar­maceu­ti­cal ma­nu­fac­tu­ring. This chap­ter fo­cu­ses on out­sour­ced ac­ti­vi­ties, in­clu­ding qua­li­ty con­trol, con­tract ma­nu­fac­tu­ring and ana­ly­sis. Chap­ter 7 of the EU GMP gui­de­lines sets out the re­spon­si­bi­li­ties of phar­maceu­ti­cal com­pa­nies when out­sour­cing cer­tain aspects of pro­duc­tion and ana­ly­sis. It co­vers va­rious aspects of qua­li­ty assu­rance, risk eva­lua­ti­on and re­gu­la­to­ry com­pli­ance in out­sour­ced activities.

Why is compliance with Chapter 7 important?

Com­pli­ance with the EU GMP gui­de­lines, Chap­ter 7, is cru­cial for phar­maceu­ti­cal com­pa­nies to en­su­re the safe­ty and ef­fec­ti­ve­ness of their pro­ducts. Non-com­pli­ance can lead to re­gu­la­to­ry sanc­tions and, abo­ve all, jeo­par­di­ze pa­ti­ent safety.

What are the outsourced activities from chapter 7?

This sec­tion goes into more de­tail on the out­sour­ced ac­ti­vi­ties de­scri­bed in chap­ter 7.

  • Ty­pes of out­sour­ced ac­ti­vi­ties: Chap­ter 7 ca­te­go­ri­zes out­sour­ced ac­ti­vi­ties into dif­fe­rent ty­pes, such as ma­nu­fac­tu­ring, pack­a­ging, la­be­l­ing and ana­ly­ti­cal ve­ri­fi­ca­ti­on. Each spe­ci­es has its own re­qui­re­ments and guidelines. 
  • Risk eva­lua­ti­on: Be­fo­re out­sour­cing an ac­ti­vi­ty, phar­maceu­ti­cal com­pa­nies must per­form a tho­rough risk eva­lua­ti­on. This eva­lua­ti­on helps to iden­ti­fy po­ten­ti­al risks and en­su­re that ap­pro­pria­te risk mi­ti­ga­ti­on me­a­su­res are taken. 
  • Qua­li­ty agree­ments: Qua­li­ty agree­ments play a de­cisi­ve role in out­sour­cing. They de­fi­ne the re­spon­si­bi­li­ties of both the out­sour­cing com­pa­ny and the con­trac­tor and set out the qua­li­ty stan­dards that must be met.

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Regulatory requirements

Un­der­stan­ding the re­gu­la­to­ry re­qui­re­ments is es­sen­ti­al for com­pli­ance with the EU GMP gui­de­lines, Chap­ter 7.

  • Re­gu­la­to­ry aut­ho­ri­ties: Phar­maceu­ti­cal com­pa­nies need to be awa­re of the re­gu­la­to­ry aut­ho­ri­ties in­vol­ved in their out­sour­ced ac­ti­vi­ties. This in­cludes both Eu­ro­pean and na­tio­nal authorities. 
  • Do­cu­men­ta­ti­on: Chap­ter 7 em­pha­si­zes the si­gni­fi­can­ce of pro­per do­cu­men­ta­ti­on. De­tail­ed re­cords of out­sour­ced ac­ti­vi­ties, qua­li­ty agree­ments and risk eva­lua­tions must be main­tai­ned to de­mons­tra­te compliance. 
  • Au­dit and in­spec­tion: Re­gu­lar au­dits and in­spec­tions by re­gu­la­to­ry aut­ho­ri­ties are com­mon in out­sour­ced ac­ti­vi­ties. Com­pa­nies must be pre­pared to car­ry out the­se eva­lua­tions and de­ploy the ne­ces­sa­ry documentation.

Quality control

Qua­li­ty con­trol is a cru­cial aspect of Chap­ter 7.

  • Ve­ri­fi­ca­ti­on and ana­ly­sis
    Phar­maceu­ti­cal com­pa­nies must en­su­re that out­sour­ced test­ing and ana­ly­sis ac­ti­vi­ties are car­ri­ed out in ac­cordance with the spe­ci­fied stan­dards. This in­cludes the va­li­da­ti­on of me­thods and the qua­li­fi­ca­ti­on of devices. 
  • Pro­duct re­lease: The re­spon­si­bi­li­ty for the re­lease of pro­ducts lies with the phar­maceu­ti­cal com­pa­ny. It is im­portant to have clear pro­ce­du­res for the re­lease and cer­ti­fi­ca­ti­on of batches. 
  • Ch­an­ge con­trol: Ch­an­ges to out­sour­ced ac­ti­vi­ties must be careful­ly ma­na­ged and do­cu­men­ted. Chap­ter 7 pro­vi­des no­tes on how ch­an­ge con­trol should be hand­led effectively.

Conclusion

In sum­ma­ry, the EU GMP Gui­dance, Chap­ter 7 is an im­portant part of the EU re­gu­la­to­ry frame­work for phar­maceu­ti­cal ma­nu­fac­tu­ring. Com­pli­ance with this chap­ter is cru­cial to en­su­re the qua­li­ty, safe­ty and ef­fec­ti­ve­ness of me­di­cinal pro­ducts. By fol­lo­wing the gui­de­lines set out in Chap­ter 7, phar­maceu­ti­cal com­pa­nies can con­fi­dent­ly ma­na­ge the com­ple­xi­ties of out­sour­ced activities.

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Frequently Asked Questions (FAQs)

What is the main ob­jec­ti­ve of the EU GMP Gui­dance, Chap­ter 7?
The main ob­jec­ti­ve is to en­su­re the qua­li­ty, safe­ty and ef­fec­ti­ve­ness of me­di­cinal pro­ducts by de­ploy­ing gui­de­lines for out­sour­ced activities.

Who must com­ply with Chap­ter 7 of the EU GMP gui­de­lines?
Phar­maceu­ti­cal com­pa­nies in­vol­ved in out­sour­ced ac­ti­vi­ties, in­clu­ding con­tract ma­nu­fac­tu­ring and ana­ly­sis, must com­ply with Chap­ter 7.

What are the most im­portant com­pon­ents of a qua­li­ty agree­ment?
Among other things, a qua­li­ty agree­ment should de­fi­ne re­spon­si­bi­li­ties, qua­li­ty stan­dards and pro­ce­du­res for ch­an­ge control.

How of­ten should au­dits of out­sour­ced ac­ti­vi­ties be per­for­med?
Au­dits should be car­ri­ed out re­gu­lar­ly, with the fre­quen­cy de­ter­mi­ned by the risk as­so­cia­ted with the out­sour­ced activity.

Can out­sour­cing lead to a re­duc­tion in pro­duct qua­li­ty?
Yes, if not pro­per­ly ma­na­ged, out­sour­cing can pose risks to pro­duct qua­li­ty. Chap­ter 7 of the EU GMP gui­de­lines the­r­e­fo­re em­pha­si­zes the si­gni­fi­can­ce of risk eva­lua­ti­on and qua­li­ty agreements.

What hap­pens in the event of non-com­pli­ance with Chap­ter 7?
Non-com­pli­ance may re­sult in re­gu­la­to­ry sanc­tions, in­clu­ding sus­pen­si­on of ma­nu­fac­tu­ring li­cen­ses and pro­duct recalls.

What is the key prin­ci­ple in Chap­ter 7 of the EU GMP Gui­dance in re­la­ti­on to out­sour­ced ac­ti­vi­ties?
The prin­ci­ple sta­tes that all GMP pro­ces­ses and their sup­port that are out­sour­ced must be ade­qua­te­ly de­fi­ned, agreed and controlled.

What are the re­qui­re­ments for the writ­ten con­tract bet­ween the con­trac­tor and con­trac­ting en­ti­ty for out­sour­ced ac­ti­vi­ties?
The writ­ten con­tract should in­clude all re­spon­si­bi­li­ties and agree­ments made bet­ween the con­trac­tor and the con­trac­ting en­ti­ty in re­la­ti­on to the out­sour­ced activities.

What is the con­trac­ting entity’s task in con­nec­tion with out­sour­ced ac­ti­vi­ties pri­or to out­sour­cing?
Be­fo­re out­sour­cing, the con­trac­ting en­ti­ty is re­spon­si­ble for as­ses­sing the sui­ta­bi­li­ty and com­pe­tence of the contractor.

What does the con­trac­ting en­ti­ty need to en­su­re when it co­mes to con­trol­ling out­sour­ced ac­ti­vi­ties?
The con­trac­ting en­ti­ty must en­su­re that con­trol pro­ces­ses are in place for the as­si­gned ac­ti­vi­ties and that the contractor’s com­pli­ance with GMP prin­ci­ples is guaranteed.

What is the contractor’s re­spon­si­bi­li­ty with re­spect to com­pu­te­ri­zed sys­tems in out­sour­ced ac­ti­vi­ties?
The Con­trac­tor must en­su­re that the ser­vices it pro­vi­des, in par­ti­cu­lar com­pu­ter-ba­sed sys­tems, al­ways meet the re­qui­re­ments set and are sui­ta­ble for the in­ten­ded purpose.

When can out­sour­ced ac­ti­vi­ties and the con­cluded con­tract be sub­ject to in­spec­tion by the com­pe­tent aut­ho­ri­ty?
Out­sour­ced ac­ti­vi­ties and the con­tract con­cluded may be sub­ject to in­spec­tion by the ap­pro­pria­te aut­ho­ri­ty at any time, and the con­trac­tor should be awa­re of this possibility.

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