EU-GMP Annex 16 - Qaforum

1 EU-GMP Annex 16 Kai-Uwe Riedel, L kemedelsinspekt rL kemedelsverketInspektion av industri och sjukv rdGruppchef industriQA FORUM Stockholm, 2016-04-13F a r m a k o v i g i l a n sG r u p p c h e fK a t a r i n a A n d e r s s o nS j u k v r dG r u p p c h e fJ e s p e r O r h a m m a rI n d u s t r iG r u p p c h e fK a i-U w e R i e d e lE n h e t s c h e fV i r v e R e i m a n-S u i j k e r b u i j kInspektion av industri och sjukv rd (INSP) sa H gling, handl dGunilla Anheller, utredareBengt Berglund, inspekt r + QAJohn Boutelje, inspekt rEva Kjellin, utredareErik Larsson, inspekt rJavad Mohammadnejad, inspekt rEmil Schwan, inspekt rMaria W ngelin, inspekt rIzabelaMajic, blivande inspekt r, Taina van Eijsbergen, blivande inspekt rGunilla Edman, inspekt rUlla Hultstr m, inspekt rMaria Ingevaldsson, inspekt rAnita J rvinen-Wirell, inspekt rAnn Klintberg, inspekt rHelena Lindberg, inspekt rAnnika Wer en, inspekt r, FLChristina Johansson, inspekt r, vikarieKent Enqvist, inspekt rPernilla L fving.

2 Handl ggareHelena Tidlund, inspekt rLena Ternrud,inspekt rTolkning av nya krav inom GMP och nyheter i EU-GMP :n: Annex kring n gra viktiga omr den i g llande GDP:n Implementering av QualityRisk Management Validering av transporter Supplychainintegrity, kvalificering av leverant rer och enligt kommissionens delegerade f rordning (EU) 2016/161 (best mmelser om s kerhetsdetaljer) avvikelser vid inspektionerTolkning av nya krav inom GMP och nyheter i EU-GMP :n: Annex kring n gra viktiga omr den i g llande GDP:n Implementering av QualityRisk Management Validering av transporter Supplychainintegrity, kvalificering av leverant rer och enligt kommissionens delegerade f rordning (EU) 2016/161 (best mmelser om s kerhetsdetaljer) avvikelser vid inspektionerEU-GMP Annex 16 Deadline for coming intooperation: 15 April 2016 Reasonsfor changes.

3 Globalisationofsupplychain New qualitycontrolstrategies Directive2011/62/EU ( f rfalskningsdirektivet ) ICH Q8, Q9, Q10 MIA interpretation document(part ofCompilation of Community Procedures on Inspections and Exchange of Information) Clarifyingareas wherethe interpretation by MemberStates has not beenconsistentStrukturella ndringar: helt omskrivet! Gamla Annex 16 Nya Annex 161. ScopeScope2. PrincipleGeneral Principles3. Introduction1. The process of certification4. General2. Relying on GMP assessmentsby third parties, Audits5. Batchtesting and release of products manufactured in EC/EEA3.

4 Handling of unexpected deviations6. Batch testing and release of products imported from a third country 4. The release of a batch7. Batch testing and release of products imported from a third country with which the EC has aMRAA ppendix 1, contentof confirm 8. Routine duties of a QPAppendix 2, content batch certificateAnnex 16 General principlesTHE PROCESS OF CERTIFICATION The process of batch release comprises of: i. The checking of the manufacture and testing of the batch in accordance with defined release procedures. ii. The certification of the finished product batch performed by a QP signifying that the batch is in compliance with GMP and the requirements of its MA.

5 This represents the quality release of the batch. iii. The transfer to saleable stock, and/or export of the finished batch of product which should take into account the certification performed by the QP. If this transfer is performed at a site other than that where certification takes place, then the arrangement should be documented in a written agreement between the sites. Tre steg:i. granskning mot MA ochGMP. rdigprodukt, genomf ppningtill s ljbartlager, g rseftercertifiering. M steinteg rasavsakkunnigsj lv, skag rasi enlighetmed skrivnainstruktioneroch/elleravtalAnnex 16 General principlesThe purpose of controlling batch release is notably to ensure that: i.

6 The batch has been manufactured and checked in accordance with the requirements of its MA. ii. The batch has been manufactured and checked in accordance with the principles and guidelines of GMP. iii. Any other relevant legal requirements are taken into account. iv. In the event that a quality defect as referred to in Chapter 8 of EudraLex, Volume 4, Part I, needs to be investigated or a batch recalled, to ensure that any QPs involved in the certification or confirmation and any relevant records are readily identifiable. Anpassningtill kravi i nyakapitel8 (Complaints and product recall), The process of Each batch of finished product must be certified by a QP within the EU before being released for sale or supply in the EU or for export.

7 Certification can only be performed by a QP of the manufacturer and/or importer which are described in the MA. Registreradesakkunnigap den regulatorisktgodk ndacertifieringssitenf rcertifieraf rdigprodukt. Ingetnyttmen The process of Any QP involved in the certification, or confirmation of a batch must have detailed knowledge of the steps for which they are taking responsibility. The QPs should be able to prove their continuous training regarding the product type, production processes, technical advances and changes to GMP. Sakkunnigam stevisa attde hardetaljeradekunskaperom produkt, tillverkningsprocesser, GMP.

8 Sakkunnigam steocks visa attde kontinuerligtvidareutbildasi produktkunskap, tillverkningsprocesser, vissafall kankunskapervaran dv ndigasominten mnsi LVFS 2004:7, 7 . kunskaperi molekyl rbiologivid tillverkningavvissagen The process of There may be several sites involved in the various stages of manufacture, importation, testing and storage of a batch before it undergoes certification. Regardless of how many sites are involved, the QP performing certification of the finished product must ensure that all necessary steps have been completed under accepted pharmaceutical quality systems to assure compliance of the batch with GMP, the MAand any other legal obligations in the Member State where certification is taking place.

9 Sakkunnigsomcertifierarslutproduktintyga rocks attalladelstegi tillverkningensomandrasakkunnigakan konfirmera uppfyllerkraveni MA The process of For manufacturing steps performed at sites in the EU each manufacturing site must have at least one QP. Where the site only undertakes partial manufacturing operations in relation to a batch, then a QP at that site must at least confirmthat the operations undertaken by the site have been performed in accordance with GMP and the terms of the written agreement detailing the operations for which the site is responsible. If the QP is responsible for providing confirmation of compliance for those operations with the relevant MA, then the QP should have access to the necessary details of the MA.

10 Se Annex 16 appendix 1 f r mall somanv ndsf r attkonfirmeracompliance1. The process of For manufacturing steps performed at sites in the EU each manufacturing site must have at least one QP. The QP who performs certification of the finished product batch may assume full responsibilityfor all stages of manufacture of the batch or this responsibility may be shared with other QPs who have provided confirmation for specified steps in the manufacture and control of a batch. These could be other QPs who are operating under the same manufacturing authorisation(MIA) holder or QPs operating under different MIA holders.