LA SPEDIZIONE AI SITI CLINICI E LA SUCCESSIVA ... SPEDIZIONE AI SITI CLINICI E LA SUCCESSIVA...

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LA SPEDIZIONE AI SITI CLINICI E LA SUCCESSIVA

GESTIONE DELL’IMP

Luciano Gambini

GMP Consultant


GESTIONE DELL’IMP

Annex 13 - Investigational Medicinal Products

Brussels, 03 February 2010 - ENTR/F/2/AM/an D(2010) 3374

RILASCIO DEI LOTTI

Investigational medicinal products should remain under the control of the sponsor until after completion of a two-step procedure:

• certification by the Qualified Person;

• and release by the sponsor for use in a clinical trial following fulfillment of the requirements of Article 9 (Commencement of a clinical trial) of Directive 2001/20/EC. Both steps should be recorded and retained in the relevant trial files held by or on behalf of the sponsor

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LA SPEDIZIONE AI SITI CLINICI E LA

SUCCESSIVA GESTIONE DELL’IMP



SPEDIZIONE

La spedizione deve avvenire a seguito di un ordine scritto da parte dello Sponsor

Le condizioni di spedizione deve essere date dallo Sponsor

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Sponsor/CRO

Officina/Deposito Ricevimento alla Farmacia;

Verifica di ricezione.

Invio al centro sperimentale

Richiesta di Spedizione

Parere favorevole del C.E.


GESTIONE DELL’IMP

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GESTIONE DELL’IMP

Country: _______________

Centre n°: |__|__|__|

Investigator: _________________________

Date of request:………………..

Consign Supplies to:

Pharmacy:...………………………….

Att.:…………………………………..

Address:…………………………….

Tel.:……………………. Fax.:……………………

E-mail:………………………………..

Material required for study…….

□Initial site supply □ Resupply

Other visits:

For initial supply only, regulatory approval attached.

Request authorized by the Project Manager

Signature________________________ Date:__________

Study ……….

Sponsor ….. Shipment Form Page 1 of 1

Section 1 to be completed by the Study Project Manager

Fax to Manufacturer……….

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GESTIONE DELL’IMP

Date Request

Received:_________________

Shipment number_______________

Attachment: IRB/IEC approval □ Yes □ No □ N.A. CA approval □ Yes □ No □ N.A. Certificate of release of study drug □ Yes □ No □ N.A. Certificate of analysis □ Yes □ No □ N.A. Import License □ Yes □ No □ N.A. Code Break cards □ Yes □ No □ N.A. Treatment code printout □ Yes □ No □ N.A. Proforma Invoice □ Yes □ No □ N.A. Others______________________ □ Yes □ No □ N.A.

Code break cards according to the randomization n° are enclosed with the study

drug.

Dispatched by:_____________________________

Date:_______________________________

Checked by:________________________________

Date:_______________________________

Note:………………………………………………………………………………

……………………………………………………………………………………

Section 2 to be completed by Manufacturer

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GESTIONE DELL’IMP

Date Received:_________________ Shipment received in good conditions: □ Yes □ No

If no,

explain___________________________________________________________

__________

Received by:_____________________________

Date:_______________________________

Upon Receipt: Store securely.

Investigator:______________________________

Date:_______________________________

Fax a copy of the completed form toManufacturer, att.

Keep the original in the Investigator File.

Section 3 to be completed by Investigator or Pharmacist

Fax to Manufacturer att.:



Fornitori esterni

Questi fornitori di servizio devono essere qualificati. Devono dimostrare

che durante il trasporto:

Il materiale è trasportato in condizioni di sicurezza

Le condizioni di conservazione richieste sono mantenute

I tempi di consegna concordati sono rispettati

La documentazione di supporto ( record delle temperature, documenti

di trasporto, ecc.) è disponibile e sufficiente per eseguire indagini in

casi di deviazioni/reclami.

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LA SPEDIZIONE E IL RICHIAMO DI IMP DAI SITI

CLINICI

Inspections - Good Manufacturing Practice - Questions & Answers

EU GMP Guide Annexes - Supplementary Requirements - Annex 13

6. Question (H May 2009):

What measures should be taken to ensure that the IMPs are kept under suitable conditions

during transportation between the manufacturer/distributor and the investigator sites?

Answer:

Storage conditions during transportation should be validated and/or monitored using a suitable

temperature measuring device, capable of showing fluctuations in temperature e.g. Temperature

Logger. The choice of method of transportation should be influenced by the nature and sensitivity

of the product and should ensure timely delivery of IMPs to the investigator sites.

The outer packaging should be labelled showing the final destination, the name of

Manufacturer/sponsor and the required storage conditions

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CLINICI

Kit patient

RELEASE

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Stoccaggio Sito

Clinico Spedizione

GMP GDP GCP

Le GDPs assicurano che il livello qualitativo degli IMPs prodotti secondo GMP è

mantenuto durante il trasporto..

Paziente



European GMP Regulations

Directive 2001/83/EC related to wholesale distribution

Directive 2002/98/EC related to handling of blood and blood products

Directive 2004/23/EC related to the handling of human tissues

Directive 2004/93/EC related to GMP for medicinal products

Directive 2005/28/EC related to clinical trial material

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Normativa di Riferimento


GESTIONE DELL’IMP

La Direttiva 2001/20/CE è stata integralmente trasposta nel Dlgs. N° 211

del 24 Giugno 2003.

La Direttiva 2001/83/CE (e successive direttive di modifica) relativa ad un codice

comunitario concernente i medicinali per uso umano, nonché la direttiva

2003/94/CE ha trovato attuazione nel Dlgs. N° 219 del 24 Aprile 2006.

La Direttiva 2005/28/CE è stata implementata nel Dlgs. N° 200

del 6 Novembre 2007.

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Monitor

Officina

Officina

Inceneritore/Officina

Stoccaggio del reso sino a stesura del

report clinico

Compilazione formulario avvenuta distruzione

Distruzione

Contabilità presso Officina

Farmaci in scadenza ai centri sperimentali o

conclusione dello studio clinico

Reso dai centri – Modulo contabilità GCP


GESTIONE DELL’IMP



Procedura stringente e precisa per richiamo dal centro clinico

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Paziente Medico Monitor Sponsor Officina

Farmacia Monitor Sponsor Officina

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Study code:

Investigator:

Pharmacist:

Address:

Sponsor:

Phone N°:

Site N°:

Details of Defect/Reason for Recall:

Class of Defect:

Drug

Batch Number

Expiry (or use) Date

Dose Form

Dose Strength

Package Unit

Quantity per package (kit)

Specify total quantity returned and units:

Function:

___________________

(Investigator

/Monitor/Pharmacist)

Name:

____________

__________

Signature:

___________

___________

Date:

__________

__________

Please complete this form and enclose it with clinical supplies returned to:

………………………………


GESTIONE DELL’IMP


CLINICI



RETURNS

51. Investigational medicinal products should be returned on agreed conditions

defined by the sponsor, specified in approved written procedures

52. Returned investigational medicinal products should be clearly identified and

stored in an appropriately controlled, dedicated area. Inventory records of the

returned medicinal products should be kept.

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CLINICI



Resi e richiami

Lo sponsor deve assicurarsi che il fornitore del prodotto di confronto abbia un efficace

sistema di comunicazione nel caso di richiamo del prodotto commerciale

I resi devono essere chiaramente identificati e tenuti segregati

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CLINICI



DESTRUCTION

53. The Sponsor is responsible for the destruction of unused and/or returned investigational medicinal products. Investigational medicinal products should therefore not be destroyed without prior written authorization by the Sponsor.

54. The delivered, used and recovered quantities of product should be recorded, reconciled and verified by or on behalf of the sponsor for each trial site and each trial period.

Destruction of unused investigational medicinal products should be carried out for a given trial site or a given trial period only after any discrepancies have been investigated and satisfactorily explained and the reconciliation has been accepted. Recording of destruction operations should be carried out in such a manner that all operations may be accounted for. The records should be kept by the Sponsor.

55. When destruction of investigational medicinal products takes place a dated certificate of, or receipt for destruction, should be provided to the sponsor. These documents should clearly identify, or allow traceability to, the batches and/or patient numbers involved and the actual quantities destroyed.

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CLINICI



Distruzione

Lo Sponsor è responsabile della distruzione

I documenti di distruzione devono permettere la tracciabilità ai lotti/patient kits ed alle

quantità distrutte

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