IFF QA erfa gruppe d. 2. sept. 2015 Validering Lone Cleveland Andersen, M.Sc. Pharm., GxP-specialist & projektleder

IFF QA erfa gruppe d. 2. sept. 2015 Validering Lone Cleveland Andersen, M.Sc. Pharm., GxP-specialist & projektleder

Hvornår skal QA-erfa møderne i 2016 struktureres? Mødefrekvens hver 2. måned eller 1 gang i kvartalet? Møder aftales for hele kalenderåret Emner og foredragsholdere aftales for 2-3 møder frem og evt. med suppleanter i tilfælde af aflysning ved sygdom, ferie, rejser m.m. Ny emnebank? 2

Kort om rollen som foredrags-holder Den, der er foredragsholder på et erfa møde, udarbejder en power point præsentation af et valgt oplæg, som fremlægges på mødet. Foredragsholder kan selv vælge flere indgangsvinkler til oplægget - f.eks.: a) fortælle generelt om de nye krav vedr. emnet b) fortælle hvordan du og/eller jeres virksomhed vil implementere de nye krav c) fortælle om de erfaringer som du og/eller jeres virksomhed har med nye krav d) fortælle hvordan du og/eller jeres virksomhed fortolkninger de ny krav Foredragsholderens oplæg bliver udgangspunkt for en dialog i erfa gruppen; - så vi alle bliver en lille smule klogere - så vi kan udveksle erfaringer - så vi bruge hinanden 3

Præsentationsmateriale og referat IFF uddeler ikke præsentations materialet på selve mødet; Foredragsholderen sender sin præsentation til formanden via mail LCA@gxp-pharmasupport.dk. Eller medbringer præsentationen på et USB stik på selve mødet. Efter mødet sørger formanden for, at præsentationen sendes til IFF sekretariat og arkiveres på IFF hjemmesiden under QA erfa mødet den pågældende dato. Formanden tager referat fra mødet og i tilfælde af formandens fravær vælges en af foredragsholderne fra det pågældende erfa møde som referant. Vedkommende sender referat til formanden, LCA. 4

Foredragsholdere for resterende erfa møder, 2015 Erfa møde d. 6. oktober: Emne: Cleaning validation Foredragsholdere: Lone spørger den person fra IFF QA erfa mødet som gerne ville fortælle om sin virksomheds erfaringer Erfa møde d. 1. december: Emner: Mikrobiologi og cellebanker Foredragsholdere: Jytte Hansen fra SSI vil gerne fortælle om cellebanker. Lone spørger Marianne Skovgaard om oplæg vedr. mikrobiologi samt Susanne Holst vedr. Leo s erfaring med skift af PW åndefiltre ifm. SST inspektion. 5

Dagens QA erfa møde d. 2/9 2015 Emne; opdateret Eudralex anneks 15, Validering Tovholdere ændres til foredragsholdere for at undgå misforståelser: Annette Worsaa; afsnit 15.5 Helle Drabøl, afsnit 15.1-15.4, afsnit Lone Cleveland Andersen, afsnit 15.6 til 15.9 Næste gang bør cleaning validation indgå som emne. 6

Content of annex 15 Existing annex Principle Planning for validation Documentation Qualification -DQ/IQ/OQ/PQ Process Validation; -general -prospective validation -concurrent validation -retrospective validation Cleaning validation Change control Re-validation Glossary New annex Principle General Organizing and planning qualification and validation Documentation incl. VMP Qualifications stages for equipment, facilities, utilities, systems; URS/DQ/SAT/IQ/OQ/PQ/ Re-qualification Process Validation* Sec. 15.6: Verification of transport Sec. 15.7: Validation of packaging Sec. 15.8: Qualification of utilities Sec. 15.9: Validation of test methods Cleaning validation* Change control Glossary* * more details included 7

Sec. 15.6, Verification of transportation General aspects: NEW: First time the authorities expects the transportrutes to be verified [GDP Guideline for finished products NOV-2013 / API GDP guideline MAR-2015] 4 Principles: 1. Define product transport condition (storage) 2. Define the transport routes 3. Perform risk assesment 4. Monitor and record the transport conditions

Sec. 15.6, Verification of transportation 1. Transport conditions and storage Includes requirements for: -Finished products -IMP -Bulk Products -Samples These products should be transported from Manufacturing sites according to conditions in MA, approved label, product specification file OR as justified by the manufacturer

Sec. 15.6, Verification of transportation 2. Transport routes Transportation rutes should be clearly defined (be aware of external transporters flights, trains, trucks and alternative routes) Seasonal (summer/winther) and other variational factors should be considered (Variational factors must be defined by risk asasesment or?) Many variable factors may be involved (How to define and evaluate the different transport routes especially of more transporters are used?)

Sec. 15.6, Verification of transportation 3. Risk Assessment Shall include impact of variables of transport other than those conditions continously monitored/controlles (temp, RH%, time) E.g. Delays during transport, failure of monitoring devices, topping up liquid nitrogen, product susceptibility and other relevant factors

Sec. 15.6, Verification of transportation 4. Monitor and record Due to variable conditions during transport, continuesly monitoring and recording of any critical environmental conditions that can affect the product must be in place, unless otherwise justified. How to justify monitoring and recording is not required and ia s risk assessment sufficient as a justification?

Sec. 15.7 Validation of packaging Impact on integrity and the pack Primary and secondary packaging equipment for finished and bulk products should be qualified. Now described as expected Reason for valuidation of 1 and 2 pakaging equp. is now explained: Variation in equipment processeing parameters may have a significant impact on the integrity and correct functioning of the pack (e.g. blister strips, sachets and sterile components).

Sec. 15.7 Validation of packaging Critcial process parameters are now explained: Qualification of equipment used for primary packaging should be carried out at the min. max. operating ranges defined for the critical process parameters: Temperature Machine speed Sealing pressure..or any other factors

Sec. 15.8 Qualification of Utilities NEW Installation qualification: Qualification of steam, water, air, other gasses etc. should be confirmed following the installation qualification steps in section 15.3: URS DQ FAT/SAT IQ OQ PQ

Sec. 15.8 Qualification of Utilities Season variations Period and extent of qualification should reflect any seasonal variations, if applicable, and the intended use of the utility Risk Assesment A risk assesment should be carried out where utilities are: a) In direct contact with the product e.g. Heating, ventilation and aircondictioning (HVAC) b) indirect contact usch as through heat exchangers to mitigrate (reduce) any risk of failure Now risk assesment is included in all validation aspects; which requires a lot of ressources and competences!!

Sec. 15.9 Validation of test methods Detection and quantification limits Al analytical test methods used in the qualification, validation or cleaning exercises should be validated with appropiate detection and quantification limit, where necessary, as defined in Eudralex chapter 6. Cleaning methods of equipement and/or facilities as well?

Sec. 15.9 Validation of test methods Confirmation on NO microbiological influence Where microbial testing of product is carried out, the method should be validated to confirm that the product does not influence the recovery of microorganisms Where microbial testing of surfaces in clean room is carried out, validation should be performed on the test method to confirm that sanitising agents do not influence the recovery of microorganisms.