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  • Annex 1 Showcases The Need For Clear Guidance

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    Mina Maher Mikhail
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    Annex 1 Showcases the Need for Clear Guidance

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    10 visualizações4 páginas

    Annex 1 Showcases The Need For Clear Guidance

    Enviado por

    Mina Maher Mikhail
    showcase

    Direitos autorais:

    © All Rights Reserved
    Baixe no formato PDF ou leia online no Scribd
    Sinalizar o conteúdo como inadequado
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    PDA tetter Annex 1 Showcases the Need for Clear Guidance by: Geer Vandenbossche, Novartis; Mare Besson, Sanof: Gabriele Gri, GSK Vaccines; Jett Christensen, Nove Norsk: Gerry Moris, 2017 Lily and Company [Jan 10, Developing regulatory documents that span many countries languages, and cultures is a formidable task and, despite the best of intentions, often resus in clisagreement as to how to interpret the content. There ae a numberof examples fom regulatory guidance documents that ilusrate the challenges face by the industry practitioners responsible for carrying our the requirements, EU GMP Annex 1, which is currently under revision, has a umber of requirements that have bean interpreted variously jy regulators and irms—nterpretations that may nat have been the inant ofthe original authors. For example, equiement 111 in Annex 1 states The final sterile filtration should be carried out as close as possible to the filling point. Tis cul be taken to mean thatthe final ter should be as physlaly closet the lng operation as equipment design permits |, being 1m alstat is preferable ing post‘vation would be sterile, and contamination between the fier and he pont of ilwould be equaly unacceptable and impactful regardless of the tubing length? Tubing, depending on materiale of const co being Sm cstant. Buthow does thatinterpretavon add ary value to product quality, since the increased length of ‘on, ean adsorb formulation components, but minimizing adsorption i clearly no the intention ofthis requcernent, What is missing from the requirement isthe underlying intent, Seemingly, his apples Co sterlty assurance, butts undear howt apples to this area, Perhaps the authors intended to minimize the potential for subsequent contamination after fration by eliminating or minimizing the number of connections between fina ration and point ofa IFso,e would be helpulto practioners and inspectors evaluating compliance that intent was clearly state, ie, the lie from final fiter othe point of llshoulé be of continuous construction, where possible, inorder to minimize the potential for ingress of contamination. Writen justiiation must be available to support the adopted approach for those es when tis not possible fer continuous construction, Continuing with fitration, requirement 113 states The integrity of the sterilised filter should be verified before use and should be confirmed immediately after use by an appropriate method such as a bubble point, diffusive flow or pressure hold test. In many situations, performing after integrity test ona steriized iter prior to use may inveduce unnecessary rskto the process due tothe adtonal ‘anipubitions ané connections required. While thas ben suggestes that product residue could plug small hole ina sterlized ker thereby, masking 3 nonintegral filter, no published data supports ths tneory. Perhaps, under unique circumstances, could be possible for instance, during aggregation of large protein molecules, but na evidence exists ot occurring inthe vast majority of situations. Furthermore, if refiration is used to minimize bioburden prior tinal Sterile ration ne ine parsculate matte would be present to plug membrane defects. Adcing quid and gas piping, and the associated valves, vent ites ard ‘wetting uid reserves toa fieation system that allows for pos-sterllzaion integrity testing prior to use increases the potental risk of introducing contamination. I ‘Would, therefor, be beneficial to apaly risk management to eaen skuation and fo eliminate tis requirement where justified ‘Another requirement that hasled to divergent interpretations is requirement 117, which states: Containers should be closed by appropriately validated methods. Containers clased by fusion, e.g. glass or plastic ampoules should be subject to 10036 integrity testing. Samples of other containers should be checked for integrity according to appropriate procedures. How this appless very clear for containers loses by fusion, but rather vague for ether containers. ist, itis unelear whether the samples referenced are pat ofr process checks or ae required tobe sampled and tested as part ofeach bath release. Second, the term “appropriate procedures” may be interpreted to include in process checks (suchas evaluation by camera) or checks of capping parameter (such as appled pressures) Requtement 117 has alo been interpreted to mean a scrote container integrity test must be performed on samples of each ished batch, Since the capping equipment and process would have been validated to generate container/losure systems tnat meet container closure Integrity (CI) requirements, CCI testing per batch should not be required if process monitoring has require routine Cl ‘ensure that validated parameters have been met continuously. Based on this rationale the autnors of Annex 1 may nt have intended « ng bu the current wording cerainly leads many to conchide such testing required ‘Another challenge facing both industy practitioners and regulators is ensuring that ¢GMPs are based on good scence. Clearly stating the cient pineples being adoressed ina documents extremely important, as demonstrated by fiterface a vlocty in

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