{"id":3637,"date":"2018-01-17T22:19:09","date_gmt":"2018-01-17T21:19:09","guid":{"rendered":"https:\/\/www.hex-group.eu\/nl_BE\/?p=3637"},"modified":"2020-04-13T16:08:19","modified_gmt":"2020-04-13T15:08:19","slug":"reglementation-bpf-het-ontwerp-van-de-bijlage-1-bekendgemaakt","status":"publish","type":"post","link":"https:\/\/www.hex-group.eu\/nl_BE\/reglementation-bpf-het-ontwerp-van-de-bijlage-1-bekendgemaakt\/","title":{"rendered":"R\u00e9glementation : BPF, Het ontwerp van de Bijlage 1 bekendgemaakt"},"content":{"rendered":"

Het ontwerp van herziening van de Bijlage 1 is sinds 20 december 2017 in openbare raadpleging.<\/h2>\n

\"\"<\/p>\n

De nieuwe tekst, in herziening, van de Bijlage 1<\/strong> van de BPF, gewijd aan de productie van steriele geneesmiddelen<\/strong>, is ter bespreking voorgelegd sinds 20 december 2017. De raadplegingsperiode duurt drie maanden en loopt van 20 december 2017<\/strong> tot 20 maart 2018<\/strong>. Het ontwerp telt vandaag 50 bladzijden terwijl de vorige versie er maar 16 telde.<\/p>\n

Bij de belangrijke wijzigingen, heeft een nieuw hoofdstuk gewijd aan de nutsvoorzieningen<\/strong> zoals water of gas het daglicht gezien en is een onderdeel gewijd aan het risicobeheer<\/strong> (QRM – Quality risk management). Meerdere delen gaan over de Form-Fill-Seal (FFS<\/strong>), Blow-Fill-Seal (BFS<\/strong>) en Single Use Systems (SUS<\/strong>).<\/p>\n

Merk ook het behoud van de indeling van de partikels groter dan of gelijk aan 5 \u00b5m.<\/p>\n

Het project kan op de website van PIC\/S gedownload worden.<\/a><\/p>\n

Inhoudsopgave van het ontwerp<\/h3>\n

1. Scope<\/h4>\n

Additional areas (other than sterile medicinal products) where the general principles of the annex can be applied.<\/p>\n

2. Principle<\/h4>\n

General principles as applied to the manufacture of medicinal products.<\/p>\n

3. Pharmaceutical Quality System (PQS)<\/h4>\n

Highlights the specific requirements of the PQS when applied to sterile medicinal products.<\/p>\n

4. Personnel<\/h4>\n

Guidance on the requirements for specific training, knowledge and skills. Also gives guidance to the qualification of personnel.<\/p>\n

5. Premises<\/h4>\n

General guidance regarding the specific needs for premises design and also guidance on the qualification of premises including the use of barrier technology.<\/p>\n

6. Equipment<\/h4>\n

General guidance on the design and operation of equipment.<\/p>\n

7. Utilities<\/h4>\n

Guidance with regards to the special requirements of utilities such as water, air and vacuum.<\/p>\n

8. Production and specific technologies<\/h4>\n

Discusses the approaches to be taken with regards to aseptic and terminal sterilisation processes. Also discusses different technologies such as lyophilization and Blow Fill Seal (BFS) where specific requirements may be required. Discusses approaches to sterilization of products, equipment and packaging components.<\/p>\n

9. Viable and non-viable environmental and process monitoring<\/h4>\n

This section differs from guidance given in section 5 in that the guidance here applies to ongoing routine monitoring with regards to the setting of alert limits and reviewing trend data.
\nThe section also gives guidance on the requirements of Aseptic Process Simulation.<\/p>\n

10. Quality control (QC)<\/h4>\n

Gives guidance on some of the specific Quality Control requirements relating to sterile medicinal products.<\/p>\n

11. Glossary<\/h4>\n

Explanation of specific terminology.<\/p>\n

Source : www.processpropre.com<\/a><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

Het ontwerp van herziening van de Bijlage 1 is sinds 20 december 2017 in openbare raadpleging. De nieuwe tekst, in herziening, van de Bijlage 1 van de BPF, gewijd aan de productie van steriele geneesmiddelen, is ter bespreking voorgelegd sinds 20 december 2017. De raadplegingsperiode duurt drie maanden en loopt van 20 december 2017 tot… Read more »<\/a><\/p>\n","protected":false},"author":21,"featured_media":3632,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[],"tags":[],"class_list":["post-3637","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"\nR\u00e9glementation : BPF, Het ontwerp van de Bijlage 1 bekendgemaakt - HeX Group<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.hex-group.eu\/nl_BE\/reglementation-bpf-het-ontwerp-van-de-bijlage-1-bekendgemaakt\/\" \/>\n<meta property=\"og:locale\" content=\"nl_BE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"R\u00e9glementation : BPF, Het ontwerp van de Bijlage 1 bekendgemaakt - HeX Group\" \/>\n<meta property=\"og:description\" content=\"Het ontwerp van herziening van de Bijlage 1 is sinds 20 december 2017 in openbare raadpleging. 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