It\u2019s audit season, and as CEO of a pharmaceutical packaging company, I\u2019ve seen how a poorly prepared answer can cost weeks of additional work. Here are the 5 most common questions FDA auditors ask about packaging\u2014and how to be ready:<\/p>\n
Can you demonstrate full material traceability?<\/strong><\/p>\n ❌ Problematic answer:<\/strong>\u201cWe track batches in Excel\u201d<\/p>\n ✅ Strong answer: <\/strong>A digital system with QR codes linking each package to raw material certificates, production conditions, and quality testing.<\/p>\n How do you validate packaging-product compatibility?<\/strong><\/p>\n ❌ Problem\u00e1tica: “Seguimos las especificaciones del proveedor”<\/p>\n ✅ S\u00f3lida: Estudios propios de migraci\u00f3n, estabilidad acelerada y pruebas de extractables \/ lixiviables espec\u00edficos para cada formulaci\u00f3n.<\/p>\n What controls are in place to prevent cross-contamination? <\/strong><\/p>\n ❌ Problem\u00e1tica: “Limpiamos las l\u00edneas entre lotes”<\/p>\n ✅ S\u00f3lida: Empaques pre-validados con certificaci\u00f3n de sala limpia, documentaci\u00f3n completa de BPM y sistemas de aire filtrado.<\/p>\n How do you manage specification changes? <\/strong><\/p>\n ❌ Problem\u00e1tica: “Notificamos cuando hay cambios importantes”<\/p>\n ✅ S\u00f3lida: Protocolo de gesti\u00f3n de cambios con evaluaci\u00f3n de impacto, revalidaci\u00f3n cuando aplica y comunicaci\u00f3n formal previa.<\/p>\n Can you demonstrate packaging integrity after sterilization? <\/strong><\/p>\n ❌ Problem\u00e1tica: “Usamos los par\u00e1metros est\u00e1ndar”<\/p>\n ✅ S\u00f3lida: Validaci\u00f3n espec\u00edfica de cada proceso, pruebas de integridad post-esterilizaci\u00f3n y monitoreo continuo.<\/p>\n Pro tip: <\/strong>Preventive documentation is 10 times more cost-effective than corrective documentation.<\/p>\n At Eserplex, our program includes all the documentation you need to confidently answer any regulatory question.<\/p><\/blockquote>","protected":false},"excerpt":{"rendered":" Es temporada de auditor\u00edas, y como CEO de una empresa de empaques farmac\u00e9uticos, he visto c\u00f3mo una respuesta mal preparada puede costar semanas de trabajo adicional. Aqu\u00ed est\u00e1n las 5 preguntas m\u00e1s frecuentes de auditores FDA sobre empaques, y c\u00f3mo prepararse: \u00bfPueden demostrar la trazabilidad completa del material? ❌ Respuesta problem\u00e1tica:“Tenemos los lotes en un…<\/p>","protected":false},"author":1,"featured_media":12437,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-12436","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sin-categorizar","category-1","description-off"],"_links":{"self":[{"href":"https:\/\/eserplex.com\/en\/wp-json\/wp\/v2\/posts\/12436","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eserplex.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eserplex.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eserplex.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/eserplex.com\/en\/wp-json\/wp\/v2\/comments?post=12436"}],"version-history":[{"count":0,"href":"https:\/\/eserplex.com\/en\/wp-json\/wp\/v2\/posts\/12436\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eserplex.com\/en\/wp-json\/wp\/v2\/media\/12437"}],"wp:attachment":[{"href":"https:\/\/eserplex.com\/en\/wp-json\/wp\/v2\/media?parent=12436"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eserplex.com\/en\/wp-json\/wp\/v2\/categories?post=12436"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eserplex.com\/en\/wp-json\/wp\/v2\/tags?post=12436"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}