Temiz Oda Paspas Dokümantasyonu — GMP Denetimine Hazırlık Kontrol Listesi

At minimum, a supplier should provide a lot-specific Certificate of Analysis (COA) with actual test data and a Certificate of Conformance (CoC) referencing the relevant specification. For sterile products, a Certificate of Irradiation (CoI) with dose range data is typically expected. The specific documents required depend on your facility’s quality agreement with the supplier and the cleanroom grade where the product is used.

Look for three indicators: lot-specific numerical test data (not just pass/fail statements), a test date that aligns with the production timeline, and a reference to the test method used. A credible COA includes the analyst or reviewer identification. Cross-check the lot number on the COA against the lot number on the product packaging and your receiving records. If all three match and the data shows actual measurements rather than generic statements, the COA is more likely to be audit-grade.

En sık bahsedilen boşluklar arasında şunlar yer almaktadır: Lota özgü test verileri olmayan COA'lar, kullanımdaki paspas partilerinin tedarikçi belgelerine kadar takip edilememesi, süresi dolmuş veya doğrulanamayan tedarikçi sertifikaları, parçacık üretimi veya kimyasal uyumluluk verilerinin bulunmaması ve "bir yerde dosyada bulunan belgeler"” ancak denetim sırasında makul bir süre içerisinde geri alınamaz. Change control records for mop specification changes are another area auditors have noted.

Hayır. Dokümantasyon gereksinimleri, ürünün kullanımıyla ilişkili riskle orantılı olmalıdır. A/B Sınıfı aseptik alanda kullanılan steril bir paspas, genellikle CoI, sterilite güvence verileri ve ambalaj bütünlüğü belgelerini içeren tam belge paketini gerektirir. C/D Sınıfı alanlarda kullanılan steril olmayan bir paspas, sterilite dokümantasyonu gerektirmez ancak yine de kalite belgelerine (COA, CoC), malzeme bileşimi verilerine ve uygulamasıyla ilgili performans verilerine sahip olmalıdır. Spesifik dokümantasyon beklentileri tesisinizin kalite anlaşmasında ve risk değerlendirmesinde tanımlanmalıdır.

Organize by product type first (sterile vs. non-sterile), then by supplier, then by lot number. Maintain a summary index page that lists each product, supplier, lot numbers in current use, and the location of corresponding documentation. A physical binder with tabbed sections is common, but a well-organized electronic repository with clear naming conventions and searchable metadata can be equally effective — provided the auditor can access it and you can retrieve any document within a few minutes.

First, document your specific documentation requests and the supplier’s response. Second, perform a risk assessment: can your facility accept the documentation gap given the cleanroom grade and application? Third, begin evaluating alternative suppliers who can provide audit-grade documentation. The supplier qualification process for a new mop supplier should include a documentation review as an early gate — before technical evaluation or pricing discussion. A supplier that cannot produce a credible COA during the evaluation phase is unlikely to improve after you become a customer.

Supplier certifications (e.g., ISO certificates) should be verified at least annually or as specified in your supplier qualification SOP. COAs and CoIs should be reviewed for each received lot as part of incoming inspection. Change notification processes should be continuously monitored — not just during scheduled re-audits. A good practice is to add a quarterly documentation health check to the QA calendar: pick one supplier and one product type, request the full documentation package, and verify completeness and currency.