INTERNATIONAL STANDARD ISO 15378
1 nov. 2011 ISO 9001:2008 with reference to Good. Manufacturing Practice (GMP). Articles de conditionnement primaire pour médicaments — Exigences.
NON-APPLICABLE CLAUSES PERMISSIBLE EXCLUSIONS EXEMPTIONS - PJR
Exemptions For purposes of this presentation we will be referring to both “Permissible Exclusions” and “Non-Applicable Clauses” under the innocuous term “Exemptions ” Exemptions in plain English ISO 9001:2008 and ISO 9001:2015 essentially say the same thing when it comes to Exemptions
ISO 15378 - iTeh Standards
This International Standard incorporates the requirements of ISO 9001:2000 and additionally particular requirements for primary packaging materials which are derived and adapted as appropriate from Good Manufacturing Practices for the production and control of medicinal products
le d-ib td-hu va-top mxw-100p>ISO 9001 All-In-One Kit - Acceptable for ISO 9001 Audit
ISO 9001:2015 The conventions for the layout of this document are the following — Those clauses subclauses or annexes that are quoted directly and unchanged from ISO 9001:2015 and ISO 9000:2015 (under Clause 3) are in boxes — Additional GMP related requirements and recommendations as well as terms and definitions
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