Search results with tag "Integrity container"
active substance, excipient and primary container ...
www.ema.europa.euContainer integrity is discussed in ICH Q8, (adopted for human medicinal products only, nevertheless the same principles are also applicable to veterinary medicinal products and containers of sterile substances and containers). 2. Scope The guideline applies to chemical and biological medicinal products for human and veterinary use but is
Investigating an OOS in a Quality Control Laboratory
www.fdanews.comTesting Program Container and Closure Requirements Storage Conditions (Temperature and Humidity) Sampling Plan Sample Handling Choice of Analytical Assays/Tests and Specification ... Container Material Integrity Container and closure must not interact with product.
BRIEFING - PharmOut
www.pharmout.netthat may affect container integrity or cosmetic appearance of the product. (GCDF: D. Hunt.) Correspondence Number—C160024 Comment deadline: January 31, 2016 Add the following: 〈1790〉 VISUAL INSPECTION OF INJECTIONS 1. SCOPE. 1.1 Introduction 1.2 Related Chapters. 1.3 Defect Prevention 2. INTRODUCTION. 2.1 Inspection Process Capability