BRIEFING - PharmOut
that 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
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