Drying validation guidelines

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Process Validation Guideline | 1 Contents 1. Preface 3 2. Introduction 5 3. Glossary 7 4. Building and capturing process knowledge (Stage 1) 13 5. Process qualification (Stage 2) 27 6. Continued process verification (Stage 3) 41 7. Approach to process validation lifecycle of packaging process 49 LOSS ON DRYING (731) ¾Mix and accurately weigh the substance. ¾If the test specimen is in the form of large crystals, reduce the particle size to about 2 mm by quickly crushing. ¾Tare a glass stoppered, shallow weighing bottle that has been dried for 30 minutes under the same conditions ¾Put the test specimen in the bottle. ¾By gentle, sidewise shaking, distribute the test specimen as 3.1 There should be written SOPs detailing the cleaning process for equipment and apparatus. The cleaning procedures should be validated. 3.2 The manufacturer should have a cleaning policy and an appropriate procedure for cleaning validation, covering: • surfaces that come into contact with the product. It is recommended that cycle validation studies shall include a minimum of 3 consecutive, successful lyophilization runs on the worst case load configuration. This guidance provides an overview of freeze drying and considerations for establishing the cycle validation strategy for the lyophilization cycle developed for a given product. KEYWORDS: Process validation, Ly ophilization, QbD, Prima ry Drying, Secondary Dr ying, Freezing, Quality , Sublimation, P A T , Fre eze- Drying. WORLD JOURNAL OF PHARMAC Y AND PHARMACEUTICAL