A-005-2019 Installation & Operational Qualification
Requirements for Laboratory Equipment |
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REVIEW
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A-010-2019 Initial Regulatory Check prior to Pre-formulation |
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REVIEW |
A-015-2019 Active Ingredients Check
- Approval of Supplier |
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REVIEW
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A-020-2019 Purified Water for Drug Development |
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REVIEW
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A-025-2019 Pre-formulation - Tablets |
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REVIEW
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A-025-2019 From Capsule Pre-formulation to Commercial
Lots |
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REVIEW
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A-025-2019 Controlled Release Dosage Forms |
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REVIEW
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A-025-2019 Developing CR Formula |
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REVIEW
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A-025-2019 Pre-formulation - Creams |
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REVIEW
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A-025-2019 Pre-formulation - Liquids |
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REVIEW
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A-030-2019 Non Active Ingredients |
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REVIEW
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A-035-2019 Validating the Semi-Active Ingredients |
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REVIEW
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A-040-2019 Container-liner-closure Systems |
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REVIEW
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A-045-2019 Packaging Components - Documentation
Requirements |
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REVIEW
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A-050-2019 Finished Product Specifications |
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REVIEW
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A-055-2019 In-process Controls During the Manufacturing
Process |
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REVIEW
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A-060-2019 Scale Up Procedures |
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REVIEW
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A-065-2019 Contents of the Technical Transfer Documentation
Analytical Part |
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REVIEW
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A-070-2019 Post-approval Changes in Analytical Testing
Laboratory Sites |
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REVIEW
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A-075-2019 The Pivotal Batch |
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REVIEW
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A-080-2019 Checklist for Auditing the Pivitol Batch |
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REVIEW
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A-085-2019 Technical Transfer Documentation |
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REVIEW
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A-090-2019 Technical Transfer Documentation for
Oral Tablets |
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REVIEW
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A-095-2019 Cleaning Limits and Procedures |
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REVIEW
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A-100-2019 Process Validation Batch |
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REVIEW
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A-105-2019 Process Qualification |
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REVIEW
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A-110-2019 Pre-approval Inspection Team's Set-up
and Responsibilities |
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REVIEW
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A-118-2019 Out-Of-Specification Results |
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REVIEW
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A-120-2019 Process Validation |
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REVIEW
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A-125-2019 Process Validation Batch |
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REVIEW
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A-130-2019 Process Validation and Dissolution Requirements |
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REVIEW
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A-135-2019 Bioanalytical HPLC/GC Method Validation
for Biostudies |
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REVIEW
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A-175-2019 Process Validation |
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REVIEW
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A-280-2019 Developing the capsule formula |
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REVIEW
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A-285-2019 Preformulation - Antibiotic Suspensions
(one step & two step fills) |
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REVIEW
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A-390-2019 Process validation - flowchart |
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REVIEW
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A-400-2019 Process Optimization - The Big Picture |
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REVIEW
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A-405-2019 Process Validation - flowchart |
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REVIEW
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A-410-2019 Process Validation - flowchart |
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REVIEW
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A-415-2019 Process Validation - The Documentation |
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REVIEW
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A-420-2019 Auditing the Completed Validation Batch
Lots |
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REVIEW
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