DRUG DEVELOPMENT
" High Quality Cost Effective Drug Development & Manufacturing Excellence World Wide "... .
PREAPPROVAL INSPECTIONS
DRUG DEVELOPMENT
" High Quality Cost Effective Drug Development
& Manufacturing Excellence World Wide "... .
PREAPPROVAL
INSPECTIONS
Development
& Manufacturing
| A-005-2010 Installation & Operational Qualification Requirements for Laboratory Equipment |
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| A-010-2010 Initial Regulatory Check prior to Pre-formulation |
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| A-015-2010 Active Ingredients Check - Approval of Supplier |
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| A-020-2010 Purified Water for Drug Development |
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| A-025-2010 Pre-formulation - Tablets |
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| A-025-2010 From Capsule Pre-formulation to Commercial Lots |
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| A-025-2010 Controlled Release Dosage Forms |
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| A-025-2010 Developing CR Formula |
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| A-025-2010 Pre-formulation - Creams |
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| A-025-2010 Pre-formulation - Liquids |
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| A-030-2010 Non Active Ingredients |
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| A-035-2010 Validating the Semi Active Ingredients |
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| A-040-2010 Container-liner-closure Systems |
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| A-045-2010 Packaging Components - Documentation Requirements |
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| A-050-2010 Finished Product Specifications |
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| A-055-2010 In-process Controls During the Manufacturing Process |
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| A-060-2010 Scale Up Procedures |
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| A-065-2010 Contents of the Technical Transfer Documentation Analytical Part |
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| A-070-2010 Post-approval Changes in Analytical Testing Laboratory Sites |
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| A-075-2010 The Pivotal Batch |
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| A-080-2010 Checklist for Auditing the Pivitol Batch |
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| A-085-2010 Technical Transfer Documentation |
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| A-090-2010 Technical Transfer Documentation for Oral Tablets |
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| A-095-2010 Cleaning Limits and Procedures |
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| A-100-2010 Process Validation Batch |
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| A-105-2010 Process Qualification |
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| A-110-2010 Pre-approval Inspection Team's Set-up and Responsibilities |
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| A-118-2010 Out-Of-Specification Results |
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| A-120-2010 Process Validation |
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| A-125-2010 Process Validation Batch |
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| A-130-2010 Process Validation and Dissolution Requirements |
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| A-135-2010 Bioanalytical HPLC/GC Method Validation for Biostudies |
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| A-175-2010 Process Validation |
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| A-280-2010 Developing the Capsule Formula |
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| A-285-2010 Preformulation - Suspension |
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| A-390-2010 Process validation - flowchart |
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| A-400-2010 Process Optimization - The Big Picture |
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| A-405-2010 Process validation - flowchart |
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| A-410-2010 Process validation - flowchart |
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| A-415-2010 Process validation - The Documentation |
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| A-420-2010 Auditing the Completed Validation Batch Lots |
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Development & Manufacturing
| Engineering
INTERNATIONAL FAX
:- +97250-896-5523
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- 561 865 6147 +1-561-431-2620