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-005-2016 Installation & Operational Qualification Requirements for Laboratory Equipment |
|
|
| A-010-2016 Initial Regulatory Check prior to Pre-formulation |
|
|
| A-015-2016 Active Ingredients Check - Approval of Supplier |
|
|
| A-020-2016 Purified Water for Drug Development |
|
|
| A-025-2016 Pre-formulation - Tablets |
|
|
| A-025-2016 From Capsule Pre-formulation to Commercial Lots |
|
|
| A-025-2016 Controlled Release Dosage Forms |
|
|
| A-025-2016 Developing CR Formula |
|
|
| A-025-2016 Pre-formulation - Creams |
|
|
| A-025-2016 Pre-formulation - Liquids |
|
|
| A-030-2016 Non Active Ingredients |
|
|
| A-035-2016 Validating the Semi Active Ingredients |
|
|
| A-040-2016 Container-liner-closure Systems |
|
|
| A-045-2016 Packaging Components - Documentation Requirements |
|
|
| A-050-2016 Finished Product Specifications |
|
|
| A-055-2016 In-process Controls During the Manufacturing Process |
|
|
| A-060-2016 Scale Up Procedures |
|
|
| A-065-2016 Contents of the Technical Transfer Documentation Analytical Part |
|
|
| A-070-2016 Post-approval Changes in Analytical Testing Laboratory Sites |
|
|
| A-075-2016 The Pivotal Batch |
|
|
| A-080-2016 Checklist for Auditing the Pivitol Batch |
|
|
| A-085-2016 Technical Transfer Documentation |
|
|
| A-090-2016 Technical Transfer Documentation for Oral Tablets |
|
|
| A-095-2016 Cleaning Limits and Procedures |
|
|
| A-100-2016 Process Validation Batch |
|
|
| A-105-2016 Process Qualification |
|
|
| A-110-2016 Pre-approval Inspection Team's Set-up and Responsibilities |
|
|
| A-118-2016 Out-Of-Specification Results |
|
|
| A-120-2016 Process Validation |
|
|
| A-125-2016 Process Validation Batch |
|
|
| A-130-2016 Process Validation and Dissolution Requirements |
|
|
| A-135-2016 Bioanalytical HPLC/GC Method Validation for Biostudies |
|
|
| A-175-2016 Process Validation |
|
|
| A-280-2016 Developing the Capsule Formula |
|
|
| A-285-2016 Preformulation - Suspension |
|
|
| A-390-2016 Process validation - flowchart |
|
|
| A-400-2016 Process Optimization - The Big Picture |
|
|
| A-405-2016 Process validation - flowchart |
|
|
| A-410-2016 Process validation - flowchart |
|
|
| A-415-2016 Process validation - The Documentation |
|
|
| A-420-2016 Auditing the Completed Validation Batch Lots |
|
|
Development & Manufacturing
| Engineering
CONTACT VIA EMAIL
-| -
CALL +561 865 6147