| A-005-2008 Installation & Operational Qualification
Requirements for Laboratory Equipment |
|
REVIEW
|
| A-010-2008 Initial Regulatory Check prior to Pre-formulation |
|
REVIEW
|
| A-015-2008 Active Ingredients Check
- Approval of Supplier |
|
REVIEW
|
| A-020-2008 Purified Water for Drug Development |
|
REVIEW
|
| A-025-2008 Pre-formulation - Tablets |
|
REVIEW
|
| A-025-2008 From Capsule Pre-formulation to Commercial
Lots |
|
REVIEW
|
| A-025-2008 Controlled Release Dosage Forms |
|
REVIEW
|
| A-025-2008 Developing CR Formula |
|
REVIEW
|
| A-025-2008 Pre-formulation - Creams |
|
REVIEW
|
| A-025-2008 Pre-formulation - Liquids |
|
REVIEW
|
| A-030-2008 Non Active Ingredients |
|
REVIEW
|
| A-035-2008 Validating the Semi-Active Ingredients |
|
REVIEW
|
| A-040-2008 Container-liner-closure Systems |
|
REVIEW
|
| A-045-2008 Packaging Components - Documentation
Requirements |
|
REVIEW
|
| A-050-2008 Finished Product Specifications |
|
REVIEW
|
| A-055-2008 In-process Controls During the Manufacturing
Process |
|
REVIEW
|
| A-060-2008 Scale Up Procedures |
|
REVIEW
|
| A-065-2008 Contents of the Technical Transfer Documentation
Analytical Part |
|
REVIEW
|
| A-070-2008 Post-approval Changes in Analytical Testing
Laboratory Sites |
|
REVIEW
|
| A-075-2008 The Pivotal Batch |
|
REVIEW
|
| A-080-2008 Checklist for Auditing the Pivitol Batch |
|
REVIEW
|
| A-085-2008 Technical Transfer Documentation |
|
REVIEW
|
| A-090-2008 Technical Transfer Documentation for
Oral Tablets |
|
REVIEW
|
| A-095-2008 Cleaning Limits and Procedures |
|
REVIEW
|
| A-100-2008 Process Validation Batch |
|
REVIEW
|
| A-105-2008 Process Qualification |
|
REVIEW
|
| A-110-2008 Pre-approval Inspection Team's Set-up
and Responsibilities |
|
REVIEW
|
| A-118-2008 Out-Of-Specification Results |
|
REVIEW
|
| A-120-2008 Process Validation |
|
REVIEW
|
| A-125-2008 Process Validation Batch |
|
REVIEW
|
| A-130-2008 Process Validation and Dissolution Requirements |
|
REVIEW
|
| A-135-2008 Bioanalytical HPLC/GC Method Validation
for Biostudies |
|
REVIEW
|
| A-175-2008 Process Validation |
|
REVIEW
|
| A-280-2008 Developing the capsule formula |
|
REVIEW
|
| A-285-2008 Preformulation - Antibiotic Suspensions
(one step & two step fills) |
|
REVIEW
|
| A-390-2008 Process validation - flowchart |
|
REVIEW
|
| A-400-2008 Process Optimization - The Big Picture |
|
REVIEW
|
| A-405-2008 Process Validation - flowchart |
|
REVIEW
|
| A-410-2008 Process Validation - flowchart |
|
REVIEW
|
| A-415-2008 Process Validation - The Documentation |
|
REVIEW
|
| A-420-2008 Auditing the Completed Validation Batch
Lots |
|
REVIEW
|