| A-005-2010 Installation & Operational Qualification
Requirements for Laboratory Equipment |
|
REVIEW
|
| A-010-2010 Initial Regulatory Check prior to Pre-formulation |
|
REVIEW
|
| A-015-2010 Active Ingredients Check
- Approval of Supplier |
|
REVIEW
|
| A-020-2010 Purified Water for Drug Development |
|
REVIEW
|
| A-025-2010 Pre-formulation - Tablets |
|
REVIEW
|
| A-025-2010 From Capsule Pre-formulation to Commercial
Lots |
|
REVIEW
|
| A-025-2010 Controlled Release Dosage Forms |
|
REVIEW
|
| A-025-2010 Developing CR Formula |
|
REVIEW
|
| A-025-2010 Pre-formulation - Creams |
|
REVIEW
|
| A-025-2010 Pre-formulation - Liquids |
|
REVIEW
|
| A-030-2010 Non Active Ingredients |
|
REVIEW
|
| A-035-2010 Validating the Semi-Active Ingredients |
|
REVIEW
|
| A-040-2010 Container-liner-closure Systems |
|
REVIEW
|
| A-045-2010 Packaging Components - Documentation
Requirements |
|
REVIEW
|
| A-050-2010 Finished Product Specifications |
|
REVIEW
|
| A-055-2010 In-process Controls During the Manufacturing
Process |
|
REVIEW
|
| A-060-2010 Scale Up Procedures |
|
REVIEW
|
| A-065-2010 Contents of the Technical Transfer Documentation
Analytical Part |
|
REVIEW
|
| A-070-2010 Post-approval Changes in Analytical Testing
Laboratory Sites |
|
REVIEW
|
| A-075-2010 The Pivotal Batch |
|
REVIEW
|
| A-080-2010 Checklist for Auditing the Pivitol Batch |
|
REVIEW
|
| A-085-2010 Technical Transfer Documentation |
|
REVIEW
|
| A-090-2010 Technical Transfer Documentation for
Oral Tablets |
|
REVIEW
|
| A-095-2010 Cleaning Limits and Procedures |
|
REVIEW
|
| A-100-2010 Process Validation Batch |
|
REVIEW
|
| A-105-2010 Process Qualification |
|
REVIEW
|
| A-110-2010 Pre-approval Inspection Team's Set-up
and Responsibilities |
|
REVIEW
|
| A-118-2010 Out-Of-Specification Results |
|
REVIEW
|
| A-120-2010 Process Validation |
|
REVIEW
|
| A-125-2010 Process Validation Batch |
|
REVIEW
|
| A-130-2010 Process Validation and Dissolution Requirements |
|
REVIEW
|
| A-135-2010 Bioanalytical HPLC/GC Method Validation
for Biostudies |
|
REVIEW
|
| A-175-2010 Process Validation |
|
REVIEW
|
| A-280-2010 Developing the capsule formula |
|
REVIEW
|
| A-285-2010 Preformulation - Antibiotic Suspensions
(one step & two step fills) |
|
REVIEW
|
| A-390-2010 Process validation - flowchart |
|
REVIEW
|
| A-400-2010 Process Optimization - The Big Picture |
|
REVIEW
|
| A-405-2010 Process Validation - flowchart |
|
REVIEW
|
| A-410-2010 Process Validation - flowchart |
|
REVIEW
|
| A-415-2010 Process Validation - The Documentation |
|
REVIEW
|
| A-420-2010 Auditing the Completed Validation Batch
Lots |
|
REVIEW
|