IAGIM - Drug Development Association

IAGIM - PREAPPROVAL INSPECTIONS- Development & Manufacturing

Engineering | Development & Manufacturing

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


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