IAGIM - Drug Development Association

IAGIM - PREAPPROVAL INSPECTIONS- Development & Manufacturing

Engineering | Development & Manufacturing

A-005-2019 Installation & Operational Qualification Requirements for Laboratory Equipment   REVIEW
A-010-2019 Initial Regulatory Check prior to Pre-formulation   REVIEW
A-015-2019 Active Ingredients Check - Approval of Supplier   REVIEW
A-020-2019 Purified Water for Drug Development   REVIEW
A-025-2019 Pre-formulation - Tablets   REVIEW
A-025-2019 From Capsule Pre-formulation to Commercial Lots   REVIEW
A-025-2019 Controlled Release Dosage Forms   REVIEW
A-025-2019 Developing CR Formula   REVIEW
A-025-2019 Pre-formulation - Creams   REVIEW
A-025-2019 Pre-formulation - Liquids   REVIEW
A-030-2019 Non Active Ingredients   REVIEW
A-035-2019 Validating the Semi-Active Ingredients   REVIEW
A-040-2019 Container-liner-closure Systems   REVIEW
A-045-2019 Packaging Components - Documentation Requirements   REVIEW
A-050-2019 Finished Product Specifications   REVIEW
A-055-2019 In-process Controls During the Manufacturing Process   REVIEW
A-060-2019 Scale Up Procedures   REVIEW
A-065-2019 Contents of the Technical Transfer Documentation Analytical Part   REVIEW
A-070-2019 Post-approval Changes in Analytical Testing Laboratory Sites   REVIEW
A-075-2019 The Pivotal Batch   REVIEW
A-080-2019 Checklist for Auditing the Pivitol Batch   REVIEW
A-085-2019 Technical Transfer Documentation   REVIEW
A-090-2019 Technical Transfer Documentation for Oral Tablets   REVIEW
A-095-2019 Cleaning Limits and Procedures   REVIEW
A-100-2019 Process Validation Batch   REVIEW
A-105-2019 Process Qualification   REVIEW
A-110-2019 Pre-approval Inspection Team's Set-up and Responsibilities   REVIEW
A-118-2019 Out-Of-Specification Results   REVIEW
A-120-2019 Process Validation   REVIEW
A-125-2019 Process Validation Batch   REVIEW
A-130-2019 Process Validation and Dissolution Requirements   REVIEW
A-135-2019 Bioanalytical HPLC/GC Method Validation for Biostudies   REVIEW
A-175-2019 Process Validation   REVIEW
A-280-2019 Developing the capsule formula   REVIEW
A-285-2019 Preformulation - Antibiotic Suspensions (one step & two step fills)   REVIEW
A-390-2019 Process validation - flowchart   REVIEW
A-400-2019 Process Optimization - The Big Picture   REVIEW
A-405-2019 Process Validation - flowchart   REVIEW
A-410-2019 Process Validation - flowchart   REVIEW
A-415-2019 Process Validation - The Documentation   REVIEW
A-420-2019 Auditing the Completed Validation Batch Lots   REVIEW


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