Archives: Guidelines

Water system

USFDA: High Purity Water System; Guide To Inspections Of High Purity Water Systems USFDA Inspection

Variations and Changes – NDAs, ANDAs,

USFDA: Changes to an Approved NDA or ANDA USFDA: Changes to an Approved NDA or

Technology Transfer

WHO TRS 1044 – Annex 4: WHO Guidelines on Technology Transfer in Pharmaceutical Manufacturing ISPE:

Storage and Distribution, Transport and

WHO TRS 1025 – Annex 7: Good Storage and Distribution Practices for Medical Products (June

Stratified Sampling – Content Unif

Refer discussions under Questions and Answers on Current Good Manufacturing Practice Regulations | Production and

Stability & Hold time studies

ICH Q1A (R2): Stability Testing: Stability testing of new drug substances and drug products ICH

Sterile Manufacturing

USFDA : Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice – Guidance

Standards (Reference standards, Working

USP Chapter 11: REFERENCE STANDARDS (Access USP) European Pharmacopoeia Chapter 5.12 – Reference Standards (Access

Specifications and Tests

ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances And New Drug

Shared Facilities / Dedicated Facilities

USFDA 21 CFR 211.42: Design and construction features.(Pencillins require dedicated facilities) USFDA Guidance: Non-Penicillin Beta-Lactam