Page 125 - Efavirenz WHO PQ: A case study of a public-private collaboration

ภาคผนวก 2 สรุปบทเรียน การด าเนินงานในโครงการ WHO PQ ของ ดร.ภญ.มุกดาวรรณ ประกอบไวทยกิจ | 107

ตารางที่ 3 Annex II Technical Data for WHO/CTD format 2010 (ต่อ)
WHO/CTD FORMAT 2010
TITLE LIST OF DOCUMENT FOR LIST OF DOCUMENT FOR
GPO MYLAN
S4.3 Validation of Analytical Procedures 
S4.4 Batch Analyses 
S4.5 Justification of Specification 
S5 Reference Standards or Materials 
S6 Container Closure System 
S7 Stability 
S7.1 Stability Summary and Conclusions 
S7.2 Post-approval Stability Protocol and N/A N/A
Stability Commitment
S7.3 Stability Data 
DRUG PRODUCT
P1 Description and Composition of the Drug 
Product
P2 Pharmaceutical development 
P2.1 Components of the Drug Product 
P2.2 Drug Product 
P2.3 Manufacturing Process Development 

P2.4 Container Closure System 
P2.5 Microbiological Attributes 
P2.6 Compatibility 
P3 Manufacture 
P3.1 Manufacture (s) 
P3.2 Batch Formula 
P3.3 Description of Manufacturing Process and 
Process Controls
P3.4 Control of Critical Steps and 
Intermediates
P3.5 Process Validation and/or Evaluation 
PV protocol & report
- Technology Transfer Report** Technology Transfer Report includes
- List of equipments
- Equipment comparison report for exhibit and
commercial use.
- Details of RLD samples
- Dissolution comparison study with the evaluation of
RSD value.