Pharmaceutical Expert Report - Tabular Format.doc.docVIP

IIA Composition Format Q1 Page 41 Dosage form Development pharmaceutics Format Q2 Page 43 Development pharmaceutics Format Q3 Page 44 IIB Method of preparation Format Q4 Page 46 Process validation Format Q5 Page 48 IIC Control of starting material Active substance(s) Format Q6 Page 50 scientific data Format Q7 Page 52 Non Pharmacopoeial Active substances scientific data -manufacture Format Q8 Page 53 quality control during manufacture Format Q9 Page 54 development chemistry Format Q10 Page 55 analytical development validation Format Q11 Page 56 Active substance(s) – scientific data impurities Format Q12 Page 57 batch analyses Format Q13 Page 58 Excipients specification and routine tests Format Q14 Page 60 scientific data Format Q15 Page 61 Packaging material immediate packaging Format Q16 Page 63 IID Control tests on intermediate products Format Q17 Page 65 IIE Control tests on the finished product Format Q18 Page 66 scientific data Format Q19 Page 68 IIF Stability stability tests on active substances Format Q20 Page 70 the finished product Format Q21 Page 72 IIQ Other information volume Format Q22 Page 74 TABULAR FORMATS FOR THE PHARMACEUTICAL EXPERT REPORT Notes for guidance on completion of the tabular formats are situated facing the first format to which they refer. COMPOSITION (PART II A) The complete qualitative and quantitative composition of the finished product should be given as a unit and/or percentage formula. For active subs