|
EMEA DRAFT:Annex 15: Qualification and Validation
|
|
0
|
1262
|
February 12, 2014
|
|
Good Pharmacovigilance Practice: Risk-based inspections: UKMHRA
|
|
0
|
1209
|
February 4, 2014
|
|
EMA-EU MSs-FDA initiative on inspections for Generic Applications
|
|
0
|
1137
|
December 19, 2013
|
|
ANVISA: Out sourcing regulations (For comments in Portuguese)
|
|
0
|
1064
|
December 15, 2013
|
|
Questions and Answers on Design Space Verification
|
|
0
|
1174
|
November 7, 2013
|
|
Statistical Analysis in biotech process validation
|
|
1
|
1250
|
October 23, 2013
|
|
PDA Technical Report No. 33 Revised
|
|
0
|
1719
|
October 18, 2013
|
|
FDA guidance :ANDA-Refuse-to-Receive Standards
|
|
0
|
1089
|
October 18, 2013
|
|
FDA Guidance on container labels and Cartons
|
|
0
|
803
|
October 18, 2013
|
|
Line Clearance Procedure
|
|
2
|
1763
|
October 15, 2013
|
|
PDA Technical Report No. 64
|
|
0
|
2350
|
October 13, 2013
|
|
Questions and Answers : ANDAs Stability Testing for drug substances & products
|
|
0
|
964
|
September 30, 2013
|
|
Bioanalytical Method Validation: FDA guidance
|
|
0
|
1013
|
September 29, 2013
|
|
Unique Identification: Final rule
|
|
0
|
759
|
September 29, 2013
|
|
PDA Technical Report No.43(Revised)
|
|
0
|
2029
|
September 17, 2013
|
|
PDA Technical Report No. 63
|
|
0
|
1060
|
September 10, 2013
|
|
USP 39(4) In-Process Revision (July-August 2013)
|
|
0
|
1122
|
September 8, 2013
|
|
Draft guidance on Specification of the Unique Facility Identifier (UFI) System
|
|
0
|
605
|
September 8, 2013
|
|
TGA updates on pharmacovigilance
|
|
0
|
694
|
September 4, 2013
|
|
Ich:guideline for elemental impurities
|
|
0
|
775
|
August 8, 2013
|
|
FDA updated Guidance list
|
|
0
|
724
|
July 31, 2013
|
|
WHO Update: PREQUALIFICATION OF FINISHED PHARMACEUTICAL PRODUCTS
|
|
0
|
608
|
July 23, 2013
|
|
WHO Update: MULTISOURCE (GENERIC) FINISHED PHARMACEUTICAL
|
|
0
|
614
|
July 23, 2013
|
|
WHO GMP Update
|
|
0
|
664
|
July 23, 2013
|
|
FDA UPDATES: ANDA Filing Checklist
|
|
0
|
1146
|
July 23, 2013
|
|
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspe
|
|
0
|
660
|
July 21, 2013
|
|
EU GMP Volume 4: Annex 16 Revision
|
|
0
|
788
|
July 17, 2013
|
|
FDA updates on Cosmetics GMP
|
|
0
|
729
|
July 14, 2013
|
|
Good Manufacturing Practice: The inspection process UK MHRA
|
|
0
|
637
|
July 7, 2013
|
|
Changes in PQS: EMEA
|
|
0
|
700
|
May 31, 2013
|