31 March 2022
                                                                                                                                                   EMA/CHMP/ICH/195040/2022
                                                                                                                                                   Committee for Medicinal Products for Human Use 
                                                                                                                                                   ICH guideline Q14 on analytical procedure development
                                                                                                                                                   Step 2b 
                                                                                                                                                          Transmission to CHMP                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         8 March 2022
                                                                                                                                                          Adoption by CHMP                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             24 March 2022
                                                                                                                                                          Release for public consultation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              31 March 2022
                                                                                                                                                          Deadline for comments                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        31 July 2022
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                                                                                                                                   © European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged.
          
                                
                                
                                
                                
          INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL 
            REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE 
          
          
                      ICH HARMONISED GUIDELINE 
                                 
                                 
           ANALYTICAL PROCEDURE DEVELOPMENT 
                              Q14 
                                
                                
                            Draft version  
                        Endorsed on 24 March 2022 
                      Currently under public consultation 
                                 
                                 
                                 
          
          
          
          
          
          
          
          
                                 
          
          
          
          
          
          
          
          At  Step  2  of  the  ICH  Process,  a  consensus  draft  text  or  guideline,  agreed  by  the 
          appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the 
          regulatory  authorities  of  the  ICH  regions  for  internal  and  external  consultation, 
          according to national or regional procedures. 
                         
                              
                          Q14 
                      Document History 
                            
         Code   History                  Date 
         Q14    Endorsement by the Members of the ICH Assembly  24 March 2022 
                under Step 2 and release for public consultation. 
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
          
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                                                        ICH HARMONISED GUIDELINE  
                              ANALYTICAL PROCEDURE DEVELOPMENT 
                                                                              Q14   
                                                                 ICH Consensus Guideline 
                                                                                     
                     TABLE OF CONTENTS 
                      
                     1.      INTRODUCTION .................................................................................................................. 2 
                     1.1     Objective of the Guideline ....................................................................................................... 2 
                     2.      SCOPE .................................................................................................................................... 2 
                     2.1     General Considerations for Analytical Procedure Development and Lifecycle Management . 2 
                     2.2     Minimal versus Enhanced Approaches to Analytical Procedure Development ....................... 3 
                     2.3     The Analytical Procedure Lifecycle ......................................................................................... 4 
                     3.      ANALYTICAL TARGET PROFILE (ATP) ........................................................................ 4 
                     4.      KNOWLEDGE  AND  RISK  MANAGEMENT  IN  ANALYTICAL  PROCEDURE 
                     DEVELOPMENT AND CONTINUAL IMPROVEMENT........................................................... 5 
                     4.1     Knowledge Management ......................................................................................................... 5 
                     4.2     Risk Management .................................................................................................................... 5 
                     5.      EVALUATION OF ROBUSTNESS AND PARAMETER RANGES OF ANALYTICAL 
                     PROCEDURES ................................................................................................................................. 6 
                     5.1     Robustness ............................................................................................................................... 6 
                     5.2     Analytical Procedure Parameter Ranges .................................................................................. 6 
                     6.      ANALYTICAL PROCEDURE CONTROL STRATEGY ................................................. 7 
                     6.1     Established Conditions for Analytical Procedures ................................................................... 8 
                     7.      LIFECYCLE MANAGEMENT AND POST-APPROVAL CHANGES OF ANALYTICAL 
                     PROCEDURES ................................................................................................................................. 8 
                     8.      DEVELOPMENT OF MULTIVARIATE ANALYTICAL PROCEDURES ................... 12 
                     9.      DEVELOPMENT OF ANALYTICAL PROCEDURES FOR REAL TIME RELEASE 
                     TESTING: SPECIAL CONSIDERATONS .................................................................................. 16 
                     10.     SUBMISSION OF ANALYTICAL PROCEDURE RELATED INFORMATION ........ 16 
                     10.1  General Regulatory Considerations and Documentation ....................................................... 16 
                     10.2  Documentation for the Enhanced Approach .......................................................................... 17 
                     10.3  Documentation for Multivariate Analytical Procedures and RTRT ....................................... 17 
                     11.     GLOSSARY .......................................................................................................................... 19 
                     12.     REFERENCES ..................................................................................................................... 26 
                     13.     ANNEX ................................................................................................................................. 26 
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