Ref International Conference on Harmonisation Draft Guidance on QB Regulatory Acceptance of Analytical Procedures and or Acceptance Criteria Published August Docket No D by FDADocs


									     Ref: International Conference on Harmonisation; Draft Guidance on Q4R Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Published August
     8,2006 (Docket No. 2006D-0297)

     PDA's Specific Comments 

    Section       Line No. Comment and Rationale 
                                                                                Proposed rewording (if applicable)
                                                                                                                                  This guideline is intended to facilitate regulatory acceptance of these
                              Change the phrase "in each rcgulatory region" to "across thc rcgulatory rcgions." This              proposed APAC and their interchangeability with thosc APAC
1.2 	             18          change better conveys the concept that harmonization aims to facilitate a common testing 
          contained in the local regional pharmacopoeias. thus avoiding redu~idanl
                              strategy across the regulatory regions and not within each regulatory region. 
                     testing and diffcrent acccptance criteria in favor of a common testing
                                                                                                                                  strategy ncross the regl,latol3' regions.
                                                                                                                                  :.i'he.&;.MIC;...s.~.oLlld      ~c...rj.&~.~~et~...v~f.iiil~.~f lc\1 ....&.h;&./i~..hc.t;n
                                                                                                                                                                                               j:.p.b ..>!.;io,i:;...l.e.;p

                              The statcment needs clarity. It is the rcspons~bility PDG or members of the PDG to notify : .
                                                                                     of                                                           t+ rtte 4(;WE-itr-ticstc7 The lead pharrnacopocia must n o t ~ f y

1.4               44-45
                              the ICH Q4B EWG. The statement as it reads does not assign this responsibility to PDG.              z       4        B EWG of any revisions made to text that has been
                                                                                                                                  submitted and accepted utilizing the Q J B process.
                              The last sentence starting with "Ihrilateral cknng~s/rrvisions. . " should be removed. Lines
                              44-47 seem to satisfactorily cover the appropriate actions that should be taken if a revision to I . 2 n ~ i & - 1 i - 1 i t ~ : f ~ i : t ~ ibj-i ktriy -c;fti'tiie-+nt,iiv~titiiti
                                                                                                                                                                                      ~ i\ 	                                pi+a~+riaetyx;e-;as+%
1.4 	             47/48
                              a text occurs. An automatic voiding of ICH status seems very drastic and in conflict with the wU++&hc -K1#14&&&~5
                              text in lines 44-47.
                              This statement indicates that ICH will be able to revise agreed to text recommended by PDG
                              once comments have been received during the regulatory consultation period. PDG should              Regulatory consultation (generally within 3 months) focuses on thc
                              be consulted on the possiblc changes received during this step in the proccss and should have Q4B Outcomc In the annexed. The atincxcd can bc rcvised based oti
2'1'3             66-67
                              thc ability to revise the text and rc-propose it through their public review proccsscs before thc comments receivcd and ~vititthe crgrrernv,it arid.sigrr uflof t h ~
                              ICH EWG is allowed to officially adopt the tcxt as being harmonized. We propose adding              pharn~acopoeiaproducingthe Af'AC'.
                              the text (in italics) to clarify.
                              Deletc reference to non-PDG sources as it is confusing and seems in conflict with thc intent
3                 92                                                                                                              See General Comment #I in our lettcr.
                              of this document

~3            195-96          1
                              The definition for Non-PDG should be eliminated as it is confusing. The PDG is not the
                              PDG fall three of the pharmacopoe~as not agree. Two of the three act~ng c o a l ~ t ~ o n
                                                                        do                                        In
                              w ~ t h the consent of thc thtrd pharmacopoeta can not be considered "actnig together as the
                              PDG". Please see suggested replaccment wordlng for "non-PDG" In bullet polnt 2 In the
                                                                                                                                  k- -             ( ) t i t t b t t*tt 	 ttl ~ e t i + ~ a ! p i t ~ i + r i , ~ ti + t+ tw: *i!c; ~ ~
                                                                                                                                  ph,trm,tc epoct,i(. a&ttrtp titrt'tkci                  tltt. PIN,

                                                                                                                                                                                                                              t ~t ~ + i

              1               General Comment section above.
                              Remove the note from the "Colour and Clarity" box. We would encourage that both thesc tests be           Colour and Clarity
                              harmonized as part of the PDG Process.                                                              tl>cri(;.ki . ~ ~ . ~ . 7 ~ v c .,..j.l..jkpy1b.c~c,,> c~~,;o.~~,L,F.'..~.+
                                                                                                                                                                     , r ~ , c ~... ~
                              The title andlor introductory paragraph of Attachment I1 should indicatc that this is an example of W X i Document Submission Provided for ICH 4 4 8 EWG Evaluat~onlix.
                   12-' l 8
                              how the process would work using PDG as indicated in lines 54-55 of this document.                  I lar~not~r/cJl ~ a r ~ ~ . ~ ~ c':csr ~ ; r i
                                                                                                                                                    I'                              opi                                                         I

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