Tuesday, November 30, 2010

Instruction For Analytical Report Numbering Procedure (AR No.)

1.0     Purpose   :      To provide an instruction for analytical report numbering procedure (AR No.)

2.0    Objective  :      To provide a documented procedure for analytical report numbering.

3.0      Scope      :    This procedure is applicable for analytical report numbering in QC department  ---Pharmaceuticals Ltd,
    4.0    Responsibility  :
·        Primary     :   QC Chemist / QC-Officer
·        Secondary  :   Overall: QC-Officer

5.0     Procedure:
·        Analytical Report Numbering for Raw Material
Ø      Numbering of analytical report of raw material shall be in the form of R-XXX/YY/ZZ
          For Raw material: R-XXX/YY/ZZ(e.g. R-001/09/09)

              Where,   R          = raw material

                    XXX            = serial no. (e.g. 001, 002,)
                      YY             =month.
                      ZZ            = year (e.g. 2009 as 09)

·        Analytical Report Numbering for Packing Material
Ø      Numbering of analytical report of packing material shall be in the form of P-XXX/YY/ZZ.
          For Packing material: P-XXX/YY/ZZ (e.g. P-001/08/09)
              Where,   P          = packing material
                     XXX           = serial no. (e.g. 001, 002…)
                      YY             =  month.  (e.g.01,02..  )
                                          ZZ             =  year (e.g. 2009 as 09)

·               Analytical Report Numbering for Intermediate
Ø      Numbering of analytical report of intermediate shall be in the form of
      I-WWW/XXX/YY/ZZ.
          For Intermediate: I- WWW/XXX/YY/ZZ (e.g. I-001/001/01/09)
             Where,           I      =  Intermediate
                            WWW   =   product code (001, 002, ….)
                             XXX    =   serial no. (e.g. 001, 002, ….)
                               Y Y    =   month. (e.g.01,02..  )
                               ZZ     =    year (e.g. 2009 as 09)

·               Analytical Report Numbering for Finished Product
Ø      Numbering of analytical report of finished product shall be in the form of XXX or WWW or WW//XXX/YY/ZZ
          For Finished product:   WWW or WW/XXX/YY/ZZ  (e.g.  MBZ/001/01/09)
          Where,            WWW or WW       = Short name of product (001, 002, ….)
                                      XXX                  = serial no. (e.g. 001, 002, ….)
                                                             YY              =  month (e.g.01,02..  )
                                                 ZZ              =  year (e.g. 2009 as 09)

·               Analytical Report Numbering for Re-testing Raw Material
Ø      Numbering of analytical report of re-test raw material shall be in the form of                        R-XXX/ZZ/R1.
          For re-test Raw material: R-XXX/ZZ/R1 (e.g. R-001/09/R1)
          Where,       R          = raw material
                       XXX         = serial no. (e.g. 001, 002, ….)
                         ZZ           = year (e.g. 2009 as 09)
                                              R1          = re-test first time (e.g. R1, R2, ….)

·               Analytical Report Numbering for Re-testing Intermediate
Ø      Numbering of analytical report of re-test intermediate shall be in the form of                        I- WWW/XXX /ZZ/I1
          For Intermediate: I- WWW/XXX/ZZ/I1 (e.g. I-001/001/09/I1)
           Where,         I        = intermediate
                          WWW   = product code (001, 002, ….)
                          XXX      = serial no. (e.g. 001, 002, ….)
                             ZZ       = year (e.g. 2009as 09)
                                              I1           = re-test first time ( e.g. I1, I2, ….)

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