Instruction For Inspection Of Control Sample

1.0         Purpose   :    To provide an instruction for inspection of control sample.

2.0         Objective  :      To provide a documented procedure for inspection of control sample.

3.0               Scope        :      This procedure is applicable for inspection of control sample in QC laboratory ----Pharmaceuticals Ltd.

4.0         Responsibility  :

·       Primary: QC Chemist / QC Officer

·       Secondary : Overall: QC – Incharge

5.0       Procedure   :

·       Take entry of all the products batch wise manufactured; in the Control sample observation logbook after QC release.

·       Keep the samples in Control sample as per standard procedure of control sample.

·       The QC Chemist should check control samples randomly by visually at a frequency of every 12 months form the kept on date entry.

·       QC chemist shall carry out the visual test for description of product as mentioned in specification of the relevant product.

·       If any abnormalities observed in any product and batch, inform to the QC In-charge immediately, and record it accordingly.

·       If found satisfactory than mentioned ‘found satisfactory” remark in the Control Sample Inspection logbook.

6.0      Reference Document:

v      Control Sample logbook

Product: ___________________________               Product Code: ____________________

 

Sr.No	Year	Batch No.	Date of mfg.	Date of exp.	Kept on	Frequency 12 months	Observation	Date of observation	Checked by

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, ….)

Role Of Quality Control Department In Rejection

1.0         Purpose    :  To provide an instruction for role of quality control department in rejection.

2.0         Objective  :  To provide a documented procedure for role of quality control department in rejection.

3.0          Scope     :   This procedure is applicable for role of quality control department in rejection ----- Pharmaceuticals Ltd,

4.0         Responsibility  :

·        Primary      :  QC Chemist / QC-Officer

·         Secondary :  Overall: QC – In charge

5.0       Procedure   :

·        QC Chemist when comes across any non-conformance, he himself cross checks the finding.

·        The findings are again verified by QC In charge.

·        Upon confirmation he informs to QA and fills OOS and follows OOS procedure.

·        After the study of OOS, QA person put remark on OOS (Reject /Approve.)

·        The QC Personnel prepares the rejection report, which is signed by Q.C. In-charge and is stamped as “Rejected” in “RED INK”.

·        The rejected labels are affixed on the containers of rejected material as rejected “RED INK” and these containers are segregated from the remaining stock under lock and key with restricted access.

6.0      Reference Document  :

v     Rejection Record.

Sr No.	Date	Name of Material/ Product.	AR. No.	B. No	Qty.	Reason for Rejection	Rejected  by	Approved by.
Format:-F/QC/014