Sampling of Raw Materials

1.0      PURPOSE:  To ensure the smooth sampling of raw materials. It is important that the Sampling is done in an appropriate manner so that a representative sample is taken. 2.0      SCOPE:  Any materials related to manufacturing which is entering the warehouse, Must be sampled properly. 3.0      DEFINITIONS :  Nil 4.0      RESPONSIBILITY: QC officer 5.0      PROCEDURES: 5.1      After receipt of the material in the warehouse the store officer will send an Advice note to the QC department for sampling the material. The advice note Will contain in following information:             5.1.1        Name of the material 5.1.2        Name of the product 5.1.3        Country of origin 5.1.4        Control number of the product 5.1.5        Date of manufacturer 5.1.6        No. of containers received 5.1.7        Description of the containers received 5.1.8        Pack size of the containers.                    Sampling should be done in the following manner:                         5.2.1  Up to three containers        -       from one container                         5.2.2  From 4 to 5 containers       -       from 2 containers                         5.2.3  From 6 to 15 containers     -       from 3 containers                         5.2.4  From 16 to above               -       from every 5th container

Sample should be collected in inert container so that they do not react with the sample. For powdered materials samples should be taken with suitable sampling scoops made up of inert materials. For liquid this should be taken with glass sampling tubes. Suitable siphons may be used in case of sampling thick liquids. Amounts of sample taken should be at least twice the amount required for complete test.

Calibration of UV- VIS Detector for HPLC

1.0      PURPOSE:  To ensure smooth functioning of HPLC Machine. 2.0      SCOPE  :  The SOP applies to the calibration of UV-VIS detector of Shimadzu                          Company model No. SPD-10A vp. 3.0   DEFINITION:    Nil. 4.0 RESPONSBILITY:  Quality Control officer. 5.0  PROCEDURES: 5.1      Press & hold down the “shift” key & turn the power switch on. 5.2      Press the “func” key until lamp is displayed. 5.3      Press  “1”, then enter. 5.4      Press “func” until “Wave check” is displayed. 5.5      Press “enter”. The wavelength accuracy check is run automatically. CHECK GOOD should appear on the screen when the test ends.

Calibration of Spectrophotometer

1.0   PURPOSE:   To ensure smooth functioning of Spectrophotometer. 2.0   SCOPE   :   The SOP applies to the calibration of Spectrophotometer of Shimadzu                             Company model No. UV-1201 3.0   DEFINITION:  Nil. 4.0  RESPONSIBILITY :  QC officer. 5.0  PROCEDURE: 5.1  Switch on the machine & wait for auto calibration . 5.2  After auto calibration check the absorbance of potassium Dichromate Solution VS at the wavelengths indicated in the following table which gives for each Wavelength the exact value of A (1% 1cm) & the permitted limits. The tolerance of absorbance is ± 0.01           Wavelength (nm)                     A(1% 1cm)                     Maximum Tolerance                     235                        -                124.5           -                  122.9 – 126.2                  257                        -                 144.0           -                  142.4 – 145.2                  315                        -                 48.6            -                    47.0 – 50.3                  350                        -                 106.6           -                   104.9 – 108.2

Calibration of pH Meter

1.0      Purpose:  To ensure smooth running of PH meter with desired accuracy. 2.0   Scope    :   This SOP applies to the calibration of PH meter. 3.0   Definitions:  Nil 4.0      Responsibility:  QC officer. 5.0   Procedures    : 5.1          Place buffer 4.0 or 7.0 in the vessel & press CAL / MEANS after switching on the Machine. 5.2          Press CON button & enter the value selected for Calibration & record the reading. 5.3          The electrode of PH meter is immersed in the buffer solution of PH 4.0 & adjusting The meter to the appropriate PH value. Ref. BP-93  APPENDIX VM (Table-2) How to use the PH meter: 1)      Press the button CAL / MEANS 2)      Select the next higher PH buffer setting in the PH calibration mode. 3)      Select the next lower PH buffer setting in the PH calibration mode. 4)      Press CON button & enter the value selected for calibration.