cGMP and Regulatory Updates

1.0. PURPOSE : To provide a procedure for the operation of Karl Fisher titrator. 2.0. SCOPE : Applicable to Karl Fisher titrator. MAKE & MODEL : Lasco, KFTA. 3.0. RESPONSIBILITY: 3.1. Officer-Quality Control 3.2. Executive-Quality Control 4.0. ACCOUNTABILITY: Manager-Quality Control 5.0. DEFINITION: Nil 6.0. PROCEDURE: 6.1. Ensure the calibration status is valid. 6.2. Ensure the instrument is clean and free from dust. 6.3. Switch on the instrument by using switch provided on rear side of left. Green LED ‘O’ will glow. 6.4. Fix KFR bottle by screwing on the plastic cap, operate bellow, holding vertically and closing the “T” joint connection tube. Air pressure in KFR bottle increases and lifts KFR to fill burette, when level crosses ‘0’ mark remove finger, Zero level gets automatically. 6.5. Place magnetic stirring paddle slowly by sliding in to the reaction vessel and fix the burette by lifting the burette by lifting the burette assembly. 6.6. Pour about 20ml of methanol into t...

1.0 PROCEDURE : For control of absorbances. 1.1 Preparation of Potassium dichromate solution. 1.2 Dry Potassium dichromate at 130°C for 2 hours. Weigh accurately about 60mg of potassium dichromate into 1000ml volumetric flask. Add 0.005 M sulfuric acid to dissolve and dilute with same solvent. 1.3 Calibration : Using the Wave lengths. 235 nm 313 nm 257 nm 350 nm Find out the absorbance of a A(1% cm). Calculate the A(1% cm) value as per the formula for each wavelengths. Check the value for each wavelengths with tolerances given for all four wavelengths Tolerances (ie) 2.0 PROCEDURE : For Limit of stray light 2.1 Preparation of 1.2% w/v of Potassium chloride solution. 2.2 Dry Potassium chloride at 105C for 2 hours. Weigh accurately about 1.2 g of potassium chloride into 100 ml volumetric flask. Add water to dissolve and dilute with the same solvent. 2.3 Calibration : Stray light detected at a wavelength at 200 nm Find out the absorbance at 200 nm with tolerance should be greater than 2....

1.0 CONTROL OF ABSORBANCES PROCEDURE: REPARATION OF POTASSIUM DICROMATE SOLUTION: Dry K2Cr2O7 at 130oC for 2 hours. Weigh accurately about the quantity of sample equal to 60mg into 1000ml volumetric flask. Add 0.005m Sulphuric acid to dissolve and dilute with the same solvent. Find out the absorbances of (A 1% 1cm) above said solution at wavelengths of a 235nm, 257nm, 313nm and 350nm. Calculate the (1% 1cm) value using the following expression. Absorbance X 1 X 1000 / Weight of K2Cr2O7 in g X 100 Check the value for each wavelength with the tolerances given four wavelengths. PREPARATION OF REAGENT: (i) Dilute 3ml of concentrated sulphuric acid and make up 100ml with distilled water. (ii) Dilute 20ml to 2000ml with distilled water. 2. LIMIT OF STRAYLIGHT: The absorbance of a 1.2-% w/v solution of potassium chloride at a path-length of 1cm should be greater than 2.0 at about 200nm when compared with water as reference liquid. 1.2% POTASSIUM CHLORIDE SOLUTION: Take 1.2 g of Potassium chlo...

1.0 PROCEDURE 1.1 First set zero point as follows a) Loosen the fixing screw b) Allow the rotor to rotate in air c) The cover is twisted so that the reference mark on the sight glass is lined up with the zero point of the scale reading. d) Cover is secured by tightening the screw 1.2 Fix the temperature vessel and suitable spindle to the basic instrument. 1.3 The Cup (Stator) is fixed to the instrument and filled with standard liquid paraffin (whose viscosity is known) paying attention to the filling mark. 1.4 Set the speed stage 4,8,16 and note the resulting scale values. 1.5 Repeat the operation once more. 2.0 DOCUMENTATION 2.1 F:Sxxxx/VCR - Viscometer Calibration Record.

1.0. PURPOSE : To validate the water System by providing a procedure for Sampling & analysis of water. 2.0. SCOPE : Applicable for DM water (Purified Water) and Raw Water. 3.0. RESPONSIBILITY : Quality Control Chemist / officer. 4.0. PROCEDURE : 4.1 MICROBIAL ANALYSIS: 4.1.1 Microbial Analysis of water is carried out as per table 4.12 4.1.2 Frequency, Method and Limit of Microbial Analysis 4.1.3 Collect about 200ml of sample at the point of supply in a pre sterilised clean glass bottle & proceed for microbial analysis within 30 minutes of sampling. 4.1.4 Incase the sample is found above the alert limit for microbial count the cleaning and sanitation of DM plant, overhead tank as the case may be is carried out. After sanitation the equipment is repeatedly flushed with hot water and revalidated. 4.2 CHEMICAL ANALYSIS: 4.2.1 The chemical Analysis of water is carried out as per the table 4.2.2 4.2.2 Frequency, Method and chemical analysis of water. 4.2.3 Collect the sample at the ...

1.0 PURPOSE : To provide a procedure for visual inspections of control samples 2.0 SCOPE : To inspect the control sample by visual means. 3.0 RESPONSIBILITY : QC Chemist and QC Manager. 4.0 PROCEDURE 4.1 :All the control samples, of tablets, powder and liquid products kept in control sample room shall be checked visually. 4.2 : The sample shall be checked once in 6 months. 4.3 : The sample shall be checked for the following parameters i) Appearance of the tablets, powder and liquid. ii) Colour change in any iii) Solidification or sedimentation in case of liquids. 4.4 : The observations are to be recorded in visual inspection report. 4.5 : Incase of discrepancies the report should be forwarded to QA and production to take further action.

1.0 PURPOSE : To provide a procedure for operation of Air sampler 2.0 SCOPE : The procedure covers the relevant method for the operation of the slit Air sampler 3.0 RESPONSIBILITY : Microbiologist 4.0 PROCEDURE : Preparation of Agar media strip: Media composition and preparation refer SOP No. QC/MB/04/1.3. Under aseptic conditions (LAF) pour the media using sterilized pipettes into the pre-sterilized empty strips. Allow the media to solidify and then put back the strips into their respective wrappers. Incubate the strips for 24 hour & check for free from contamination. For Bacteria use Soyabean Casein digest Agar Strips For fungi use Sabouraud Chloroamphenicol Agar Strips Carry the air sampler and prepared media strips to the respective departments. Follow the gowning procedure as required by the respective department to avoid additional contamination. Disinfect the hands with 70% v/v IPA wear the sterile surgical gloves. 4.1 Fix the sterilized impeller cup and the impeller to the ...