ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To lay down a procedure for Analyst’s validation

2.0 SCOPE: 

This procedure is applicable to Analytical chemists’ validation, the persons who analyze the sample on chemical and instrumentations in Quality control department.

5.0 PROCEDURE:

5.1 All the quality control chemists need to be trained and qualified for handling of instruments & testing of samples.

5.2 Training shall be given to all quality control chemists for operation of instruments and good laboratory practices.

5.3 All respective chemists shall perform the testing as per standard test procedures of the samples in triplicates with three different weights on any of the instruments or methods given below and it shall be recorded in raw data sheets.

5.3.1 Assay by HPLC

5.3.2 Water content by KF

5.3.3 Assay by UV/VIS spectrophotometer.

5.3.4 SOR by Polarimeter.

5.3.5 Results of the three sets of one sample has been (prior to approval) tested by individual chemist should comply the acceptance criteria as given in table-1

5.4 Tested sample should comply with specification.

5.5 Qualified analysts shall be certified to perform the test.

5.6 The analyst’s validation shall be carried out once in three years.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To provide an Instruction for calibration of Instruments and Equipment.

2.0 SCOPE: 

This SOP is applicable to equipment in quality control laboratory.

5.0 PROCEDURE:

5.1 Calibration:

5.1 Log manually in register and issue work sheet to the Performer

5.2 Allot the A.R No. to each calibration (excluding daily performance check and external calibration) and enter calibration details in the calibration entry register.

5.3 In case calibration need to be performed by external organize the same.

5.4 Perform calibration for Instruments/Equipment’s as per the date given in master Calibration Plan. Record all data in relevant data sheets /forms /logbook as applicable

5.5 Perform the Instrument/Equipment calibration as per respective SOP and complete the documentation.

5.6 Record all data in relevant data sheets /forms /logbook as applicable

5.7 Record calibration details in the calibration summary report

5.8 Review the calibration report 

5.9 Release the instrument for regular use.

5.10 Affix the calibration status label

5.11 Update master calibration plan after completion of all calibrations for a given month, and get checked by Head QC.

5.12 If calibration fails, record the details in Instrument/ Equipment history cards and affix out of calibration label and inform Head QC

5.13 Investigate the Out of calibration results and in case of obvious errors arrange recalibration after eliminating errors.

5.14 In case of HPLC, Investigate the Out of Calibration results as mentioned in checklist and in case of obvious errors arrange recalibration after eliminating errors.

5.15 In case no obvious errors observed initiate deviation and arrange service by relevant service providers.

5.16 Organize recalibration or partial recalibration after rectification of the error (Wherever applicable obtain inputs from service provider.) For e.g., If Detector lamp is changed in HPLC, Perform detector response linearity, detector Noise and drift test.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To provide a procedure for monitoring of temperature and humidity in Quality Control laboratory areas.

2.0 SCOPE: 

This SOP is applicable to Quality Control laboratory.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To lay down a procedure for operating Water Purification System

2.0 SCOPE: 

This Procedure applies to operation of Water Purification System used in Quality Control laboratory.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To lay down a procedure for Cleaning of Sampler and Sampling Devices.

2.0 SCOPE: 

This procedure is applicable to cleaning of sampler and sampling devices, which is used for sampling of Raw materials and in-process samples. 

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To lay down a procedure for operating & calibration of Ultra-Violet cabinet

2.0 SCOPE: 

This procedure is applicable to operating & calibration of Ultra-Violet cabinet.

5.0 PROCEDURE:

5.1  Operation

5.1.1 Ensure that instrument is clean and free from dust.

5.1.2 Switch on the mains.

 5.1.3 Place the developed TLC plate in the chamber

5.1.4 Close the Chamber.

5.1.5 Select the desired wavelength by switching on the respective lamp (254nm, 365nm).

5.1.6 Observe the developed plate through the eye viewer.

5.1.7 Switch ‘OFF’ the illuminating lamp before removing the plate

5.1.8 Record the details in the instrument log book for results & breakdown.

5.2 Calibration

5.2.1 Prepare 0.2 % w/v solution of sodium salicylate in 95 % ethanol (for 365nm) and 0.04 % solution of sodium salicylate (for 254 nm) in 95 % ethanol.

5.2.2  Apply both conc. (5 ml) on plate coated with silica gel G.

5.2.3 Operate the instrument as per operating procedure.

5.2.4 Examine the spot in position normal to radiation.

5.2.5 The lamp should be capable of revealing without doubt a standard spot of sodium salicylate with a Diameter of about 5 mm on a chromatographic plate coated with Silica gel G.

5.2.6 Frequency for Calibration – Half yearly.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To provide an instruction for operation and calibration of Analytical Balance.

2.0 SCOPE: 

This procedure is applicable to the operation and calibration of the analytical balance in the Quality Control Department.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To lay down procedure for operation and calibration of Friability test apparatus.

2.0 SCOPE: 

This procedure is applicable to the friability test apparatus used in Quality Control Laboratory

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To lay down procedure for operation and calibration of Centrifuge.

2.0 SCOPE: 

This procedure is applicable to the centrifuge used in Quality Control laboratory

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To lay down a procedure for operation and calibration of Digital Polarimeter.

2.0 SCOPE: 

This procedure is applicable for operation and calibration of Digital Polarimeter in the Quality control department.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download