SOP operation and calibration of melting point apparatus 

SOP operation and calibration of melting point apparatus.   OBJECTIVE: To ensure that there is a standard procedure followed for Operating & Calibrating the Melting point Apparatus to ensure efficient working of the instrument.   SCOPE: Operation & Calibration of Melting point Apparatus for checking Melting Point / Boiling point of raw Materials / Finished … Read more

Operation and Calibration of  HPLC Shimadzu(2010CHT)

Operation and Calibration of  HPLC Shimadzu(2010CHT)   1.0       OBJECTIVE:To establish the procedure for operation and calibration of high performance liquid chromatography to maintain the instrument in a good working condition and to ensure getting correct and precise results.   2.0              SCOPE:Applicable to HPLC SYSTEM.     3.0       RESPONSIBILITY:Quality Control Chemist/Officer/ shall perform the Analysis … Read more

Operation and Maintainance of Aquapuri water system.

Operation and Maintainance of Aquapuri water system.     OBJECTIVE: To lay down a procedure for Operation of Aquapuri Water Purification System     SCOPE: This SOP is applicable in Quality Control for operation of Aquapuri water purification system.     RESPONSIBILITY: QC Executive/Officer – To follow the SOP Technical manager – To ensure proper … Read more

SOP preparation of reagents & indicators.

SOP preparation of reagents & indicators.   OBJECTIVE:To lay down a procedure for preparation of reagents and indicators.   SCOPE:This procedure is applicable for procedure for preparation of reagents and indicators.   3.0        RESPONSIBILITY:         QC – officers, executives: shall be responsible following this SOP Technical Manager shall be responsible for Checking and approving. … Read more

SOP Column performance and its report.

SOP Column performance and its report. OBJECTIVE    To lay down the procedure for handling, storage, maintenance, verification and disposal of chromatographic column.     SCOPE:This SOP is applicable for handling, storage, maintenance, verification and disposal of    chromatographic column in QC Department.     Procedure: Ensure that the column is properly packed and in well … Read more

Operation and calibration of water bath

SOP: Operation and calibration of water bath.     OBJECTIVE: To ensure that there is standard procedures followed for Operation and calibration of Thermostatic Controlled Water Bath and ensure efficient working of the instrument.   SCOPE: This procedure is applicable for operation and calibration of Thermostatic Controlled Water Bath in Qc department. REFERENCE: Instrument manual … Read more

CALIBRATION OF INSTRUMENTS

SOP CALIBRATION OF INSTRUMENTS   OBJECTIVE : To define the procedure for calibration of the Laboratory Instruments to check the accuracy and reproducibility of the results.   SCOPE: This procedure is applicable for Calibration of Laboratory Instruments to check the accuracy. REFERENCES: i) Instrument Manual. ii) Pharmacopeia iii) In-House. RESPONSIBILITY: QC – officers, executives – … Read more

SOP of good laboratory practices (GLP)

SOP of good laboratory practices (GLP)   Objective:To avoid any error or mistake during performance of analysis.   Scope: This SOP provoids guideline for GLP   Responsibility: Quality control Manager Quality control Officer   Procedure: While performing any analysis always follows respective SOP. Use only pure (AR/GR grade) material for standardization. Use calibrated volumetric glassware … Read more

PREPARATION OF SPECIFICATIONS

PREPARATION OF SPECIFICATIONS   OBJECTIVE: To describe in detail the requirements of the specifications of Finished products / Raw materials / Intermediates / In process / Packaging material / Primary standard. SCOPE: This procedure applies to all finished products / Intermediates / Raw materials In process sample and packaging material / Primary standard. REFERENCE: In … Read more

OPERATION AND CALIBRATION OF KARL-FISCHER TITRATOR

OPERATION AND CALIBRATION OF KARL-FISCHER TITRATOR   Objective: To ensure that there is a standard procedure followed for operating Karl-Fischer titrator; ensuring efficient working of the instrument.   Scope: Estimation of water content in raw materials and finished products   Responsibility: Quality control chemist Quality control-manager Quality assurance manager   Steps of operation:   At first clean … Read more

SOP:Operation and calibration of disintegration test apparatus.

SOP:Operation and calibration of disintegration test apparatus.   OBJECTIVE:To ensure that there is a standard procedure followed for operating disintegration apparatus and ensuring efficient working of the instrument.   SCOPE:To test disintegration time of capsules and tablets.   RESPONSIBILITY:QC – officers, executives –  To follow the procedure as per SOP.QC Head –  To ensure proper … Read more