SOP on Operating procedure for disintegration test apparatus in Pharmaceutical company OBJECTIVE To lay down a procedure for Operation of Tablet Disintegration Tester (Make –Electrolab Model- ED2AL). SCOPE This Standard Operating Procedure (SOP) is applicable to test the disintegration time of the tablets during in process/ QC samples analysis. RESPONSIBILITY …

OBJECTIVE To lay down a procedure for Operation of Friability Test Apparatus (Make – Electrolab Model-EF2) SCOPE This Standard Operating Procedure (SOP) is applicable to check the friability of In-process samples/QC samples. RESPONSIBILITY IPQA / QC/Production Executive / Officer ACCOUNTABILITY Head –Quality Assurance PROCEDURE Clean the apparatus free of dust …

OBJECTIVE To lay down a procedure for Operation of Halogen Moisture Balance SCOPE This Standard Operating Procedure (SOP) is applicable to In-process samples. RESPONSIBILITY IPQA / Production Executive / Officer  ACCOUNTABILITY Head–Quality Assurance PROCEDURE Switch on the mains. Check the level of the instrument by checking the air bubble in …

OBJECTIVE To lay down a procedure for Operation of Leak Test Apparatus SCOPE This Standard Operating Procedure (SOP) is applicable to In-process samples. RESPONSIBILITY IPQA / Production Executive / Officer ACCOUNTABILITY Head –Quality Assurance PROCEDURE Ensure that the leak test apparatus is clean. Check that the desiccator is clean, if …

OBJECTIVE To lay down a procedure for Operation of Vernier Caliper SCOPE This Standard Operating Procedure (SOP) is applicable to In-process samples. RESPONSIBILITY IPQA / Production Executive / Officer ACCOUNTABILITY Head –Quality Assurance PROCEDURE CLEANING Clean the apparatus with tissue paper after every use. OPERATING  INSTRUCTIONS  : Press the ON/OFF …

SOP on Procedure for the operation of HPLC (waters-alliance) In the pharmaceutical industry, where precision and accuracy are non-negotiable, High-Performance Liquid Chromatography stands as a stalwart technology. From drug development to quality control and regulatory compliance, HPLC plays a vital role in ensuring the safety, efficacy, and consistency of pharmaceutical …

OBJECTIVE To lay down a procedure for operating and cleaning of analytical balance) SCOPE This SOP shall provide the Operating procedure of analytical balance of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE Description of balance: XS 204 DR is analytical class balance with a …

OBJECTIVE To lay down the procedure for Operation of Tap density apparatus, Make Electro lab. SCOPE This SOP shall provide the Operating procedure of Tap density apparatus of quality control department. RESPONSIBILITY Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE Before starting the operation Check for the area cleanliness …

SOP on Operating procedure for sieve shaker in quality control To lay down the procedure for the Operation of the Mechanical Sieve Shaker, Make an Electro Lab. SCOPE OF SOP This SOP shall provide the Operating procedure of Mechanical Sieve Shaker of quality control department. RESPONSIBILITY Officer/ Executive – Quality …

OBJECTIVE : To lay down policy for calibration of Instruments/Equipments. RESPONSIBILITY : Personnel of the concerned department to calibrate the instrument/equipment and investigate the failure, if any. Heads of the  concerned department to ensure compliance. Procedure : All the instruments associated with the processing and testing of materials and products …

Operation qualification protocol for air handling unit & air distribution system Purpose: The purpose of this protocol is: To verify the operational attributes of the Heating Ventilation and Air Conditioning system, critical to serve the intended purpose. To establish the suitability of the draft SOP prepared for the operation of …

Installation qualification protocol for air handling unit & air distribution system OBJECTIVE The objective of this protocol is to provide an outline for the inspection of static attributes, written procedure and  guidelines and respective acceptance criteria for the Installation and Operational Qualification of Air handling unit . The Air-Handling unit …

Objective The SOP describes cleaning procedure for footwear used in production area. Scope This SOP is applicable for the cleaning procedure for footwear used in production area. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations IPA  :  Isopropyl alcohol Description Cleaning …

Objective To lay down the procedure for operation, cleaning and maintenance of Fogger. Scope This SOP is applicable for the operation, cleaning and maintenance of Fogger used in the Aseptic area of Sterile Injectable Facility. Responsibility Production officer / Executive. Accountability Production Head shall be accountable for compliance of SOP. …

Objective: To lay down a procedure for sterilization of vial filling and bunging machine parts. Scope This SOP is applicable for sterilization of vial filling and bunging machine parts. Responsibility Production Officers/ Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. …

Objective: To lay down a procedure for operation of vacuum leak test Scope: This SOP is applicable for operation of vacuum leak test. Responsibility: Production Officers / Executive. Accountability: Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure MMI : Man Machine Interface …

Objective: To lay down a procedure for cleaning of the pre-filters of LAF Unit, garment cubicle, dynamic pass box. Scope This SOP is applicable for cleaning of pre-filters of LAF Unit, garment cubicle, dynamic pass box. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance …

Objective: To lay down a procedure for Disposal of rejected primary & secondary packing materials. Scope This SOP is applicable on procedure for Disposal of rejected primary & secondary packing materials for Production dry powder Injection facility. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard …

OBJECTIVE :      To lay down the procedure for Installation, Operation and Performance qualification of Equipment. RESPONSIBILITY :             Validation team comprising of representatives from functional department,   Engineering department and Quality Assurance department. Head – QA, Head – Engineering and Head of the concerned department to ensure compliance. PROCEDURE    Any …

Preparation, Approval and Control of Standard Cleaning Procedures for equipments OBJECTIVE :             To  lay  down  the  guidelines  for  the  preparation,  approval and control of Standard Cleaning  Procedure (SCP) for all the applicable equipments. RESPONSIBILITY :     All the personnel  involved in the cleaning of equipments. Heads of concerned departments to ensure …