Responsibilities of the Quality Assurance Department OBJECTIVE : To lay down the responsibilities of the Quality Assurance Department. RESPONSIBILITY : All personnel of the Quality Assurance Department. Head of Quality Assurance Department to ensure compliance. PROCEDURE : The Quality Assurance department shall be responsible to formulate systems for the implementation of cGMP and, to ensure … Read more
Procedure for calibration of HPLC (WATERS ALLIANCES) 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 products. As technology continues to advance, HPLC … Read more
OBJECTIVE To lay down the procedure for operation of Fourier Transform Infrared Spectro-photometer (Shimadzu) SCOPE This SOP shall be applicable for Quality Control in Quality Assurance department. RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched ‘ OFF ‘ before cleaning. Clean the … Read more
Collection, Storage, and Control of Reserve Samples for Drug Products OBJECTIVE : To lay down a procedure for collection, storage, retrieval, and disposition of reserve samples of drug products. RESPONSIBILITY : Quality Assurance Officer for collection, storage, retrieval, and disposal of reserve samples. Head of Quality Assurance Department to ensure compliance. PROCEDURE : Every batch/lot … Read more
OBJECTIVE : To provide a procedure for correction of any documentation error, occurred during documenting data in operating departments (like Quality Control, Production, Warehouse, Engineering, QA) RESPONSIBILITY : Personnel of concerned department to implement. Heads of concerned departments to ensure compliance. PROCEDURE : All personnel shall avoid making data entry errors. In case an entry … Read more
OBJECTIVE : To lay down the procedure for in-process checks during the packaging operation of tablets and capsules. RESPONSIBILITY : Officer-Production Packaging. Head of Production Department. Officer-Quality Assurance Head of Quality Assurance Department to ensure compliance. PROCEDURE Inspection of Packaging Materials : The production Officer and QA-Officer shall check that the packaging components issued (containers, … Read more
Installation qualification for WFI generation plant RESPONSIBILITES Inspection Customer or their authorized representatives are responsible for this SAT document. All documents shall be checked and approved by QA or their authorized representatives. Production personal will perform this test. OBJECTIVE To confirm, by physical inspection and testing, that the fabrication and assembly of the equipment and … Read more
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 products. As technology continues to … Read more
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 touch screen display terminal having … Read more
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 and instrument cleanliness. Connect the … Read more
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 Control. ACCOUNTABILITY Head QC/QA. PROCEDURE … Read more
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 shall be calibrated. There shall … Read more
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 System. To document the observations … Read more
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 caters to:- AREA DETAILS Sr. … Read more
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 of the section footwears is … Read more
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. Abbreviations SOP : Standard Operating … Read more
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. Procedure Controlled Area Operation. Load … Read more
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 NST : Non sterile side … Read more
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 of SOP. Abbreviations SOP : … Read more
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 Operating Procedure. WFI : Water … Read more