QA & QC

STABILITY STUDY PROTOCOL THIS PROTOCOL IS: Lisinopril and Hydrochlorothiazide tablets 10+12.5 mg CONTENTS: Each uncoated tablet contains: Lisinopril dihydrate equivalent to Lisinopril 10mg Hydrochlorothiazide                                           12.5mg SHELF LIFE: 24 months DOSAGE FORM: Tablet MANUFACTURED AT: TYPE OF STABILITY STUDIES: Accelerated stability studies 40 + 20C / 75 + 5 …

Objective: To lay down the procedure for Transfer of Technology for Analytical Methods. Scope: This procedure is applicable for Transfer of technology for Analytical Methods from ARD to Formulation Unit. Responsibility: Responsibility of Sending Unit (ARD ) are : Preparation of Technology transfer Protocol for Analytical Method transfer. Execution of …

Disinfection Disinfection is a process that is designed to kill actively growing and vegetative microbial microorganisms to a certain level, and it does not, unless the disinfectant is classified as a sterilant, apply to bacterial endospores. Disinfection a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on …

SOP on Transfer of Technology for Manufacturing process Objective: To lay down the procedure for Transfer of Technology for Manufacturing Process. Scope: This procedure is applicable for Transfer of technology (i.e. for Manufacturing process) from sending unit (F R&D) to receiving site (Manufacturing facility ) Responsibility: Responsibility of Sending Unit …

Objective: To lay down the procedure for Fogging of Microbiology Testing Areas Scope: This SOP is applicable for Fogging of Microbiology Testing Areas in Microbiology Laboratory. Responsibility: Chemist or above of Microbiology Laboratory: Head – Microbiology section. Accountability: Head – Quality Control. Procedure: Operation Perform the Fogging of Microbiology once …

Objective: To lay down the cleaning & operating procedure of bursting strength tester. Scope: This SOP is applicable for the cleaning & operating procedure of bursting strength tester in quality control laboratory. Responsibilities: Chemist or above of QC laboratory in Packaging material Quality Control section is responsible for carrying out …

Objective: To lay down the procedure for Handling of Microbiological Data Deviation in Microbiology Laboratory. Scope: This procedure is applicable to environmental monitoring excursions (namely Passive air sampling, Active air sampling, Surface sampling, Personnel monitoring, and Compressed gas monitoring)obtained during the Environmental monitoring, Sterility testing, Bacterial Endotoxin Test, Bioburden, Microbial …

OOS in Microbiology Out-of-specification (OOS) occurrences pertain to situations where microbiological test outcomes deviate from predetermined acceptance criteria or specifications. These occurrences can arise due to a variety of factors, spanning from technical complications to procedural mistakes. The identification and resolution of OOS events play a crucial role in upholding …

Deviation Handling and Quality Risk Management This  guidance Based on WHO recommended requirements, these documents provide further explanations with examples in order to facilitate implementation. Deviation handling Quality Risk Management was mainly designed to be used prospectively when manufacturing operations are defined and validated. The potential deviations are identified and …

OBJECTIVE To lay down the procedure for Calibration of Tap density apparatus, Make – Electro lab. SCOPE This SOP shall provide the Calibration 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 …

OBJECTIVE To lay down the procedure for operation and calibration of Fourier Transform Infrared Spectrophotometer (Shimadzu) SCOPE This SOP shall be applicable for Quality Control in Quality Assurance department. RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched …

OBJECTIVE To lay down the procedure for calibration of pH / CONDUCTIVITY METER (PICO) SCOPE This Standard Operating Procedure (SOP) is applicable for pH meter (PICO).  RESPONSIBILITY Quality Control Executive / Officer. ACCOUNTABILITY Quality Control   Manager PROCEDURE Operate the Instrument as per procedure no.   BA(II)QA217 Calibrate the instrument by preparing …

OBJECTIVE To lay down the procedure for CALIBRATION of KARL FISCHER (METTLER TOLEDO) SCOPE To ensure that the instrument performs satisfactory and gives accurate and reproducible data. This SOP shall be applicable for the KARL FISCHER APPARATUS (METTLER TOLEDO). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager. PROCEDURE FOR CLEANING …

OBJECTIVE To lay down a procedure for Calibration of Friability Test Apparatus to give accurate and reproducible data. SCOPE This Standard Operating Procedure (SOP) is applicable to In process samples. RESPONSIBILITY IPQA / Production Executive / Officer  ACCOUNTABILITY Head–Quality Assurance PROCEDURE Operate the Friability test apparatus as per SOP No.  …

OBJECTIVE To lay down a procedure for Calibration of Disintegration test apparatus SCOPE This Standard Operating Procedure (SOP) is applicable to DT apparatus placed in IPQC lab and in Quality Control. RESPONSIBILITY IPQA / Production Executive / Officer  ACCOUNTABILITY Head–Quality Assurance PROCEDURE Check the water level in the water bath. …

OBJECTIVE To lay down a procedure for Operation of weighing balance PB-303S. SCOPE This Standard Operating Procedure (SOP) shall be applicable for weighing balances installed in sampling booth. RESPONSIBILITYQuality Control Officer / Executive ACCOUNTABILITY Head – Quality Assurance\ PROCEDURE On/off switching Press < IB> key briefly. The balance performs a …

OBJECTIVE To lay down the procedure for operation of pH / Conductivity meter (PICO) SCOPE To ensure that the instrument performs satisfactory and gives accurate and reproducible data. This SOP shall be applicable for the pH / Conductivity meter (PICO). RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Quality Control Manager. PROCEDURE PROCEDURE …

OBJECTIVE To lay down the procedure for Operation of Milli Q water system, Make Millipore. SCOPE  This SOP shall provide the Operating procedure of Milli – Q water system of quality control department. RESPONSIBILITY  Officer/ Executive – Quality Control ACCOUNTABILITY Head QC/QA PROCEDURE OPERATION OF ELIX –10 Switch on Elix …

OBJECTIVE To lay down a procedure for operation of SAS SUPER 100 Air sampler. SCOPE This SOP shall be applicable for viable air monitoring. RESPONSIBILITY Microbiologist ACCOUNTABILITY Head QC/QA PROCEDURE PRE START UP Remove the aspirating head. Insert an identified, closed contact plate and remove the lid of the plate. …

Humidity chamber The purpose of humidity chambers is to test the influence of varying environments on products to determine the length of their usefulness and at what point they will fail. The collected data assists engineers in adjusting their designs and selecting more resilient materials. Humidity chambers play a crucial …