Month: February 2022

SOP on Document Management System in Quality Assurance Department.

Posted on By Pharmaceutical Guidanace

Objective: To lay down a procedure for the Management of Documents in the Quality Assurance Department. Scope: Applicable for Document Management system in Quality Assurance department. Responsibility: Quality Assurance Department Accountability: Manager Q.A. is accountable for the compliance of this SOP. Procedure: Storage of Documents in Record Room. Documents shall be stored in the record…

Read More “SOP on Document Management System in Quality Assurance Department.” »

Quality Assurance

Sterilization Process Controls

Posted on By Abha Maurya

Sterilization Process Controls Inspectional Objectives Confirm that the sterilization process was validated by reviewing the validation study. Review the specific procedure(s) for the sterilization process selected and the methods for controlling and monitoring the process. Verify that the process is controlled and monitored. If review of the Device History Records (including process control and monitoring…

Read More “Sterilization Process Controls” »

Production

Dry Powder Injection

Posted on By Abha Maurya

Dry Powder Injection Majority of drugs show the problem of poor solubility, whether in the case of their analytical estimations or in the field of liquid dosage forms in the form of solutions. Commonly used organic solvents for spectrophotometric analysis of water insoluble drugs include methanol, ethanol, chloroform, benzene, dichloromethane, dimethyl formamide, acetonitrile, ethyl acetate,…

Read More “Dry Powder Injection” »

Production

EXPIRATION DATING AND STABILITY TESTING FOR HUMAN DRUG PRODUCTS

Posted on By Abha Maurya

EXPIRATION DATING AND STABILITY TESTING FOR HUMAN DRUG PRODUCTS Each drug product may be a unique article because of, for instance, differences in (1) chemical and physical properties of the active ingredients or the excipients, (2) manufacturing procedures, (3) formulations, (4) containers and closures, (5) proposed storage conditions, and (6) the stability of the article…

Read More “EXPIRATION DATING AND STABILITY TESTING FOR HUMAN DRUG PRODUCTS” »

Quality Assurance

DOCUMENTATION IN PHARMA

Posted on By Abha Maurya

DOCUMENTATION IN PHARMA Well-established documentation system exists to implement Good Documentation Practices, which is a part of Quality Assurance. Clearly written documents are prepared, reviewed and controlled, which prevents the errors from verbal communication and permits traceability for all activities carried out. Quality Assurance is responsible for the revision and distribution of documents and concerned…

Read More “DOCUMENTATION IN PHARMA” »

Quality Assurance

HEATING, VENTILATION AND AIR CONDITIONING (HVAC) SYSTEMS

Posted on By Abha Maurya

BRIEF DESCRIPTION OF HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) SYSTEMS: To avoid cross-contamination and to maintain relative humidity, temperature, and Pressure Difference of the manufacturing areas with Air handling Units, ­­­­­Air handling Units Provided in the manufacturing, warehouse, quality control, and microbiology section. Temperature and humidity are controlled and maintained within the limits as per…

Read More “HEATING, VENTILATION AND AIR CONDITIONING (HVAC) SYSTEMS” »

Engineering

BATCH MANUFACTURING RECORD OF DRY INJECTION

Posted on By Abha Maurya

BATCH MANUFACTURING RECORD OF DRY INJECTION Table of content Batch Details General Instructions Calculation of API Dispensing of raw material API transfer record Dispensing of primary packing materials Component preparation for sterilization Steam sterilization record Vial de-boxing, Staging, and Inspection record Vial washing record Vial depyrogenation record API Canister weight checking records Vial filling record…

Read More “BATCH MANUFACTURING RECORD OF DRY INJECTION” »

Production