QA & QC

Worst case identification for cleaning validation OBJECTIVE: Objective of this SOP is to provide the procedure to be followed during worst case identification for cleaning validation. It also includes updating of API solubility – potency matrix, calculation of acceptable residue levels during cleaning validation. SCOPE: This SOP covers the worst …

VALIDATION MASTER PLAN CONTENTS SR. NO. CONTENTS PAGE NO. 1 APPROVAL 2 INTRODUCTION 3 VALIDATION POLICY 4 OBJECTIVE 5 SCOPE 6 VALIDATION RESPONSIBILITIES 6.1 Validation Team Constitution 7 FACILITY DESCRIPTIONS AND DESIGN 7.1 General Description and Design Concept 7.2 Description of Products 7.3 Description of Process 7.4 Description of Equipments …

Management Review OBJECTIVE: To have a systematic approach for Management Review through meetings to review Quality Management System (QMS) with an objective to monitor product quality, products status and processes, identify improvements required in system, process and resources, review of quality risks throughout product life-cycle and to review if the …

OBJECTIVE: To lay down a procedure for temperature mapping in control rooms to determine the hot and cold spots.  SCOPE: This SOP is applicable to Control areas of  Pharmaceutical companies. RESPONSIBILITY: Officers and above of respective department shall be responsible for following the procedure.. The engineering department shall be responsible …

Types of liquid column chromatography ( HPLC),HPLC Separation and HPLC Silica gel Type of liquid column chromatography can be  to classify  on the based the nature of the stationary phase and the separation process, Can be classify  three type Adsorption chromatography Ion-exchange chromatography Size exclusion chromatography Adsorption chromatography In adsorption chromatography the stationary …

SOP for environmental  monitoring of air OBJECTIVE  :To lay down a procedure for environmental  monitoring of air. SCOPE  :This SOP shall provide the procedure for monitoring the viable air borne count . RESPONSIBILITY :Microbiologist ACCOUNTABILITY Manager QC/QA PROCEDURE  The microbial environmental conditions  shall be monitored as per defined frequency and …

  To lay down a procedure for calibration of Weighing Balance XS – 204 DR SCOPE This Standard Calibration Procedure (SOP) is applicable in quality control area. RESPONSIBILITY Quality Control Officer/ Executive ACCOUNTABILITY Head –Quality Assurance PROCEDURE PRE STARTUP Check the cleaning of the weighing balance especially pan & display …

Deviation Handling and Quality Risk Management Purpose The aim is to contribute to the understanding of a quality risk management approach in the handling of deviations from a practical perspective as per WHO expectations.  The intent is to support the effective and timely implementation of tools related to deviation management …

Question 1. What Is Cleaning Validation? Answer:   To evaluate the capability of cleaning procedure  in removing the drug residue and microbiological bio burden on equipment within established acceptance criteria, through the validation of cleaning procedures. To establish sufficient documented evidence to assure that, cleaning procedures can repeatedly and reproducibly remove …

Master Plan or Protocol for Process Capability Design and Testing Objective Process capability design and testing Types of process Batch, intermittent, continuous Typical processes Chemical, pharmaceutical, biochemical Process definition Flow diagram, in-process, finished product Definition of process output Potency, yield, physical parameters Definition of test methods Instrumentation, procedures, precision, and …