Home / QA & QC / Other Topic

Other Topic

The role of dissolution in drug development

The role of dissolution in drug development Oral dosage forms remain one of the most flexible and effective treatments available to patients. Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing. It is a pivotal …

Read More »

Types of Glass used in Pharmaceutical Industries

Types of Glass used in Pharmaceutical Industries Parenteral Use Type I Glass: Highly Resistant Borosillicate. Used for Buffered and Unbuffered aqueous solution.Type II Glas: Highly Resistant Sodalime glass. Buffered aqueous solution below pH 7.0Type III Glass: Moderately Resistant Sodalime glass. Used for dry powder and oily solution.Non-Parenteral Use Type IV …

Read More »

RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST

RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST Material Name: AR No./MRR No./ Date: SNo. Description Check Point 1 Environmental Conditions Temperature RH 2 Under test label Affixed / Not affixed 3 Packing Packed in carboys / drums Packed in fiber/plastic drums with polybag inside Packed in PP woven …

Read More »

Qualification For Walk In Chamber ( STABILITY DATA ACQUSITION SOFTWARE)

Qualification For Walk In Chamber ( STABILITY DATA ACQUSITION SOFTWARE) Introduction Purpose The purpose of this Qualification Plan (QP) is to define the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Testing activities for the qualification of WALK IN CHAMBER, STABILITY DATA ACQUSITION SOFTWARE to be deployed at Quality …

Read More »

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM INDEX PART –I                                                                                                 Page no. Objective Brief Description Purpose Procedure Acceptance criteria PART –II Data generation for viable count PART –III Summary Recommendation Attachments PART-I  1.0          OBJECTIVE The objective of this study is to determine the efficacy of  …

Read More »

VALIDATION MASTER PLAN

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 …

Read More »

Types of liquid column chromatography ( HPLC),HPLC Separation and HPLC Silica gel

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 …

Read More »

Deviation Handling and Quality Risk Management (Part – I)

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 effective and timely implementation of tools related to deviation management encountered …

Read More »

Master Plan or Protocol for Process Capability Design and Testing

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 …

Read More »

QUALITY BY DESIGN (QBD) IN PHAARMACEUTICAL PRODUCT

INTRODUCTION: The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design (QbD) is emerging to enhance the assurance of safe, effective drug supply …

Read More »