Process Validation Guidances: FDA and Global OUTLINE Process Validation Lifecycle Approach Overview History and development Is the lifecycle approach really new? FDA commentary Lifecy... Read more
New EU Requirements for Qualification & Validation
Posted By: Pharmaceutical Guidanaceon: In: Audit and Guideline, Other, Validation & QualificationNo Comments
Updated version of Annex 15 ◦ Qualification and Validation Draft released in February 2014 Final version released on the 30th of March , 2015 Will be effective on 01 October 2015 4/3/... Read more
Validation of Sterilization Process in Autoclave
Posted By: Pharmaceutical Guidanaceon: In: Other, Other Topic, Production, Uncategorized, Validation, Validation & QualificationNo Comments
Validation of Sterilization Process in Autoclave VALIDATION PROTOCOL Validation of Sterilization Process in Autoclave (Loaded chamber) Purpose : To provide the procedures... Read more
Qualification For Walk In Chamber ( STABILITY DATA ACQUSITION SOFTWARE)
Posted By: Pharmaceutical Guidanaceon: In: Other, Other Topic, QA & QC, Validation & QualificationNo Comments
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), Ope... Read more
DISINFECTANT VALIDATION
Posted By: Pharmaceutical Guidanaceon: In: Microbiology, Other, QA & QC, Validation & QualificationNo Comments
DISINFECTANT VALIDATION TABLE OF CONTENTS Section No Topics Page No 1.0 Protocol Approval 2.0 Objective 3.0 Acceptance Criteria 4.0 Responsibilities 5.0 Validation Methodologies 6.0 Evaluat... Read more
PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM
Posted By: Pharmaceutical Guidanaceon: In: Microbiology, Other, Other Topic, QA & QC, Validation & QualificationNo Comments
PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM INDEX PART –I Pag... Read more
DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS)
Posted By: Pharmaceutical Guidanaceon: In: Other, Qualification, Validation & QualificationNo Comments
DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS) TABLE OF CONTENT Objective Scope Responsibility Machine description Technical specification Technical specifications and make of su... Read more
Design Qualification of Pre-treatment & Purified Water Generation System Read more
Factory AcceptanceTest of Automatic Capsule Filling Machine Table of Contents System Information Protocol Details Protocol Approval from Customer Objective of this pr... Read more
The development of product prior to the preparation of the first pilot-production batch. The development activities are listed as follows: 1. Formulation design, selection, and optimization... Read more