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Books and Guidelines

List of Books and Guidelines

Water and Steam System|Third Edition| Volume 4|ISPE

Sterile Product Manufacturing Facilities|Third Edition| Volume 3|ISPE

Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology| PDA TR 77

Data Integrity Management System for Pharmaceutical Laboratories| PDA TR 80

Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities | PDA TR 70

Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations| PDA TR 69

Application of Single-Use Systems in Pharmaceutical Manufacturing| PDA TR 66

Pharmaceutical Technology Transfer| PDA TR 65

Process Validation: A Lifecycle Approach| PDA TR 60

Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations| PDA TR 54

Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance/PDA TR 48

Quality Risk Management for Aseptic Processes| PDA TR 44

Process Validation of Protein Manufacturing|PDA TR 42

Sterilizing Filtration of Gases| PDA TR 40

Current Practices in the Validation of Aseptic Processing| PDA TR 36

Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products| PDA TR 34

Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals| PDA TR 28

Sterilizing Filtration of Liquids| PDA TR 26

Process Simulation for Aseptically Filled Product| PDA TR 22

Validation of Tangential Flow Filtration in Biopharmaceutical Applications|PDA TR 15

Sterile Pharmaceutical Packaging: Compatability and Stability| PDA TR 5

Validation of Dry Heat Processes used for Depyrogenation and Sterilization|PDA TR 3| Revised

Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control|PDA TR 1

ISPE Baseline Guide Oral Solid Dosage Forms| Volume 2| Third Edition

Pest Control Handbook| ISPE Guide | Second Edition

Cleaning Validation lifecycle – Application, Methods and Controls | ISPE Guide

Quality Laboratory Facilities| ISPE| This Guide describes how to apply a risk assessment to a quality laboratory facility and identify issues to be considered

Sterile Product Manufacturing Facilities| ISPE Volume 3 | Second Edition

Risk-Based Manufacture of Pharmaceutical Products|ISPE Volume 7| First Edition

Water and Steam Systems| ISPE Pharmaceutical Engineering Guide| Volume 4| Second Edition

Water and Steam Systems| ISPE Pharmaceutical Engineering Guide| Volume 4| First Edition

ISPE Good Practice Guide: Cold Chain Management|Facility Requirement|Storage Requirement|Controlled Temperature Storage|Packing/Unpacking Requirement|Transportation

Baseline Guide on Commissioning and Qualifications| ISPE Guide Volume 5|Second Edition

The Theory Behind Automatic Inspection Technologies for Subvisible-To-Visible Particle Detection And Container Closure Integrity| ISPE

Risk Based Approach to compliant GxP Computerized Systems/ISPE GAMP 5 Second Edition

ISPE Containment Manual| ISPE Affiliates

Fundamentals of an Environmental Monitoring Program| PDA TR 13-2022 (Revised)

Ashutosh Kar - Pharmaceutical microbiology

Steam In Place: PDA TR 61

Points to Consider for Biotechnology Cleaning Validation| PDA TR 49

ISPE Baseline Guide for Oral Solid Dosage Forms: Volume 2

ISPE Guide for Commissioning and Qualification: Volume 5

IPQA INTERVIEW PREPARATION Question and Answer Guide

Quality Control Interview Questions for Pharmaceutical industrial job

Interview Q&A for R&D/QC/QA/Production-Freshers Peoples

ANALYTICAL PROCEDURE DEVELOPMENT| ICH Q14

HBEL Limits in cleaning Validation| WHO TRS 1033: Annexure 2

Handbook of Pharmaceutical Excipients

GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS| APIC| 2021

Good manufacturing practices: Water for Pharmaceutical Use: WHO TRS 1033: Annexure 3

Good manufacturing Practices: Guidelines on validation| WHO TRS 1019: Annexure 3

Guidelines on HVAC systems for non-sterile pharmaceutical products| WHO TRS 1010 Annexure 8

Contamination Control Strategy Development in Pharmaceutical Manufacturing| PDA TR 90

Sterile Drug Products Produced by Aseptic Processing| US FDA GMP

Sampling for Pharmaceutical Water, Steam, and Process Gases| ISPE Guide

Project Management for the Pharmaceutical Industry| ISPE Good Practice Guide

INSPECTION OF GOOD DISTRIBUTION PRACTICE (GDP)-PIC/S: PI-041:2023

Pharmaceutical and Medical Device Validation by Experimental Design

Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities-PDA TR 70

ISPE Guide Controlled Temperature Chamber Mapping

Major CQA and CPPs for Solid Dosage manufacturing facility

Determining the number of PPQ Batches using Statistical Tool | ISPE

ISPE Applied Risk Management for Commissioning and Qualification

GAMP 5|A Risk-Based Approach to Compliant GxP Computerized Systems

Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use| PDA TR 51