Pharmatext

Build Greater Confidence in E&L Screening-USP Technical Guide

How confident are you in your E&L screening?

Non-targeted screening must detect a broad and largely unknown range of organic extractables and leachable. Differences in instruments, methods, and laboratory workflows can make demonstrating consistent performance difficult.

This USP Technical Guide explores how standardized system suitability mixtures can help laboratories verify critical performance attributes, including chromatographic range, sensitivity, specificity, precision, and system stability.

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Kent's Comparative Repertory of The Homoeopathic Materia Medica

Kent’s Comparative Repertory of Homoeopathic Materia Medica is an important work by Dr. Dockx & Dr. Kokelenberg. This work aims to help the users of Kent’s Homoeopathic Repertory in grasping the very essence of the book- understanding the meaning of each rubric, completing each rubric and gathering all the additional rubrics and remedies and cross references by a variety of reliable authors- the tasks essential to convert patients’ symptoms in the language of Kent’s Repertory. Therefore, this book is a helping hand for the physicians and students alike to overcome the problem of understanding the exact meaning of each rubric and to differentiate amongst the closely related ones such as 'Abandonned and Forsaken'

KEY FEATURES:

Explanation of meanings of each rubric along with their cross references

Explanation of the important remedies including the, additions from other renowned repertories and materia medica

Additional information such as differential diagnosis for the remedies, clinical tips for various conditions and the dosage of various remedies, sources of additional remedies etc.

Thorough explanation of the Mind chapter of Kent’s Repertory which is very important for Homeopathic treatment of diseases.

A bonus to all readers of this book- The comparison of the rubrics in Kent's repertory with the similar ones under other repertories such as Boericke pocket book, BBCR, Barthel's repertory etc which have been extensively presented in this book- A benefit to both students and practitioners of homeopathy.

36 references from various important repertories and materia medica: Kent’s Repertory of Homoeopathic Materia Medica with word and thumb index, Kent’s Lectures in Materia Medica with New Remedies, Knerr’s Repertory of Hering’s Guiding Symptoms, Boger’s Boenninghausens’s Characteristics and Materia Medica, Jahr’s Repertory.

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Pharma Times IPA: September 2026

We’re delighted to present the September 2026 Edition of Pharma Times.

Centered on the theme Rational Use of Medicines, this edition brings together insights from distinguished global experts across India, Australia, Malaysia, Kazakhstan, and Moldova to address the critical need for purposeful prescribing, robust clinical governance, and holistic patient care.

Here's what awaits you in this issue:

1. Rational Use of Medicines: “Prescribe with Purpose, Use with Care, Smart Choices for a Healthy Future”: A foundational overview emphasizing the clinical imperatives of judicious drug prescribing and responsible medication use.

2. Improving Clinical Protocols and the List of Essential Medicines for Children: International Experience and Current Approaches: An examination of global strategies and evidence-based frameworks designed to optimize pediatric clinical practice guidelines.

3. Prescribe with Purpose, Use with Care: Why We Teach Drugs But Never Teach Care: An eye-opening article, especially for the next generation of prescribers, that strongly advocates for rational use of medicines.

4. Nutraceuticals and Their Potential Health Benefits: Appropriate Use, Common Irrationalities and Patient-Safety Safeguards: An evaluation of the evidence behind dietary supplements, addressing improper usage trends, safety concerns, and the need for evidence-backed guidance.

5. Responsibly Using Medicines in All Sectors for Sustainability!: An exploration of multi-sectoral approaches to sustainable pharmaceutical consumption, highlighting environmental stewardship and antimicrobial management.

6. Sustaining India’s Pharmaceutical Leadership: From the Pharmacy of the World to Patient-Centered Pharmaceutical Care : A strategic analysis on transitioning from volume-driven drug manufacturing to value-added, patient-focused healthcare delivery.

7. Transforming Pharmacy Education: From Traditional Learning to NEP-Aligned, Future-Ready Education: A forward-looking review of curricular reform, aligning pharmaceutical pedagogy with modern clinical demands and national educational policies.

8. Enduring Legacy of Acharya P. C. Ray: An Architect of Indian Chemical & Pharmaceutical Renaissance: A historical retrospective honoring the profound vision, industrial spirit, and scientific contributions of the 'Father of Indian Chemistry'.

9. Five Realities That Deserve Immediate Attention Before Prioritizing the Implementation of NEP 2020 at the Grassroots Level: A pragmatic critique identifying key operational and structural challenges in executing educational reforms within frontline institutions.

We are sure you would find this compilation interesting and informative!

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IPEC Qualification of Excipients for Use in Pharmaceuticals – Guide & Checklist | Version 3, 2026

Pharmaceutical excipients play a critical role in the quality, performance, stability, safety, and manufacturability of medicinal products. Proper qualification of excipients and their suppliers is therefore an important element of pharmaceutical quality management.

The IPEC Federation’s “Qualification of Excipients for Use in Pharmaceuticals: Guide & Checklist – Version 3, 2026” provides an updated framework for excipient suppliers and pharmaceutical manufacturers to understand key expectations associated with the qualification and use of pharmaceutical excipients.

This comprehensive guide covers the excipient qualification process, including:

Purpose, scope and principles of excipient qualification
General guidance on excipient manufacture, regulation and controls
Excipient functionality and intended use
Regulatory and safety assessment
Novel excipients and precedence of use
Pharmacopeial requirements
Excipient DMFs, CEPs and regulatory dossiers
Manufacturing, packaging and process validation
Test methods, specifications and stability
Excipient development and specification processes
Performance indicators and consistency control
Product information and confidential information
Excipient selection criteria
Compatibility and performance considerations
Supply and regulatory considerations
Excipient manufacturer qualification
Annex A – Qualification Checklist for practical evaluation of excipients and excipient suppliers.

The guide emphasizes the relationship between excipient suppliers and pharmaceutical excipient users, with the objective of establishing appropriate quality, technical, regulatory and communication controls. It also provides practical considerations for assessing excipients according to their intended application, route of administration, quality attributes and performance requirements.

For pharmaceutical manufacturers, QA, QC, Regulatory Affairs, R&D, Procurement, Technical Services and Supplier Quality teams, this guide can serve as a useful reference when developing or reviewing an excipient qualification programme.

Important Note

The IPEC document states that it is voluntary guidance and not a regulatory requirement, and that applicable national/regional regulatory requirements should be reviewed separately.

Reference: International Pharmaceutical Excipients Council (IPEC) Federation – Version 3, 2026.

Explore more pharmaceutical quality, GMP and regulatory resources:

PharmaText® – www.pharmatext.co.in

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Pharmaceutical Batch Records: A Practical GMP Guide to MBR, BMR, BPaR & Electronic Batch Records

Free Download – PDF eBook by Pharmatext

In pharmaceutical manufacturing, a batch is not considered fully controlled simply because the product has been manufactured correctly. The documentation must tell the complete story of what happened.

From the Master Batch Record (MBR) and Batch Manufacturing Record (BMR) to Batch Packaging Records (BPaR), QC documentation, equipment records and Electronic Batch Records (EBRs) — every record plays an important role in GMP compliance, traceability and batch release.

📖 What will you learn in this eBook?

This practical eBook provides a structured overview of:

✅ What are Batch Records?
✅ Different types of pharmaceutical batch records
✅ Master Batch Record (MBR)
✅ Batch Manufacturing Record (BMR)
✅ Batch Packaging Record (BPaR)
✅ Cleaning & Equipment Use Records
✅ Analytical & Quality Control Records
✅ Electronic Batch Records (EBR)
✅ How to create and manage batch records
✅ Real-time documentation & data integrity
✅ Deviation, hold and atypical-event documentation
✅ Batch record review, reconciliation and release
✅ Batch Record Lifecycle
✅ Archival and retention
✅ EBR, audit trails and electronic signatures
✅ Integration with MES, LIMS and quality systems
✅ Regulatory requirements under EU GMP, FDA 21 CFR Part 211 and ICH Q7

🔍 Why should you download it?

A well-maintained batch record provides the factual history required to understand what was done, when it was done, who performed it, what materials and equipment were used, and whether the results remained within approved limits.

The ebook also explains how the industry is moving from traditional paper documentation toward Electronic Batch Records, including audit trails, electronic signatures, automated data capture, review-by-exception and improved traceability.

🎯 Who should download this eBook?

This resource can be useful for:

QA • QC • Production • IPQA • Regulatory Affairs • GMP Professionals • Validation & CSV Teams • Pharmaceutical Manufacturing Professionals • Pharma Students • Auditors & Consultants

Whether you work with paper BMRs today or are preparing for a transition toward EBR/MES-based manufacturing, this eBook provides a useful reference for understanding the complete batch-record lifecycle.

📥 Download Your FREE Copy

Don't just manufacture a batch — understand the documentation that proves how it was manufactured.

📚 Learn GMP. Strengthen Documentation. Improve Data Integrity.

About Pharmatext

Pharmatext shares practical pharmaceutical knowledge, GMP resources, regulatory information, technical guides and educational content for professionals working across the pharmaceutical industry.

🌐 www.pharmatext.co.in

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The GMP/GDP Questions & Answers Guide – Version 3.0 (September 2026)

A Practical Reference Guide for Pharmaceutical GMP & GDP Professionals

GMP and GDP requirements can be complex—and finding clear answers to specific regulatory questions can often be time-consuming.

To make this process easier, The GMP/GDP Questions & Answers Guide – Version 3.0 (September 2026) brings together a comprehensive collection of regulatory questions and answers covering a wide range of pharmaceutical quality and compliance topics.

This 230-page reference guide provides an extensive collection of Q&As covering requirements and regulatory expectations from major international sources, including EMA/EU, FDA (USA), MHRA (UK), ICH and ECA Academy.

🔍 What can you find inside?

The guide covers important areas such as:

EU GMP & GDP requirements
Pharmaceutical Quality Systems
Quality Risk Management (QRM)
Health-Based Exposure Limits (HBEL)
Cross-contamination control
Cleaning and cleaning validation
Production and packaging
Equipment and qualification
Outsourced activities
Complaints, quality defects & recalls
Data Integrity & Data Lifecycle
Computerised Systems
Validation
Active Pharmaceutical Ingredients (APIs)
Sterile manufacturing
Investigational Medicinal Products (IMPs)
Safety features and traceability
FDA cGMP requirements
ICH Q7, Q8, Q9 and Q10
Visual inspection
Good Distribution Practices (GDP)
Temperature mapping
Supplier qualification
Deviations and complaints
Bioburden and microbial control
Risk assessment and much more.

👨‍🔬 Who will find this guide useful?

This resource can be particularly useful for:

Whether you are preparing for a GMP inspection, internal audit, regulatory assessment, deviation investigation, CAPA, validation activity, training session or simply looking for clarification on a GMP/GDP requirement, this guide can serve as a useful reference.

📥 Download the Guide

If you work in the pharmaceutical industry and regularly deal with GMP, GDP, Quality Assurance, Regulatory Affairs, Validation or Compliance, this is a resource worth keeping in your professional reference library.

Download the complete GMP/GDP Questions & Answers Guide – Version 3.0 (September 2026) and keep this valuable regulatory reference at your fingertips.

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Method Validation in Pharmaceutical Analysis

Method Validation is a critical process in pharmaceutical analytical laboratories to demonstrate that an analytical method is fit for its intended purpose, reliable, accurate, and reproducible.

This Pharmatext presentation covers the key parameters of analytical method validation:

🔹 Accuracy
🔹 Precision
🔹 Limit of Detection (LOD)
🔹 Limit of Quantitation (LOQ)
🔹 Specificity / Selectivity
🔹 Linearity & Range
🔹 Robustness & Ruggedness
🔹 System Suitability

A useful learning resource for Pharmaceutical QC & QA Professionals, Analytical Scientists, Laboratory Personnel, Pharma Students, and Industry Professionals.

📌 Learn. Validate. Ensure Reliable Analytical Results.

🌐 www.pharmatext.co.in

Free Download 46 Pages PDF

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