Contact Me

Contact Us

Thank you for visiting Pharmaceutical Microbiology. We value communication with our readers and welcome questions, feedback, and suggestions related to the educational content published on this website.

This Contact page is intended to support communication regarding general inquiries, educational clarifications, content feedback, and collaboration opportunities related to pharmaceutical microbiology learning and awareness.

How You Can Contact Us

You may reach us through the following method:

Email: siva17092@gmail.com

We aim to review messages related to educational topics, website content, or technical questions as time permits.

Important Communication Notice

Please note that Pharmaceutical Microbiology does not provide medical, clinical, regulatory consulting, or professional advisory services.

Emails requesting personalized medical advice, regulatory approvals, audit consulting, or operational decision-making support will not be responded to.

Readers are encouraged to consult qualified professionals, regulatory authorities, or their organization’s internal quality systems for official guidance.

Educational Purpose Reminder

All communication through this page is subject to the educational scope of this website. Any information shared or discussed remains general in nature and is intended only to support learning and professional awareness.

By contacting us, you acknowledge and agree to the terms outlined in our Medical Disclaimer, Privacy Policy, and Terms & Conditions.

We appreciate your interest in Pharmaceutical Microbiology and thank you for being part of a learning-focused community dedicated to quality, compliance, and patient safety.

Comments

Post a Comment

💬 Share your thoughts or questions about this topic below.
I personally reply to every comment — your ideas make this blog better!

Popular posts from this blog

Too Numerous To Count (TNTC) and Too Few To Count (TFTC) in Microbiology: Meaning, Limits, Calculations, and GMP Impact

Image
Too Numerous To Count (TNTC) and Too Few To Count (TFTC) in Microbiology – Meaning, Limits, Calculations & GMP Impact Too Numerous To Count (TNTC) and Too Few To Count (TFTC) in Microbiology In pharmaceutical microbiology, accurate enumeration of microorganisms is a critical quality attribute. Terms like Too Numerous To Count (TNTC) and Too Few To Count (TFTC) are routinely used during microbial enumeration, environmental monitoring, water testing, and finished product analysis. Misinterpretation of TNTC and TFTC is one of the top causes of audit observations during FDA, WHO, and regulatory inspections. This article provides a deep, regulatory-grade explanation of: Exact meaning of TNTC and TFTC Accepted numerical limits Calculation rules with examples USP, PDA, GMP expectations Deviation and investigation handling Audit-ready documentation practices 1. What is Colony Forming Unit (CFU)? Before understanding TNTC and TFTC, it is essentia...
Read more

Non-Viable Particle Count (NVPC) in Cleanrooms: Principles, Methods & GMP Requirements

Image
Non-Viable Particle Count (NVPC) in Cleanrooms: Principles, Monitoring Methods & GMP Compliance Guide Non-Viable Particle Count (NVPC) in Cleanrooms: Principles, Methods & GMP Requirements 1. Introduction to Non-Viable Particle Count (NVPC) Non-Viable Particle Count (NVPC) refers to the measurement of inert, non-living airborne particles present in a controlled cleanroom environment. Unlike viable particles (microorganisms), NVPC does not indicate biological contamination but serves as a critical indirect indicator of cleanroom cleanliness, HVAC performance, and contamination control effectiveness. In pharmaceutical manufacturing, sterile processing, medical devices, and biologics, NVPC monitoring is a mandatory GMP requirement under global regulatory frameworks such as ISO 14644 , EU GMP Annex 1 , USP , and PDA . 2. What Are Non-Viable Particles? Non-viable particles are solid or liquid airborne particles that: Do not contain living organisms A...
Read more

Alert and Action Limits in Environmental Monitoring: GMP Meaning, Differences & Best Practices

Image
Alert and Action Limits in Environmental Monitoring: GMP Meaning, Differences & Best Practices Alert and Action Limits in Environmental Monitoring: GMP Meaning, Differences & Best Practices 1. Introduction to Environmental Monitoring (EM) in GMP Environmental Monitoring (EM) is a critical component of Good Manufacturing Practices (GMP) that ensures pharmaceutical manufacturing environments remain under microbial and particulate control. In sterile and non-sterile manufacturing, EM data is not only collected but scientifically interpreted using alert limits and action limits to detect early signs of loss of environmental control. 2. What Are Alert and Action Limits? 2.1 Alert Limit – GMP Definition An alert limit is a statistically derived microbiological or particulate level that signals a potential deviation from normal operating conditions. Usually set at ±2 sigma (2σ) Indicates early warning Does NOT require batch rejection Triggers increas...
Read more