Practical GMP, QA and QC guidance for pharma professionals

Browse by topic

• Quality AssuranceGMP systems, deviations, CAPA, change control, batch release38
• Quality ControlTesting, HPLC, OOS investigations, reagents, lab practice36
• MicrobiologyWater testing, sterility, media fill, environmental monitoring10
• ValidationProcess, cleaning, HVAC and equipment qualification10
• SOPExample SOP templates to adapt to your own quality system36
• Regulatory AffairsDossiers, inspections, warning letters, interview prep10
• Stability StudyICH stability conditions, chambers, OOT trends3
• ProductionManufacturing areas, equipment operation and cleaning4

• ICH Q2(R2) and Q14: new analytical validation and development guidelinesICH · 16 Oct 2026
• Revised Schedule M (G.S.R. 922(E)): what changed in India's GMP rules and the deadlinesOther · 16 Oct 2026
• FDA QMSR now in effect: 21 CFR Part 820 aligned with ISO 13485FDA · 16 Oct 2026

• Mean Kinetic Temperature (MKT) CalculatorMean kinetic temperature from your temperature log
• F₀ Sterilization Lethality CalculatorSterilisation lethality from time–temperature data
• Dilution, Molarity and Normality CalculatorC₁V₁ = C₂V₂, molarity, normality, unit conversion
• HPLC System Suitability CalculatorResolution, plate count, tailing factor, %RSD
• Pharmaceutical Sampling Plan CalculatorWHO n, p and r plans for incoming containers

Start here

• New to pharma

  Students and freshers

  1. Good manufacturing practices for pharmaceutical products
  2. What Is Data Integrity in the Pharmaceutical Industry?
  3. Quality Risk Management in Pharma (ICH Q9 R1) Explained
  4. Stability Testing: Why It Matters, Climatic Zones and Conditions

• QC analyst

  Lab and instrument work

  1. SOP for Good Chromatography Practices in QC Laboratory
  2. HPLC Calibration Guide Part 1: Parameters and Procedures
  3. OOS Investigation (US FDA): Phase I Laboratory Investigation
  4. Example SOP for QC Reagents and Volumetric Solutions

• QA officer

  Quality systems day to day

  1. SOP on Change Control in Pharmaceutical Manufacturing
  2. SOP on Handling of Incidents and Deviations (Example)
  3. CAPA Process: 15 Step-by-Step Instructions for Pharma QA
  4. SOP for BMR and BPR review

• Inspection ready

  Audits and regulator visits

  1. Data Integrity Problems in an FDA Warning Letter: Lessons
  2. Validation Master Plan (VMP): Contents and Example Outline
  3. Annual Product Quality Review (APQR) as per EU GMP: Example SOP
  4. SOP for Vendor Management in Pharma (Example Template)

• Microbiology · 16 Oct 2026

  Antimicrobial Effectiveness Testing: Purpose and Legacy Method Notes

  Learn what antimicrobial effectiveness testing assesses, how USP <51> relates to preservative use, and why legacy method values need current chapter verification.

• Microbiology · 16 Oct 2026

  Microbiological Data Review Checklist

  Microbiological data review checklist for QC records, raw data, controls and calculations; align common-test reviews with approved methods and site procedures.

• Quality Assurance · 16 Oct 2026

  Pharmaceutical GMP Terms: A Contextual Glossary

  A plain-language glossary of pharmaceutical GMP terms, based on WHO terminology and GMP guidance, with notes on context, batch records and local regulatory use.

• Quality Control · 16 Oct 2026

  QC Laboratory Safety Rules

  General QC laboratory safety rules for risk-based procedures, chemical handling, PPE, emergencies and waste management, with current WHO guidance and local adaptation.

• Microbiology · 16 Oct 2026

  Glycolysis: Pathway and Net Yield

  Glycolysis explained as a ten-step pathway, with key intermediates, enzymes, ATP investment and net yield, plus links to related metabolism topics.

• Quality Control · 16 Oct 2026

  GMP Requirements for a Certificate of Analysis (CoA)

  Learn what a pharmaceutical CoA and analytical report contain, how WHO and EU GMP guidance differ, and why requirements depend on product and market.

• Quality Assurance · 16 Oct 2026

  GMP Documentation: Specifications and Retention

  This guide explains GMP controls for specifications, document changes and batch-record retention, and separates current EU, Indian and US requirements.

• Quality Assurance · 16 Oct 2026

  EU GMP Documentation: Batch Processing and Packaging Records

  Good documentation practices for EU GMP batch and packaging records: key instructions, traceability, approvals, sampling, testing and retention requirements.

• Quality Control · 16 Oct 2026

  HVAC System Qualification Protocol (Validation)

  A risk-based outline for qualifying and requalifying pharmaceutical HVAC and cleanroom systems, with site-specific criteria clearly separated from guidance.