Practical GMP, QA and QC guidance for pharma professionals

Browse by topic

• Quality AssuranceGMP systems, deviations, CAPA, change control, batch release54
• Quality ControlTesting, HPLC, OOS investigations, reagents, lab practice50
• MicrobiologyWater testing, sterility, media fill, environmental monitoring18
• ValidationProcess, cleaning, HVAC and equipment qualification16
• SOPExample SOP templates to adapt to your own quality system56
• Regulatory AffairsDossiers, inspections, warning letters, interview prep13
• Stability StudyICH stability conditions, chambers, OOT trends4
• ProductionManufacturing areas, equipment operation and cleaning11

• 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
• Stability Conditions LookupICH and Indian (NDCT Rules) study conditions

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)

• Validation · 19 Oct 2026

  HVAC Qualification and Validation: Key Terms

  A plain-language glossary of HVAC qualification and validation terms for non-sterile pharmaceutical facilities, based on WHO guidance and linked references.

• Quality Control · 19 Oct 2026

  GC Troubleshooting and Qualification in Quality Control

  A practical, source-based approach to GC qualification, system suitability and troubleshooting without treating model-specific values as universal limits.

• Validation · 19 Oct 2026

  Installation Qualification Protocol for Pharma Equipment

  An illustrative installation qualification protocol for pharma equipment, with an evidence checklist, deviation record and references to EU GMP Annex 15.

• Quality Assurance · 19 Oct 2026

  EU GMP Premises and Equipment: Audit Guide

  An audit guide to EU GMP expectations for pharmaceutical premises and equipment, with Chapter 3 references and notes on risk-based, site-specific controls.

• Production · 19 Oct 2026

  Preparation of a Master Formula Record in Pharmaceutical Manufacturing

  How to prepare a controlled master formula and processing instruction set, with the applicable EU GMP and U.S. drug CGMP requirements distinguished.

• Microbiology · 19 Oct 2026

  Production of sterile pharmaceutical products

  Learn how sterile pharmaceutical products are made using validated terminal sterilisation or aseptic processing, with contamination control and batch review.

• Quality Control · 19 Oct 2026

  SOP for Reviewing Analytical Reports and Data

  Use this illustrative SOP to review pharmaceutical QC reports, calculations, raw data, chromatograms and sign-offs for completeness, traceability and accuracy.

• SOP · 19 Oct 2026

  SOP for Handling Laboratory Reagents

  Illustrative SOP for receiving, labelling, storing, using and disposing of laboratory reagents, with controls for traceability, expiry and chemical safety.

• Production · 19 Oct 2026

  SOP for Handling a Production Tool Kit

  A controlled-procedure template for issuing, transporting, cleaning, inspecting and returning a production or packaging tool kit.