Practical GMP, QA and QC guidance for pharma professionals

Browse by topic

• Quality AssuranceGMP systems, deviations, CAPA, change control, batch release44
• Quality ControlTesting, HPLC, OOS investigations, reagents, lab practice44
• MicrobiologyWater testing, sterility, media fill, environmental monitoring14
• ValidationProcess, cleaning, HVAC and equipment qualification13
• SOPExample SOP templates to adapt to your own quality system48
• Regulatory AffairsDossiers, inspections, warning letters, interview prep11
• Stability StudyICH stability conditions, chambers, OOT trends4
• ProductionManufacturing areas, equipment operation and cleaning5

• 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)

• Stability Study · 18 Oct 2026

  Bracketing and Matrixing Designs for Stability Study (ICH Q1D)

  Learn how ICH Q1D bracketing and matrixing reduce stability testing: when each design applies, design factors, examples, risks and the status of the new ICH Q1 revision.

• Microbiology Study · 18 Oct 2026

  Electron Transport Chain (ETC): Steps, Complexes and ATP Yield

  Electron transport chain for students: complexes I to IV, ubiquinone, cytochrome c, proton gradient, ATP synthase and ATP yield per NADH and FADH2.

• Packaging · 18 Oct 2026

  Guidelines on Packaging for Pharmaceutical Products (WHO TRS 902)

  Plain-language summary of the WHO guidelines on packaging for pharmaceutical products: functions, materials, closures, labels, QA and packaging-line controls.

• Quality Assurance · 18 Oct 2026

  Microbial Contamination of Compressed Air in Pharma

  How microbial contamination of compressed air happens in pharma plants, and how to control and monitor it using EU GMP Annex 1 rules for product-contact gases.

• Quality Assurance · 18 Oct 2026

  Performance Qualification (PQ) Protocol and Report Format

  Performance qualification (PQ) protocol and report format for pharma equipment: Annex 15 expectations, an example procedure, deviation handling and sign-off.

• Validation · 18 Oct 2026

  Qualification Stages: URS, DQ, FAT/SAT, IQ, OQ and PQ

  Understand the qualification stages for equipment, facilities, utilities and systems: URS, DQ, FAT/SAT, IQ, OQ, PQ and re-qualification under EU GMP Annex 15.

• Quality Control · 18 Oct 2026

  Reference Substances and Reference Materials in the QC Lab

  How a QC laboratory should register, label, store, retest and trace primary and secondary reference substances and reference materials, per WHO and ICH Q7.

• Quality Control · 18 Oct 2026

  SOP for Cleaning of a Quality Control Laboratory

  Example SOP for daily cleaning of a pharmaceutical quality control laboratory: floor, walls, doors, windows, benches, racks and instruments, with frequencies and records.

• Packaging · 18 Oct 2026

  SOP for Closing the Packaging Line During Tea and Lunch Breaks

  Example SOP for closing a packaging line during tea and lunch breaks: machine switch-off checks, pack segregation, mix-up prevention and the GMP basis.