Practical GMP, QA and QC guidance for pharma professionals

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• Quality AssuranceGMP systems, deviations, CAPA, change control, batch release81
• Quality ControlTesting, HPLC, OOS investigations, reagents, lab practice85
• MicrobiologyWater testing, sterility, media fill, environmental monitoring27
• ValidationProcess, cleaning, HVAC and equipment qualification25
• SOPExample SOP templates to adapt to your own quality system114
• Regulatory AffairsDossiers, inspections, warning letters, interview prep15
• Stability StudyICH stability conditions, chambers, OOT trends4
• ProductionManufacturing areas, equipment operation and cleaning22

• 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)

• Quality Assurance · 28 Oct 2026

  GMP for Capsule Manufacturing: Controls That Protect Quality

  Practical guide to GMP for capsule manufacturing in India: quality system, premises, shell and moisture control, filling checks, testing, records and audits.

• Microbiology · 28 Oct 2026

  Methods of Sterilisation: General Introduction (Ph. Eur. 5.1.1)

  Ph. Eur. 5.1.1 sterilisation introduction: sterility assurance, terminal sterilisation, aseptic processing and parametric release, checked against EU GMP Annex 1.

• Packaging · 28 Oct 2026

  SOP for Cleaning of Capping Machine (Example Template)

  Example SOP for cleaning a bottle capping machine between products and batches, with safety steps, parts checklist, status labels, hold times and records.

• Packaging · 28 Oct 2026

  SOP for Cleaning of Cotton Inserter Machine (Example Template)

  Example SOP for cleaning a cotton inserter machine on a bottle packing line between products and batches, with labels, hold times and records.

• Packaging · 28 Oct 2026

  SOP for Cleaning of De-blistering Machine (Example)

  Example SOP for cleaning a de-blistering machine: product-to-product and batch-to-batch cleaning, labels, hold times and records, to prevent cross-contamination.

• Packaging · 28 Oct 2026

  SOP for Cleaning of Lifter and Swiveller (Example Template)

  Example SOP for cleaning a lifter and swiveller on a packing line between batches and products, with status labels, hold times and records.

• Packaging · 28 Oct 2026

  SOP for Cleaning of Leaflet Folding Machine (Example Template)

  Example SOP for cleaning an off-line leaflet folding machine between products and batches, with safety steps, parts checklist, status labels and records.

• Packaging · 28 Oct 2026

  SOP for Cleaning of Strip Pack Machine

  Example SOP for cleaning a strip pack machine between products and between batches: safety, dismantling, washing, drying, labelling and clean-hold time.

• Packaging · 28 Oct 2026

  SOP for Entry and Exit to Packaging Department

  Example SOP for entry to and exit from a pharmaceutical packaging department: change room steps, garments, hand disinfection, toilet breaks and exit, with FAQs.