Practical GMP, QA and QC guidance for pharma professionals

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• Quality AssuranceGMP systems, deviations, CAPA, change control, batch release83
• Quality ControlTesting, HPLC, OOS investigations, reagents, lab practice91
• MicrobiologyWater testing, sterility, media fill, environmental monitoring28
• ValidationProcess, cleaning, HVAC and equipment qualification25
• SOPExample SOP templates to adapt to your own quality system127
• Regulatory AffairsDossiers, inspections, warning letters, interview prep15
• Stability StudyICH stability conditions, chambers, OOT trends4
• ProductionManufacturing areas, equipment operation and cleaning25

• 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 · 29 Oct 2026

  Deviation Management in Pharma: Complete Guide (GMP, CAPA)

  Deviation management in pharma explained: classification, investigation, root cause, CAPA, batch disposition and trending, with a worked example and FAQs.

• Microbiology · 29 Oct 2026

  SOP on Maintenance and Preparation of Anaerobic Culture Suspension

  Example SOP for maintaining Clostridium sporogenes and preparing an anaerobic culture suspension that delivers 10 to 100 CFU per inoculum for microbial limit testing.

• Production · 29 Oct 2026

  Manufacture of Liquids, Creams and Ointments: EU GMP Annex 9

  Practical guide to EU GMP Annex 9 for manufacturing non-sterile liquids, creams and ointments: closed systems, water, equipment design, homogeneity and hold times.

• Quality Control · 29 Oct 2026

  SOP for Certificate of Analysis (CoA) of Finished Product in Word

  Example SOP for preparing a finished product Certificate of Analysis (CoA) from a controlled Microsoft Word template, with data-integrity controls and review.

• Production · 29 Oct 2026

  SOP for Cleaning and Numbering Containers and SS Accessories

  Example SOP for identification numbering and cleaning of stainless steel and HDPE containers, scoops, ladles and tubs used in a manufacturing area.

• Packaging · 29 Oct 2026

  SOP for Cleaning of Carton Weighing Balance

  Example SOP for cleaning a carton weighing balance in packaging: removing previous batch residue, dry wiping, status labels, hold times and records.

• Packaging · 29 Oct 2026

  SOP for Cleaning of Check Weigher (Example Template)

  Example SOP for cleaning an in-line check weigher between products and batches, with safety steps, parts checklist, status labels, hold times and records.

• Packaging · 29 Oct 2026

  SOP for Cleaning of Conveyor Belt (Example Template)

  Example SOP for cleaning a packing-line conveyor belt between products and batches, with safety steps, parts checklist, status labels, hold times and records.

• Packaging · 29 Oct 2026

  SOP for Cleaning of Strapping Machine (Example Template)

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