Calibration and Warehousing Notes [U-5]

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Calibration and Validation

  • Calibration
  • Qualification in Pharmaceutical Quality Assurance
  • Validation in Pharmaceutical Quality Assurance
  • Types of Validation
  • Validation Master Plan (VMP)
  • Calibration of pH Meter
  • Qualification of UV-Visible spectrophotometer
  • General Principles of Analytical Method Validation

Warehousing

  • Warehousing
  • Good Warehousing Practice (GWP)
  • Materials management
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Other Units of Pharmaceutical Quality Assurance

Unit 1
Unit 2
Unit 3
Unit 4
Pharmaceutical Quality Assurance
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Other Subjects of B Pharmacy 6th Semester

Herbal Drug Technology

Topic wise notes of:

Herbal Drug Technology

  • Herbal Raw Materials & Indian Medicine Systems
  • Nutraceuticals: Uses, Herbs & Interactions
  • Herbal Cosmetics, Excipients & Formulations
  • Herbal Drug Evaluation, Patents & Regulations
  • Herbal Industry: Scope, GMP & Infrastructure
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Absorption & Distribution

Topic wise notes of:

Biopharmaceutics and Pharmacokinetics

  • Biopharmaceutics: Absorption & Distribution
  • Drug Elimination, Bioavailability & Bioequivalence
  • Pharmacokinetics Models, Dosing & Parameters
  • Multicompartment models
  • Nonlinear Pharmacokinetics
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Pharmacology III Respiratory and GI Tract

Topic wise notes of:

Pharmacology III

  • Respiratory & GI Tract Drug Pharmacology
  • Chemotherapy: Principles & Key Antibiotics
  • Chemotherapy: TB, Fungal & Parasitic Drugs
  • UTIs, Cancer Chemo & Immunopharmacology
  • Toxicology Basics & Chrono pharmacology
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Antibiotics & Aminoglycosides in Medicinal Chemistry III

Topic wise notes of:

Medicinal Chemistry III

  • Antibiotics & Aminoglycosides
  • Antibiotics & Antimalarials: Structures & SAR
  • Anti-TB, UTI & Antiviral Agents
  • Antifungals, Antiprotozoals & Sulfonamides
  • Intro to Drug Design & QSAR Approaches
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Pharmaceutical Biotechnology

Topic wise notes of:

Pharmaceutical Biotechnology

  • Introduction to Pharmaceutical Biotechnology
  • Genetic Engineering & rDNA Technology
  • Immunology and Vaccine Technology
  • Microbial Genetics & Biotransformation
  • Fermentation & Bioproduct Production
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Summary of Calibration and Warehousing Notes

1. Calibration and Validation

  • Introduction & Definitions: Calibration ensures instruments give accurate results. Validation confirms that processes, methods, and equipment consistently deliver the intended outcome. Qualification is the documented verification that equipment is properly installed and works as intended.
  • General Principles: Follow systematic, documented steps for reliability, traceability, and regulatory compliance.
  • Importance & Scope: Essential for maintaining product quality, meeting regulatory standards, and ensuring patient safety.
  • Types of Validation: Includes prospective, concurrent, retrospective, and revalidation.
  • Validation Master Plan (VMP): A high-level document outlining strategy, responsibilities, timelines, and resources for all validation activities.
  • Calibration Example: pH meters must be calibrated using standard buffer solutions.
  • Equipment Qualification Example: UV-Visible spectrophotometers undergo installation, operational, and performance qualification.
  • Analytical Method Validation: Ensures methods are accurate, precise, specific, robust, and reproducible.

2. Warehousing

  • Good Warehousing Practice (GWP): Maintain cleanliness, temperature control, pest prevention, and proper segregation of materials.
  • Materials Management: Efficient receipt, storage, inventory control, and dispatch to ensure quality and traceability of pharmaceutical materials

At FirstHope, we provide BPharm notes that are topic-wise, easy to understand, and designed strictly as per AKTU and Other Universities, designed according to PCI syllabus.

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