Quality Assurance, GMP, ICH and Quality System Notes [U-1]

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Quality Assurance and Quality Management concepts

  • Quality Control (QC)
  • Quality Assurance (QA)
  • Good Manufacturing Practices (GMP)

Total Quality Management (TQM)

  • Total Quality Management (TQM)
  • Philosophies of TQM

ICH Guidelines

  • ICH Guidelines
  • Purpose of ICH Guidelines
  • ICH Participants
  • Process of Harmonization
  • Brief Overview of QSEM
  • ICH Stability Testing Guidelines (Q1)

Quality by design (QbD)

  • Definition of QbD
  • Elements & Tools Used in QbD

ISO 9000 & ISO14000

  • ISO 9000 Series
  • ISO 14000 Series

NABL accreditation

  • NABL Accreditation
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Other Units of Pharmaceutical Quality Assurance

Unit 2
Unit 3
Unit 4
Unit 5
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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Unit I – Biotechnology in Pharmaceutical Sciences

1. Introduction to Biotechnology

  • Definition and scope.
  • Role in drug development, diagnostics, and therapeutics.

2. Enzyme Biotechnology

  • Immobilization Methods: Adsorption, covalent bonding, entrapment, encapsulation, cross-linking.
  • Applications: Drug synthesis, diagnostics, waste treatment.

3. Biosensors

  • Working Principle: Biorecognition element + transducer → measurable signal.
  • Pharmaceutical Applications: Drug quality control, pathogen detection, fermentation monitoring.
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4. Protein Engineering

  • Overview of techniques (site-directed mutagenesis, directed evolution).
  • Designing proteins with improved stability, activity, or specificity.

5. Industrial Use of Microbes

  • Role in large-scale bioprocesses.
  • Enzyme Production – General considerations: strain selection, growth conditions, downstream processing.
  • Examples:
    • Amylase – starch breakdown.
    • Catalase – hydrogen peroxide decomposition.
    • Peroxidase – oxidation reactions.
    • Lipase – fat hydrolysis.
    • Protease – protein breakdown.
    • Penicillinase – β-lactam antibiotic hydrolysis.

6. Genetic Engineering – Basic Principles

  • Gene isolation, cloning, and expression.
  • Tools: Restriction enzymes, vectors, host cells.
  • Applications: recombinant drugs, vaccines, therapeutic proteins.

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

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