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
Pharmaceutical Quality Assurance
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Other Subjects of B Pharmacy 6th Semester
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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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
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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