Quality Control and Good Laboratory Practice Notes [U-3]

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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

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

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

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 Quality Control and GLP Notes

1. Quality Control

  • Containers: Ensure integrity, strength, and compliance with specifications.
  • Rubber Closures: Verify elasticity, sealing ability, and chemical compatibility.
  • Secondary Packaging Materials: Inspect for durability, correct labeling, and protection during handling and transport.

2. Good Laboratory Practices (GLP)

  • General Provisions: Establish principles for conducting reliable, reproducible studies.
  • Organization & Personnel: Define roles, qualifications, and training to ensure competence.
  • Facilities & Equipment: Maintain clean, well-equipped spaces suitable for intended testing.
  • Testing Facilities Operation: Implement SOPs for safe and consistent operation.
  • Test & Control Articles: Properly characterize, label, and store samples for accurate results.
  • Protocol for Nonclinical Studies: Develop clear study plans outlining objectives, methods, and analysis.
  • Records & Reports: Keep detailed, accurate, and retrievable documentation.
  • Disqualification of Facilities: Apply regulatory actions if GLP compliance is not maintained.

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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