Quality Control and Good Laboratory Practice Notes [U-3]
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Quality Control
- Quality Control Tests for Containers
- Quality Control Parameters for Glass Containers
- Quality Control Parameters for Plastic Containers
- Quality Control Tests for Rubber Closures
- Quality Control Tests for Secondary Packaging Materials
Good Laboratory Practices
- Good Laboratory Practices (GLP)
- Good Laboratory Practices Guidelines (GLP)
Other Units of Pharmaceutical Quality Assurance
Pharmaceutical Quality Assurance
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
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
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.
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