GMP: Personnel, Premises & Equipment Control Notes [U-2]
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Organization and personnel
- Personnel responsibilities
- Training
- Personnel Hygiene
- Personnel Records
Premises
- Premises
- Design and Construction of Pharmaceutical Premises
- Plant Layout in Pharmaceutical Manufacturing
- Maintenance and Sanitation in Pharmaceutical Facilities
- Environmental Control in Pharmaceutical Facilities
- Utilities
- Maintenance of Sterile Areas
- Control of Contamination
Equipment and raw materials
- Equipment Selection
- Purchase Specifications for Equipment
- Maintenance of Equipment
- Purchase Specifications for Raw Materials
- Maintenance of Stores for Raw Materials
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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
Unit II Summary – GMP Personnel & Premises Equipment Notes
1. Organization & Personnel
- Responsibilities: Clear role definitions for all staff levels.
- Training: Continuous GMP/GDP training, skill development.
- Hygiene: Personal cleanliness, protective clothing, health monitoring.
- Personal Records: Documentation of qualifications, training history, medical fitness.
2. Premises
- Design & Layout: Logical workflow to avoid cross-contamination; easy cleaning.
- Construction: Durable, non-reactive, smooth surfaces.
- Maintenance & Sanitation: Regular upkeep, pest control, validated cleaning procedures.
- Environmental Control: Temperature, humidity, dust, and microbial control.
- Utilities: Water, air handling, lighting, drainage systems.
- Sterile Areas: Air filtration (HEPA), pressure differentials, controlled entry.
- Contamination Control: Zoning, gowning, restricted access.
3. Equipment & Raw Materials
- Equipment Selection: Based on process needs, GMP compliance.
- Purchase Specifications: Performance, material compatibility, safety standards.
- Maintenance: Preventive maintenance schedules, calibration.
- Raw Material Stores: Controlled environment, segregation, labeling.
- Material Specifications: Quality parameters, supplier qualification
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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