Complaints & Document Management Notes [U-4]
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Complaints
- Complaints
- Evaluation of complaints
- Handling of return good
- Product Recall
- Waste Disposal
Document maintenance in pharmaceutical industry
- Batch Formula Record (BFR) / Batch Manufacturing Record (BMR)
- Master Formula Record (MFR)
- Standard Operating Procedures (SOPs)
- Quality Audit
- Quality Review
- Quality Documentation
- Reports and Documents
- Distribution records
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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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Summary of Complaints & Document Management Notes
1. Complaints Management
- Complaint Evaluation: Each customer or regulatory complaint is assessed to find the cause, verify the claim, and decide on corrective actions.
- Handling Returned Goods: Returned products are checked for quality, reason for return, and whether they can be reused, reprocessed, or destroyed.
- Product Recall: If safety, quality, or compliance issues are found, products are traced through distribution records and removed from the market quickly and effectively.
- Waste Disposal: Unusable or defective products and materials are disposed of in compliance with environmental and safety rules.
2. Document Maintenance in the Pharmaceutical Industry
- Batch Formula Record (BFR): Step-by-step manufacturing details for a specific batch, ensuring repeatability and traceability.
- Master Formula Record (MFR): The standard reference for product manufacturing, covering materials, quantities, and processes.
- Standard Operating Procedures (SOPs): Written instructions for consistent operations.
- Quality Audit & Quality Review: Regular checks to confirm compliance, identify improvements, and maintain product standards.
- Quality Documentation: Centralized storage of all quality-related data for verification and inspections.
- Reports & Records: Accurate logs of production, testing, and distribution.
- Distribution Records: Detailed tracking of product movement for recalls, complaint resolution, and regulatory compliance
At FirstHope, we provide BPharm notes that are topic-wise, easy to understand, and designed strictly as per AKTU and Other Universities, designed according to PCI syllabus.
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