Complaints & Document Management Notes [U-4]
Buy Premium
Get The High-Quality Pdf Notes on App
Advertisements
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
Advertisements
Other Units of Pharmaceutical Quality Assurance
Pharmaceutical Quality Assurance
Advertisements
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
Advertisements
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
Advertisements
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.
Advertisements
Thank you for reading from Firsthope's notes, don't forget to check YouTube videos!
