Questions and Answers
What is the minimum retention period for records related to the finished product after its expiry?
Which of the following is NOT included in the types of records maintained during manufacturing?
What must be done to ensure the integrity of computerized documentation within manufacturing records?
Why is it important to trace back direct manufacturing steps for a finished product?
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What is the purpose of assigning a unique batch number to each manufacturing batch?
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Which type of SOP is specifically designed to aid workers in performing routine operations?
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What is the primary function of manufacturing records in pharmaceutical production?
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Which component of final product specifications details requirements for packaging materials?
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Which type of SOP would cover the procedures related to the maintenance of equipment used in pharmaceutical manufacturing?
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What do specifications for raw materials typically include?
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Study Notes
Records Management
- Specification results must be documented for all raw materials used in production.
- Batch manufacturing, processing, and packaging records need to be detailed and kept.
- Quality Control (QC) analysis results of both bulk and finished products are essential.
- Retain records and samples of finished products for at least one year post-expiry.
- Records should allow for tracing of all direct and indirect manufacturing steps that may affect quality and safety.
Inspections and Compliance
- Regulatory inspectors examine randomly chosen batch records during inspections to assess adherence to Good Manufacturing Practices (GMP).
Manufacturing Record Generation
- Production staff are responsible for printing or photocopying relevant manufacturing formulae and instructions.
- Each batch is assigned a unique batch number for identification.
- Operators must initial and date each completed manufacturing or packing step to ensure accountability.
Additional Documentation
- Supporting documents may include computerized weigh-lot records and charts from equipment like freeze-driers.
- Maintain adequate backup files; access to computerized systems should be restricted to authorized personnel.
Water for Injection (WFI) Distribution
- WFI is stored in stainless steel sealed vessels and circulated through piping to maintain consistent quality.
- Circulation prevents microbial attachment by maintaining a flow rate of approximately 9 ft/s and a temperature around 85°C.
- WFI is cooled before use in biopharmaceutical processing; a separate system may circulate ambient-temperature WFI for immediate use.
- Systems must be sanitized every 24 hours to maintain water quality.
Design Features
- Welding is used to join pipework to avoid bacteria-harboring threaded fittings.
- Dead-legs in piping are eliminated, and smooth bends are used instead of abrupt junctions to facilitate cleaning.
- UV cells are integrated into the system for continuous bactericidal action.
Initial Pipework Cleaning
- Initial cleaning of the pipework involves detergent passage followed by rinsing with water.
- Passivation uses chemical agents to make surfaces less reactive, usually via nitric acid oxidation.
Water Quality Management
- The corrosiveness of WFI at high temperatures can be mitigated by adding ozone, which also allows for prolonged storage at lower temperatures.
- Innovative testing involves considering chemically inert plastics in place of stainless steel for piping.
- Daily quality control checks of WFI and purified water are mandatory, with sanitation required if specifications are not met.
Documentation Practices
- Clear and unambiguous documentation is vital for preventing errors and ensuring traceability of manufacturing processes.
- Standard Operating Procedures (SOPs) provide systematic instructions for routine operations, maintenance, and testing.
Specification Requirements
- Specifications set forth by QC personnel outline exact expectations for raw materials and products, detailing active ingredient percentages and contamination levels.
- Specifications for packaging materials include dimensions, and product labels specify text and dimensions.
- QC ensures that all incoming raw materials meet specifications before use, keeping them in quarantine until approved.
Manufacturing Instructions
- Manufacturing formulae document product details, including name, potency, batch size, and required raw materials and quantities.
- Processing instructions provide step-by-step manufacturing details, equipment used, and precautionary measures.
- Each product has specific labeling and packing instructions detailing text and packing procedure requirements.
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Description
This quiz covers important aspects of records management and compliance in manufacturing, focusing on documentation, inspections, and accountability protocols. It explores the necessity of maintaining detailed records for raw materials, batch processing, and quality control. Learn about Good Manufacturing Practices (GMP) and how they affect product tracking and safety.
