1. Purpose of Handling and Testing of In-process Samples
The purpose of this Standard Operating Procedure (SOP) for Handling and Testing of In-process Samples is to define the guidelines for the proper handling and testing of in-process samples within [Company Name]. This procedure ensures the accuracy, integrity, and compliance of in-process testing in the manufacturing process.
2. Scope of Handling and Testing of In-process Samples
This SOP for Handling and Testing of In-process Samples applies to all personnel involved in the collection, handling, and testing of in-process samples within [Company Name]. It encompasses the procedures for sample collection, labeling, transportation, testing, and documentation.
3. Definitions involved in Handling and Testing of In-process Samples
3.1 In-process Samples:
Samples taken at various stages of the manufacturing process to monitor and control the quality and consistency of the product.
4. Safety Precautions and Personal Protective Equipment (PPE)
4.1. PPE Requirements
4.1.1 Personnel involved in sample collection and testing must wear appropriate PPE, including lab coats, safety goggles, gloves, and any additional PPE as required.
4.1.2 Ensure that PPE is in good condition and properly fitted.
4.2. Chemical Safety
4.2.1 Handle all chemicals and solvents involved in sample testing with care, following manufacturer instructions and safety data sheets.
4.2.2 Store chemicals in designated areas away from incompatible substances.
5. Equipment and Materials
5.1. Sampling Tools
5.1.1 Ensure the availability and proper functioning of sampling tools, such as pipettes, syringes, and containers, required for sample collection.
5.1.2 Maintain sampling tools in a clean and calibrated state.
5.2. Laboratory Equipment
5.2.1 Ensure that all laboratory equipment used for sample testing, such as analytical balances, spectrophotometers, or chromatography systems, is in proper working condition and calibrated.
6. In-process Sample Handling and Testing Procedure
6.1. Sample Collection
6.1.1 Collect in-process samples at predetermined intervals as per the approved sampling plan.
6.11.2 Use appropriate sampling tools and techniques to ensure representative samples are obtained.
6.2. Sample Labeling
6.2.1 Label each sample container with essential information, including sample ID, date, time, location, and any other relevant details.
6.2.2 Ensure that labels are securely attached and legible.
6.3. Sample Transportation
6.3.1 Transport samples to the testing area promptly and under controlled conditions to prevent contamination or degradation.
6.4. Sample Testing
6.4.1 Perform the required tests on in-process samples according to approved test methods and specifications.
6.4.2 Record all test results accurately and in compliance with data integrity principles.
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Pharmacareer team is a team of Experts from every department of Pharmaceutical industry having enriched experience. Experts have work experience of many multinational pharmaceutical industries worldwide.