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PIC/SGMP Reference and retention samples 1. SCOPE1. 1.1 This Annex to the Guide to Good Manufacturing Practice for Medicinal Products(the GMP Guide) gives guidance on the taking and holding of reference

How to fill out reference and retention samples

How to fill out reference and retention samples

1. To fill out reference and retention samples, follow these steps:
2. Gather all necessary information and materials.
3. Ensure that the samples and containers are clean and free from any contaminants.
4. Label each sample container with a unique identifier, such as a sample number or barcode.
5. Take appropriate measurements or collect the samples according to the specific requirements.
6. Fill the sample containers with the appropriate sample, ensuring that they are filled to the required level.
7. Seal the sample containers tightly to prevent any leakage or contamination.
8. Keep a record of the sample details, including the date, time, location, and any relevant observations.
9. Store the reference and retention samples in appropriate conditions, such as a controlled temperature or humidity.
10. Follow any additional instructions or guidelines provided by the specific industry or organization that requires the samples.
11. Properly dispose of any waste or unused samples according to the applicable regulations.

Who needs reference and retention samples?

1. Various industries and organizations may require reference and retention samples, including:
2. Research laboratories conducting experiments or studies that require long-term sample preservation for future reference or retesting.
3. Quality control departments in manufacturing industries that need to retain samples for product traceability, quality assurance, and compliance purposes.
4. Environmental monitoring agencies that collect reference samples to compare and validate future samples for accurate analysis.
5. Food and beverage companies that retain samples in case of consumer complaints, quality control investigations, or legal requirements.
6. Pharmaceutical companies that need to retain samples for regulatory compliance, stability testing, or future reference.
7. Forensic science laboratories that retain samples as evidence for legal proceedings or further analysis if necessary.
8. Any industry or organization that deals with testing, analysis, or requires sample preservation for future reference or verification.

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What is reference and retention samples?

Reference and retention samples are representative samples of a product or substance that are kept for comparison or verification purposes.

Who is required to file reference and retention samples?

It depends on the specific regulations or requirements of the industry, but typically manufacturers, producers, or distributors may be required to file reference and retention samples.

How to fill out reference and retention samples?

Reference and retention samples are typically filled out by documenting the relevant information such as date collected, location sampled, storage conditions, and any specific identifiers.

What is the purpose of reference and retention samples?

The purpose of reference and retention samples is to have a basis for comparison or verification in case of disputes, quality control issues, or regulatory requirements.

What information must be reported on reference and retention samples?

Information such as date collected, location sampled, storage conditions, identifiers, and any relevant details about the product or substance should be reported on reference and retention samples.