1.0 Purpose:
The purpose of this SOP is to establish a standardized protocol for the retention of raw materials utilized in laboratory and manufacturing processes. This procedure is aimed to ensure the identification, traceability, and timely retrieval of these materials in the case of any need for testing, re-examination, or re-validation.
2.0 Scope:
This procedure applies to all raw materials used in the production and testing of biopharmaceutical products. It covers the retention of samples from incoming materials, intermediates and final products by the manufacturing unit.
3.0 Responsibility:
It is essential to maintain the traceability of raw materials and meet various regulatory guidelines. Therefore, it is the responsibility of all laboratory technicians, scientists, and manufacturing personnel to ensure compliance with this SOP. The Quality Assurance and Control Department should also ensure that the monitoring of the retention of samples is performed correctly.
4.0 Procedure:
1. Identification: All incoming materials and products should be labeled with their name, supplier name, and batch number upon receipt. Each item should have a unique identification number, which should be recorded in the inventory record.
2. Sampling: At least two samples should be taken from each lot/batch. These samples should be representative of the entire material, and one of the samples should be kept for retention. Each Sample quantity should be twice the quantity required for complete analysis as per standard test procedure. For non-homogenous materials, the sample should be taken from various parts of the material.
3. Packaging: The retained sample should be packaged in a moisture-proof, non-reactive material with proper labeling. The package should have its unique identification number, including the name of the material and batch number.
4. Storage: The retained sample should be stored at a controlled temperature and humidity condition to maintain its stability and avoid any possible degradation. The storage location should be recorded in the inventory record.
5. Retrieval: The retention samples should be available for retrieval in the case of re-validation, re-examination, or investigations. The inventory record should have a provision to track the retrieved samples, their usage, and the person responsible for their use.
5.0 Record Keeping:
The following records should be maintained as part of this SOP:
1. Sample identification, collection date, and batch number
2. Sample labeling and packaging record
3. Inventory record indicating storage location and date of stored retention samples
4. Retrieval record, including the reason for the retrieval and the responsible person
6.0 Revision:
This SOP should be reviewed and updated by the Quality Department every two years or if any changes in the process or regulatory guidelines are published.
7.0 Compliance:
Non-compliance with this procedure may lead to a recall of batches, which can lead to significant financial costs for the company. Therefore, it is essential for all employees to be trained and follow this SOP’s instructions at all times.