Knowledge Popularization: Sample Management and Frequently Asked Questions for Medical Device Products

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Abstract：prefaceRegulatory requirements for sample retention of medical device products Refer to the "Quality Management
preface
Regulatory requirements for sample retention of medical device products. Refer to the "Quality Management Standards for Medical Device Production" and on-site inspection guidance principles, the "Regulations on Self inspection Management of Medical Device Registration", the "Guidelines for Verification of Registration Quality Management System", the "Guidelines for Inspection of Beijing Sterile Medical Device Production Quality Management Standards", and the "Guidelines for Key Points of Medical Device Sample Inspection" (Beijing Drug Administration 2016 edition).
 
Sample retention room (area)
Production enterprises should have relatively independent and sufficient sample retention rooms (areas) for storing sample retention. In principle, the storage conditions for retention samples should be consistent with the storage conditions specified for corresponding finished products, semi-finished products, and raw materials. The area of the retention room (area) should be suitable for the production variety and scale.
The sampling room (area) should be equipped with environmental monitoring equipment that meets the requirements of product quality characteristics, conduct regular monitoring, and keep environmental monitoring records.
 
Ratio or quantity of retained samples
Production enterprises should clarify the specific proportion or quantity of retained samples based on the purpose of retention, testing items, and different types of retained samples. The sample size is generally suitable for the purpose, sample size, and testing items of the sample. The proportion or quantity of retained samples should be determined by the production enterprise itself, but the following requirements should be met.
1. Can support at least one quality traceability test;
For sterile products, samples should be kept for each production or sterilization batch;
3. For retention of samples due to new products, new processes, or changes in product expiration dates, the retention amount should be calculated separately and should not affect quality traceability testing.
 
Three retention sample inspection or observation
Production enterprises should conduct regular sample inspection or observation in accordance with the sample retention system, and keep records of sample observation.
1. Production enterprises should clarify the frequency or cycle of sample inspection or observation based on the purpose of sample retention
(1) The sample observation time should not be less than the product's shelf life;
(2) For stability studies, the observation time for retained samples can be appropriately extended and/or the observation frequency can be increased;
(3) For retaining raw materials, production batch factors should be considered, and the observation time for retaining samples should ensure that the traceability requirements of the last batch of products using the same batch of raw materials are met;
(4) If it does not affect the packaging integrity of the retained samples, they should be visually inspected at least once a year during the storage period.
2. Sample inspection or observation items
Production enterprises should clearly define the items, testing methods, and judgment standards for sample inspection or observation, and have corresponding inspection capabilities. The inspection or observation items during the retention period may differ from the inspection or observation items after the retention period expires.
3. Sample retention records
Production enterprises should establish a sample retention ledger, keep records of sample observation or inspection, and generate a sample retention inspection report. Sample observation or observation records should indicate the batch number, observation date, observer, observation results, and other relevant information. The sample inspection report should indicate the batch number, expiration date, inspection date, inspector, and inspection conclusion of the sample.
4. Summary of sample retention situation
After the expiration of the retention period for in vitro diagnostic reagent products, the retention test report should be summarized, analyzed, and archived. Other types of products can also be followed to evaluate product quality and assess the stability of product quality.
5. Handling of special projects
When unqualified testing items are found during the retention inspection or observation process, they should be handled according to relevant regulations and analyzed to find the reasons for the unqualified items. If similar non conformities will occur in this batch of products, they should be handled in accordance with relevant regulations such as non conformities, returns, recalls, etc.
6. Treatment of retained samples
For the remaining samples after the retention period expires, the production enterprise shall handle them in accordance with relevant regulations to prevent unexpected use of the retention samples.
 
Four common questions
What are the basic requirements for product sample retention in medical device manufacturing enterprises?
Medical device manufacturing enterprises should develop a retention management system based on product and process characteristics, clarify the requirements for retention purposes, retention samples, retention ratio or quantity, retention observation, etc., carry out retention observation, and maintain relevant records.
What is the purpose of product sample retention for medical device manufacturers?
Medical device manufacturing enterprises should clarify the purpose of product sample retention based on product characteristics, process characteristics, clinical applications, etc. The purpose of sample retention varies, and the amount of sample retention and observation items will also vary. Common sample retention purposes include the following:
(1) Used for quality traceability of medical device products: Production enterprises can clarify traceability items based on common quality issues, clinical use risks, and product characteristics, such as aseptic performance and physical performance.
(2) Used for traceability of raw material quality in medical device products: For raw materials that have a critical impact on product quality, the production enterprise can keep samples of the raw materials for traceability of performance indicators in the finished product quality or raw material quality.
(3) Used for stability research: When a production enterprise develops new products, processes, or changes product expiration dates, it is used to examine product stability.
In the production process of Class II and Class III medical devices, if a batch of products uses the same raw material in two batches, it will involve mixed batches. However, a mixed batch is difficult to trace the product, and it will also involve a series of issues such as sample retention. If the surplus from the previous batch is not used, the next batch of materials can be directly used, which does not comply with the "first in, first out" principle. Is there a good way to handle this, teacher?
Article 53 of the "Quality Management Standards for Medical Device Production" stipulates that the registrant shall establish a product traceability program, specifying the scope, degree, identification, and necessary records of product traceability. Therefore, regarding the issue of whether different batches of the same raw material can be used for the production of the same batch of products, it is recommended that the registrant based on risk management principles, combined with factors such as the impact of raw materials on product safety and effectiveness, consistency of quality between batches of the same raw material, and after verification and confirmation, Determine the principles for mixed batch use or tail feeding of materials (mixing batch, dosage, sampling inspection, retention, traceability requirements, and batch record review, etc.).
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