The new article describes in detail the good assembly practice principles to be applied for medical devices and also provides additional clarifications regarding the traceability-related matters to be considered.
The Health Science Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the application of Singapore Standard Good Distribution Practice for Medical Devices. The document describes the approach to be applied by the parties involved in the distribution and supply of medical devices allowed to be marketed and used in the country and also provides additional clarifications and recommendations regarding the current regulatory framework the parties involved should consider. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. Furthermore, the recommendations provided therein could be subject to changes, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to good assembly practices.
First of all, the document states that the online control to be performed during packaging should cover the following:
- The general appearance of packages;
- Completeness of packages:
- Correctness of products and packaging materials used; and
- Correctness of over-printing, e.g., batch number, shelf life/expiry date.
Once the packaging operation is completed, any materials contacting batch codes that haven’t been used should be destroyed (this procedure should be duly documented). Should any significant discrepancy be identified in the course of subsequent reconciliation (concerning the number of devices manufactured and packaging materials printed), such a discrepancy should be subject to a rigorous investigation. All such operations should be carried out strictly following the documented procedures to be developed and implemented by the party responsible for the device. The authority also mentions that where any packaging process validation applies, the study should be carried out following predefined and authorized protocols.
The guidance also addresses the aspects related to the equipment used to assemble medical devices. According to the document, the equipment should be appropriate to ensure the final product meets the applicable specifications. If the equipment to be used is new or was subject to significant modifications, it will be also necessary to verify that it meets the respective specifications and could be used for the intended purpose.
As further explained by the HSA, line clearance should be performed before the commencement of assembly activities. This includes special checks to be conducted and duly documented. The scope of such checks covers, inter alia, the following aspects:
- The equipment and workstation are clear of previous products, documents, or materials not required for the planned process, and
- The equipment is clean and suitable for use.
Unique batch numbers should be assigned to each batch of products manufactured. The authority recommends performing labeling straight after packaging and sealing. The party responsible for the process should duly implement the measures preventing mix-ups or mislabelling.
The document also pays attention to printing operations which should be subject to additional checks and controls. For instance, printing by hand should be subject to checks to be conducted regularly. The information printed should be placed in a way ensuring it remains visible.
A party responsible for a medical device should appoint a person to be responsible for releasing the products manufactured. It is further stated that if sampling of the final finished pack is performed, the samples taken should be done under approved written procedures that describe:
- Method of sampling;
- Equipment to be used;
- Quantity of samples to be taken;
- Special storage condition for the samples taken, if applicable; and
- Recording of the results of in-process control.
The scope of the guidance also covers the aspects related to the measures to be taken to ensure the traceability of medical devices supplied. As explained by the HSA, it is important to ensure the device is tracked within the whole supply chain from manufacturer to end-user – this will become especially important in case of field safety corrective actions are to be taken to ensure the safety of the device and public health protection. This is also important in terms of investigation of quality-related problems, as well as identification of medical devices that are not compliant with the applicable regulatory requirements. For this purpose, batch/lot/serial numbers could be used, allowing the identification of a specific medical device and ensuring end-to-end traceability.
As further explained by the HSA, records providing traceability main include delivery orders from the supplier, distribution or sales records, returns and disposal records, etc.; to facilitate traceability, the records should include the date, lot/batch/serial number, quantity, name of medical device, address of the supplier and customer. Concerning distribution records, requirements they should meet, and additional aspects to be taken into consideration in this respect, the authority refers to the respective guidance document – GN-06: Guidance on Distribution Records for Medical Devices, which is available on the official website of the authority.
In summary, the present HSA guidance outlines the key points to be considered concerning the medical device assembly process, including the aspects related to the equipment used, labeling, and ensuring compliance with the applicable product specifications. The document also describes the approach to be applied for the measures to be taken to ensure traceability of medical devices within the whole supply chain from the manufacturer to the end-user, as this is vitally important in terms of potential field safety corrective actions and other activities related to post-market surveillance.
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