The new article highlights the main points related to the secondary assembly of medical devices intended to be marketed and used in Australia. In particular, the document addresses the assembly area requirements, storage conditions, and labeling.
The Health Sciences Authority (HSA), an Australian 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 provides an overview of the applicable regulatory requirements, as well as recommendations to be followed to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should it be reasonably necessary to reflect the corresponding changes to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to the secondary assembly of medical devices. In this respect, the authority also mentions that the general manufacturing activities (e.g., sterilization) are not considered to be secondary assembly.
First of all, the authority mentions that the area used for assembly should be appropriate due to its volume. In particular, it is stated that the adequacy of the working space should permit the orderly and logical positioning of equipment and materials to avoid confusion and minimize the risk of a mix-up between different medical devices or their components; segregated areas should be provided for the storage of approved, quarantined, rejected, recalled and returned materials or products. As it was earlier explained by the HSA, the proper separation of medical devices is vitally important to ensure only the devices that meet the applicable requirements concerning quality, safety, and effectiveness are supplied.
The area used for assembly should have the appropriate lighting and ventilation while smoking, eating, and drinking in such areas should be strictly prohibited. In case external conditions could adversely impact the medical devices in question or the process itself, the appropriate controls are to be developed and implemented. The scope of such controls should be determined depending on the importance of the processes and the way they could potentially impact the quality of medical devices.
According to the guidance, any secondary assembly work instructions should include:
- Name of medical device;
- Description of the applicable medical devices for assembly and pack size;
- Complete list of all the packaging materials required for standard batch size, including quantities, sizes, and types, with the code or reference number relating to the specifications of each packaging material;
- Where appropriate, an example or reproduction of the relevant printed packaging materials, and specimens indicating where to apply batch number references, and expiry date of the medical device;
- Special precautions to be observed, e.g., a careful examination of the area and equipment to ascertain the line clearance before operations begin;
- Description of the packaging operation, including any significant subsidiary operations, and equipment to be used; and
- Details of any in-process controls with instructions for sampling and acceptance limits, if applicable.
The authority also mentions that the appropriate records should be duly maintained by an entity involved in the said operations to ensure the traceability of medical devices. In particular, such information could be either included in the batch record or located in other places with the references added to the batch record.
As further explained by the HSA, when performing a secondary assembly, the responsible party should record important information regarding the process itself, as well as the device involved. According to the guidance, such information should include:
- Quantity of raw materials, components, and intermediate products, and their batch number, if appropriate;
- Date of start and completion of different stages of secondary assembly;
- Quantity of medical device assembled;
- Signed results of all inspections and tests
- Designation of the product line used; and
- Deviation from the secondary assembly specifications, if applicable.
The entity undertaking such activities has certain flexibility in choosing the way to keep the records, provided that the records are duly retained and available upon request. In case the data is stored in digital format, it is also important to ensure that the appropriate measures are implemented to prevent unauthorized access to such data. These measures can include, inter alia, the use of passwords to access and modify the data stored. Furthermore, the data stored electronically should be protected by backup transfer to ensure it will be retained within the appropriate period.
The records to be retained should include the batch/lot numbers and identifiers of any medical devices that were subject to secondary assembly, together with the distribution records.
The document also pays special attention to labeling requirements for medical devices that undergo secondary assembly. According to the guidance, the appropriate regulatory requirements should be followed to a letter to ensure the devices in question are easily identifiable. In certain cases, approval is to be provided by the marketing authorization holder and/or regulating authority.
As explained by the HSA, additional controls to be implemented in this respect may include, inter alia, the following ones:
- Performing secondary assembly separately from other operations;
- Using the packaging and labeling of different appearances to ensure the visual distinguishing of the products;
- Reconciliation of usage of labels;
- Wide usage of electronic codes;
- Storing materials, labels, and devices themselves in a way preventing mix-ups with other products.
In summary, the present guidance describes the general principles to be followed concerning secondary assembly. The document outlines the key points related to the way such operations should be conducted, including such aspects as labeling or storing the products, as well as documenting the operations and record-keeping.
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