The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s body responsible for the assessment of quality and safety of medical devices, has published an official notice dedicated to the updated rules of manufacturing medicines and medical devices.
The updated rules were introduced by the virtue of the Order of the Minister of Healthcare of the Republic of Kazakhstan dated December 20, 2020, in accordance with the Code of the Republic of Kazakhstan “On public health and healthcare system”. The new version of the medical device manufacturing rules actually replaces the previous one dated April 22, 2019, and takes effect in 10 business days from the date of the first announcement.
Regulatory Background and General Provisions
The updated rules prescribe the regulatory requirements for the manufacturing of medicines and medical devices by the entities holding the establishment license required to conduct such activity. In particular, the document provides rules to be followed by pharmacies and medical device stores
The new rules provide the definitions of the core terms used in the context of manufacturing medical devices including, inter alia, the following ones:
- Manufacturing medical devices – a pharmaceutic activity related to the manufacturing of medical devices in pharmacies, medical device stores, and optic stores,
- Good manufacturing practice – the national standard in the sphere of circulation of medicines and medical devices, establishing the requirements for the organization of manufacturing, manufacturing process, and quality assessment in the context of manufacturing medicines and medical devices.
- Cross-contamination – contamination of source material, intermediate product of final product by another source material or product in the process of manufacturing or storing.
- Sterile medicines – the ones manufactured in the appropriate form and passed sterilization process ensuring the absence of live organisms.
Under the general rule, the manufacturing process should be based on the regulatory requirements set forth by the State pharmacopeia of the Republic of Kazakhstan, separate articles of pharmacopeia, foreign pharmacopeias recognized to be valid on the territory of the Republic of Kazakhstan, as well as other regulatory documents.
The new rules additionally emphasize that healthcare institutions that have no pharmacy allowed to manufacture medicines in their structure should not manufacture medicines, change packaging or labels.
Medicines Manufacturing Process in Brief
The new rules actually constitute a combined document addressing the aspects related to manufacturing both medicines and medical devices. Section 2 of the new rules address the manufacturing of medicines, while Section 3 describes in detail the rules to be applied with regard to manufacturing medical devices.
According to the new rules, the process of manufacturing medicines should be based on the following principles:
- Conformity with the prescriptions indicating the doses in accordance with the age of the patient,
- Compliance with the manufacturing technologies,
- Ensuring the appropriate labeling,
- Ensuring that the patients are duly informed about the use conditions.
The manufacturing of medicines could be conducted upon the prescription of healthcare professionals, upon request of healthcare organizations, and also in the context of creating internal reserves. The deviations arising the course of the manufacturing process should not exceed the appropriate thresholds set forth by the applicable regulations.
The updated manufacturing rules additionally emphasize that the medicines manufactured in pharmacies could be supplied only to the responsible person of the healthcare institution against the appropriate authorization documents provided.
The rules also outline the list of medicines to be manufactured in aseptic conditions. Such medicines include, inter alia, the products for neonates, irrigation substances, liquid medicines for neonates, concentrated substances, as well as ophthalmic products.
The manufacturing process should be based on the information on the chemical compatibility of the components used, technologies, and sterilization regime. The simultaneous manufacturing of several sterile substances containing medicines with various components or concentrations in a single workplace is strictly prohibited. For sterile products, the control for mechanical inclusions should be conducted before and after sterilization.
Medical Device Manufacturing Process
The new rules highlight the main aspects to be considered, namely:
- The medical devices shall remain safe and do not expose patients or users to additional risks when being used for the intended purpose and in accordance with the instructions and information provided by the medical device manufacturer.
- The features of medical devices should remain intact during storing and transporting.
- The risks associated with infecting patients and cross-contamination should be reduced to the lowest extent possible.
The technical characteristics and functional features of medical devices should not decline within the whole life term of the medical device specified by the manufacturer. They should not be affected by the impact of external factors, and shall not expose the health and safety of the patients and users to additional risks when being used in the appropriate environment in accordance with the operation manuals supplied with the medical devices.
Medical devices intended to be used together with medicines should be compatible with such medicines in accordance with the functional features of such medical devices, as well as the use and storing conditions of the medicines used.
The manufacturing of medical optics should be performed using the equipment initially intended to work with the optical lenses in accordance with the prescriptions related to the particular patient. The verification of the accuracy of the lenses manufactured should be conducted by using the appropriate equipment together with the patient (client) to ensure the lenses meet the requirements indicated in the prescription.
Additionally, the updated rules on the manufacturing of medicines and medical devices provide the templates of internal documents to be used by pharmacies and other entities engaged in the manufacturing process for the purpose of record-keeping. In particular, the annexes to the new rules include:
- Allowed deviations with regard to manufacturing medicines in pharmacy;
- Allowed deviations for measuring the acid-alkaline balance;
- The rules for sterilization, storing, and expiry dates for medicines manufactured in pharmacies;
- The template of a journal for registration of the control results for separate manufacturing stages;
- The template of a journal for sterilization regime for source medicines, manufactured medicines, ancillary materials, and equipment.
Summarizing the information provided here above, the present rules prescribe the approach to be applied by pharmacies and stores entitled to manufacture medicines and medical devices. As was already mentioned before, the appropriate establishment license is required for the entity to be allowed to conduct such an activity. The updated rules outline the regulatory requirements to be followed in order to ensure the quality of products and the safety of patients and customers using them. According to the rules, medical devices should meet the applicable safety requirements within the whole life term, providing they are stored, transported, and used strictly in accordance with the instructions for use and operational manuals supplied by the manufacturer.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
Sources:
