The Tanzania Medicines & Medical Devices Authority (TMDA), the country’s regulating authority responsible for healthcare products, has published a draft regulation on good storage and distribution practices with regard to medicines and medical devices.
The present draft Tanzania Medicines and Medical Devices (Good Storage and Distribution Practices) Regulations outlines the applicable regulatory controls with regard to the storage and distribution of healthcare products subject to state regulation.
First of all, the new regulation provides the definitions of the most important terms to be used in the context of the regulatory matters addressed in the document including, inter alia, the following ones:
- “Batch” means the quantity of products processed in a single process or series of processes so that it is expected to be homogeneous,
- “Distributor” means a person who buys products from importers or local manufacturers and who sells in bulk or wholesale to retailers and includes importers,
- “Good storage practices, GSP” means that part of quality assurance that ensures that the quality of products is maintained by means of adequate control through the storage thereof,
- “Manufacturer” means a person or a firm that is engaged in the manufacture of regulated products,
- “Regulated products” mean human medicines, veterinary medicines, biologicals including vaccines, biocidal including antiseptics and disinfectants, herbal medicines, medical devices, diagnostics, medical laboratory equipment, and investigational products,
- “Storage” means the storing of products up to the point of use,
- “Supplier” means a person or entity engaged in the activity of providing products or services.
The new draft regulation on storage and distribution also describes the general principles the new regulatory approach should be based on. In particular, the entity engaged in the aforementioned activity should achieve and sustain compliance with any and all requirements set forth under the present draft regulation. Moreover, any entity participating in operations with medical devices shall take all the steps necessary to ensure that the quality of regulated products, including medical devices, is maintained within the whole supply chain from the medical device manufacturer to the healthcare professional or patient using the device. The rules set forth therein should be also applied in case of “backward movement” – e.g., in case of withdrawal or similar actions. Another important principle states that medical devices as regulated products should be procured from and supplied to the entities having the necessary authorization to carry out the appropriate type of activity.
Requirements on Premises
One of the most important matters addressed in the new draft regulation relates to the premises used to conduct operations with medical devices including:
- Manufacturing facilities,
- Importing wholesalers,
- Institutional pharmacies,
- Veterinary practice facilities,
- Medical laboratory facilities, and
- Any other premises as designated by the regulating authority.
Consequently, according to the new rules, the owners of the aforementioned premises should achieve and sustain compliance with the applicable requirements set forth therein.
The draft regulation describes the requirements the premises intended to be used for the storage and distribution of medical devices should meet. These requirements include, inter alia, the following ones:
- General technical aspects – the premises should be secure and safe,
- Lighting – it is important to ensure the lighting is sufficient to carry out the operating activities,
- Physical security – it is necessary to introduce the measures preventing unauthorized access,
- Division – the premises should be divided into the appropriate sections depending on the type of the products.
The regulations also describe additional measures to be implemented in order to ensure safety when carrying out the activities related to the storage and distribution of medical devices in terms of maintaining the quality of medical devices.
Delivery and Acceptance of Medical Devices
Moreover, the regulation describes some of the procedures to be performed when receiving a consignment of medical devices or other healthcare products. In particular, it is necessary to check whether the medical devices actually delivered meet the specifications indicated in the supporting documentation. The regulation states that it is necessary to ensure that the correct product is delivered from the correct supplier. For this purpose, the receiving party may use purchase orders, label descriptions, or various certificates (e.g. certificate of analysis or certificate of conformity) supplied with the medical devices received or provided separately by the manufacturer or supplier. The regulation additionally emphasizes that in case if a consignment received consists of more than one batch, each of the batches should be treated separately, especially in terms of sampling – according to the draft regulation, the samples should be taken from each batch. When checking, the responsible person of the receiving party shall also pay special attention to the transportation conditions. It is necessary to ensure that the appropriate requirements with regard to the temperature and humidity are fulfilled, otherwise, this could impact the safety and performance of medical devices. For this purpose, a responsible person shall check the transportation temperature data.
Upon acceptance, the medical devices and other healthcare products should be stored strictly in accordance with the requirements indicated by the manufacturer in order to ensure their continuous quality. The products should be stored in a way preventing the impact caused by external factors, such as sunlight. Additionally, the owner of the premises shall sustain continuous compliance with the requirement regarding the premises themselves, their state of cleanliness, and overall condition.
Quality Management System
Another aspect described in the document is the approach for quality management. According to the document, the owner of the premises used to conduct operations with medical devices shall duly implement the quality management system based on the principles set forth therein. In particular, the quality management system to be implemented by the owner of the premises shall cover the following aspects:
- The appropriate organizational structure with defined responsibilities of the personnel recorded as job descriptions,
- Competent personnel,
- Suitable and sufficient premises, equipment and facilities, and
- Written and approved procedures for all activities.
Additionally, the owner of the premises as a responsible party shall identify the risks arising in the supply chain and implement the measures and controls necessary to mitigate them. The evaluation of such risks should be based on the current level of scientific knowledge and experience. In the course of such activities, the owner shall also conduct periodic reviews of the effectiveness of the controls introduced. In particular, the periodic management review to be employed by the owner of the premises shall include the evaluation of the effectiveness of the existing quality management system, assessment of the improvement opportunities, and also the follow-ups with regard to the recommendations provided in the course of the previous reviews. In order to ensure transparency, all documentation related to the matters outlined hereabove should be provided to the regulating authority upon request.
Summarizing the information provided here above, the new draft regulation on good storage and distribution practices with regard to medical devices and other healthcare products subject to state regulation describes the most important aspects to be considered by the parties involved. In particular, the provisions of the new draft regulation describe the requirements related to the premises intended to be used to carry out the operations with medical devices and also address certain procedures to be performed by the responsible parties.
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