Production produce devices for control and regulation of technological processes
Safety and quality are non-negotiables in the medical devices industry. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. It has recently been revised, with the new version published in March ISO A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.
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A further implied aspect which is not as evident in the definition, is the possibility that the transfer also includes a scale-up to a larger batch size. This is very common during the different stages of the development of a pharmaceutical product and particularly as the drug development moves through to the manufacture of the first commercial-scale batches.
There are a number of activities involved in a tech transfer, including development and manufacturing transfer, the transfer of analytical methods, and necessary skills assessments and training. The planning and management of the transfer is also key—as is the assessment of facilities and equipment, documentation, and, finally, qualification and validation. All of these transfer activities involve several, if not all, departments within each of the participating companies.
All this makes it essential that there is a project lead to coordinate the activities and departments involved. Any manufacturing process transfer needs analytical support to guide its progress.
Similarly, it is also necessary to know the regulatory implications of the transfer activities. Regulatory requirements in the countries of the sending unit SU , or manufacturing plant transferring the technology, and the receiving unit RU , or manufacturing plant receiving the tech transfer, and in any countries where the product is intended to be supplied, should be taken into account.
There are no regulatory limitations in case of investigational medicinal products IMPs , except if there is a change of manufacturer affecting an ongoing clinical trial. Once the pharmaceutical product is granted marketing authorization MA and becomes a medicinal product for human use, the MA holder has the responsibility to manufacture, control, and market the drug product according to the conditions and requirements described in the documentation submitted and approved by the Health Authorities.
Any change in that documentation has to be evaluated and notified to the Health Authorities according to EU laws and regulations. A product transfer between manufacturing plants is considered a modification in the manufacturing site of the finished product section B. A case-by-case assessment will be required to determine if additional documentation over the requirements of the previous section is necessary.
The purpose of the documentation is to prove that, despite the change of manufacturer, the drug product will continue to meet the quality, safety, and efficacy requirements that allowed it to receive the MA. In order to ensure the authorized therapeutic effect, the product must meet the quality specifications, remain stable, and its bioavailability must be equivalent. In every manufacturing process transfer, there are two key teams.
On the one hand, the technical team of the SU, which has the knowledge of the product and process to be transferred critical steps, critical quality attributes—CQAs—and critical process parameters—CPPs, etc.
On the other hand, the technical team of the RU has knowledge of the available technologies and equipment at the receiving manufacturing plant. The key for a successful transfer lies in the coordination, alignment of goals, and understanding between both teams.
Every manufacturing process that is transferred has an inherent or residual variation and produces a finished product with certain specifications and specific CQAs. The goal of a successful transfer is to ensure that this residual variation is not negatively affected by factors such as the usual changes in materials, equipment, methods, personnel, and environmental conditions.
This means that the product is able to maintain the same quality it had in the SU. The transfer must be based on a risk analysis of each one of the previously described factors, and other less obvious aspects should not be forgotten, such as the HVAC system and containment level.
Although less critical, these can occasionally have a relevant influence on the product or can impact the safety conditions for the operators. A common process transfer plan should start with a protocol written jointly by the SU and RU and should include:. Other available documentation, such as process validation and pharmaceutical development reports etc.
However, it is recommended to check if they comply with current regulatory requirements at the time of the transfer. In addition, the raw materials excipients and packaging material used may have an impact on the final product. Therefore, an evaluation of the raw materials proposed by the RU should be conducted. The simplest option is to use identical raw material references to those used by the SU. However, this is not always feasible.
From an economic standpoint, it is not desirable to increase the number of references of the basic same raw material in the RU; however, at the same time, it must be ensured that there is no impact on the CQAs of the product. The raw material specifications should be thoroughly reviewed, identifying the differences. There is always the option to perform confirmatory testing during the transfer.
There are other variable aspects that can be modified or adjusted at the tech transfer stage in order to obtain a product within specifications, such as the correct selection of equipment, the determination of process parameters and its control strategy. Therefore, knowledge of the available technologies and equipment at the RU is critical.
After the selection of materials, facilities, and equipment, it is necessary to assess the training needs of the RU personnel, based on objective criteria of their knowledge of the technology being transferred. There is no be-all and end-all single process transfer. Every transfer has to be analyzed and planned from scratch, assessing the best way to carry it out, while minimizing risks. At the end of every transfer, there must be a report describing, among other aspects, the raw materials and equipment used, the detailed manufacturing process, the process parameters, and the control strategy.
The transfer is not the end goal per se, but the path to manufacture the pharmaceutical product in a different plant. The aim is to have documented proof that the transferred manufacturing process can be validated and the product can be routinely manufactured at the RU. Documentation: Any evidence of a successful transfer should be properly documented. Technology Transfer: Key Considerations There are a number of activities involved in a tech transfer, including development and manufacturing transfer, the transfer of analytical methods, and necessary skills assessments and training.
Regulatory Considerations Any manufacturing process transfer needs analytical support to guide its progress. Ensuring Successful Process Transfers In every manufacturing process transfer, there are two key teams. A common process transfer plan should start with a protocol written jointly by the SU and RU and should include: Objectives, scope, personnel, and responsibilities Raw material specifications, including supplier and manufacturer details Equipment and facility requirements of the SU Detailed manufacturing process from the SU Health, safety, and environmental issues Critical points CQAs and CPPs Sampling points Acceptance criteria Change control and retention samples Other available documentation, such as process validation and pharmaceutical development reports etc.
The raw material specifications should be thoroughly reviewed, identifying the differences and assessing their potential influence on the CQAs of the product, based on a risk analysis. A logical sequence for each of the transfer trials in the RU would be: Definition of intermediate output material CQAs and CQAs per manufacturing step for instance, particle size distribution and density in the granulation step Identification of CPPs and establishment of values for the RU Experimental and documented execution of each trial Assessment and comparison of intermediate output material CQAs and CQAs per manufacturing step SU vs.
RU Conclusions and next steps Useful Tools There are a number of tools that can be very useful during a process transfer, including: Ishikawa diagrams: This is a brainstorming tool to identify factors that could potentially impact product quality and to investigate the process to be transferred materials, process parameters, equipment, etc. Risk analysis: The parameters or factors defined above should be reviewed against the CQAs of the product.
The risk level should be established, along with a valid justification of the classification. For instance, the influence that the density of the granulate has on the blend flow is well known, as is the influence of the latter in the mass variability of a tablet.
Design of experiments: This is a systematic method to determine the relationship between factors affecting a process and the output of that process. It will also help to establish the residual variation of the transferred process, estimate interactions between factors, and, above all, define and understand the design space of the manufacturing process in the SU.
Process capacity: Every process has an inherent variability that can be assessed with statistical methods. It is recommended that the transfer teams perform statistical calculations of the number of units that will be manufactured out of specifications in order to confirm the capacity of the process.
Dimensional analysis: This helps to simplify the study of any single phenomenon, even if it depends on many physical magnitudes, as independent variables. It involves finding adimensional numbers Reynolds, Froude, Newton, etc. The value of these numbers remains constant regardless of the scale or place of manufacture and may help to set process parameters in the SU.
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Regulatory Control is the Foundationfor Advanced Process Control
Griffith Uni ranks in the top 2 percent of universities globally with 50, students spanning six campuses in South East Queensland, Australia. A low stock turn rate means you're. The system engineering process part describes how the system engineering process applies to program requirements. Search for jobs hiring in your area using ZipRecruiter's job search engine - the best way to find a job. First Research Industry Profiles. One of the most difficult decisions in planning is to know when to pull the plug on a project. General Summary: Our dynamic microelectronics factory is looking for a Production Planning and Material Control professional who is hands-on and capable of managing production planning, scheduling, and inventory utilizing a modern ERP system. However, these improvements are often.
ISO 13485 Medical devices
A further implied aspect which is not as evident in the definition, is the possibility that the transfer also includes a scale-up to a larger batch size. This is very common during the different stages of the development of a pharmaceutical product and particularly as the drug development moves through to the manufacture of the first commercial-scale batches. There are a number of activities involved in a tech transfer, including development and manufacturing transfer, the transfer of analytical methods, and necessary skills assessments and training. The planning and management of the transfer is also key—as is the assessment of facilities and equipment, documentation, and, finally, qualification and validation. All of these transfer activities involve several, if not all, departments within each of the participating companies.
D one of the more salient requirements of the regulation. In fact, the FDA has frequently focused their efforts on production and process controls during their friendly visits. Similar to design control, the requirements for production and process controls are substantial, so it is not possible, nor could Dr. D lend credence to the material by attempting to cover the requirements in just a single edition of Devine Guidance DG.
Industry 4. Industrie 4. The goal is to enable autonomous decision-making processes, monitor assets and processes in real-time, and enable equally real-time connected value creation networks through early involvement of stakeholders, and vertical and horizontal integration. Most Industry 4.SEE VIDEO BY TOPIC: Medical Device Design Control
Line has worked in the pharmaceutical industry, both in pharmaceutical development and product manufacturing, for the last 20 years. Line is experienced in pharmaceutical development using a science and risk-based QbD approach. She has worked with different innovator and generic clients implementing QbD strategies, QbD programs, QbD tools, advanced control strategies based on real time release and QbD-based regulatory submissions of new product applications MAA. She has also been part of a team developing, submitting and gaining approval for an oral solid dosage formulation based on QbD, design space, PAT and full real-time-release testing. Line was one of the pioneers who, together with the FDA, EMA and the ASTM standard organization, helped to develop the science and risk-based framework - the new foundation for product development and manufacturing in the pharmaceutical and biotech industry.
W ant top-notch advanced process control? Get the basic regulatory control right, first. It is upon this foundation that effective advanced process control APC can be constructed. Maximizing return on investment ROI is always an important goal of plant management. However, purchasing control equipment, transmitters, and a digital control system loaded with the latest advanced control software does not guarantee good control. If not managed, understood, and optimized to match control objectives for which these purchases were made, the ROI is poor. Process control systems convert raw materials and energy into usable products through an intricate series of processing steps and control techniques. For a plant to produce high quality product at the least costs requires a structure of people, systems, and facilities integrated together and built on a foundation of management commitment.
The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. Definitions of words and terms. Improper business practices and personal conflicts of interest. Administrative matters. Competition requirements.
Not a MyNAP member yet? Register for a free account to start saving and receiving special member only perks. Manufacturing process controls include all systems and software that exert control over production processes. Control systems include process sensors, data processing equipment, actuators, networks to connect equipment, and algorithms to relate process variables to product attributes.
This blog provides a comprehensive guide for Medtech professionals to design and develop effective medical devices. A medical device design that adds value to end user and simultaneously captures profitable market share is really a tough job. Is it because healthcare is a life-critical segment? Or is it because it involves complex procedures?
The concept actually aims at understanding the processes by defining their CPPs, and accordingly monitoring them in a timely manner preferably in-line or on-line and thus being more efficient in testing while at the same time reducing over-processing, enhancing consistency and minimizing rejects. With this framework — according to Hinz  — the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the time of conducting phase-2 clinical trials. PAT is a term used for describing a broader change in pharmaceutical manufacturing from static batch manufacturing to a more dynamic approach. It would be acceptable to consider that raw materials used to manufacture pharmaceutical products can vary in their attributes e.
An effective quality system takes a total systems approach to satisfy safety, effectiveness, and performance requirements. Quality should be considered at all stages of production, starting at the earliest stages of product design. To ensure that finished devices will be safe and effective, current Good Manufacturing Practice cGMP requirements govern the facilities and controls used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all medical devices. Vinny Sastri, President of Winovia LLC, who highlighted some of the key elements of effective production and process controls. We present some excerpts below.
With the global mandate to make healthcare more accessible, affordable and wirelessly connected, medical and life sciences OEMs look to their strategic outsourcing partners more than ever to co-create revolutionary advancements in technology that lower costs and improve outcomes — all without compromising quality and traceability. As the Internet of Things IoT continues to drive astounding breakthroughs in healthcare, patients are becoming more mobile, aware and self-sufficient in their care, while professionals enjoy easier access to data. Creation delivers proactive design and manufacturing innovation across these healthcare fronts, and more, all while meeting stringent regulatory requirements for ensuring product accuracy and patient safety. Creation protects your IP through secure business systems and information technology that is segregated within the production environment through a cellular manufacturing model.