Quality control is a fundamental operation of the pharmaceutical business. Drugs must be promoted as safe and therapeutically active formulations whose presentation is predictable and consistent. New and better medicinal agents are being produced at an accelerated rate. Simultaneously more demanding and sophisticated analytical methods are being produced for their evaluation.
Importance:
Quality control of products bears unmistakable advantages for all – regardless of whether producers or consumers. Some of the important advantages of quality control are as follows:
1. The brand products build up image goodwill which ultimately increases sales to 10X.
2. It helps the manufacturers/ entrepreneurs in fixing responsibility of workers in the production process.
3. Quality control also helps in minimizing costs by increasing efficiency, standardization, working conditions, etc.
4. It also enables the entrepreneur to know the cost of his / her product quite in advance which helps him in determining competitive prices of his product.
5. Last but not the least; the entrepreneur can confirm whether the product manufactured by him/her is in accordance with the standard set by the Government. It further facilitates the entrepreneur to take necessary actions to comply with the standard set.
3 Key approaches to quality control
Here are three key ways to help you ensure you develop a strong, patient-centric control strategy:
1. Combine control strategy with GMP
The control strategy can likewise be combined with the GMP design strategy for front-end studies. This manufactures the foundation for the conceptual design of another expansion or improvement of a production line or facility.
Actually, it is hard to propose an appropriate design without a control strategy. This is because it gives a systematic and organized way to the design, including GMP aspects and regulatory desires. Furthermore (circling back to the patient) it gives a more strong base for client decisions and decreases the risk of having to invest altogether more at a later stage – especially when it turns out to be clear which products will be manufactured in the facility or at the new line, and how.
A control strategy evolves all through the product lifecycle. It is product-specific during submission, yet after scale-up and technology transfer and not long before process performance qualification or process approval, it grasps facility, utility, equipment, process automation controls and other GMP controls.
It even incorporates business-oriented controls, including yield, overall equipment effectiveness, production lead-time, wastewater, operator protection, energy consumption, and environmental controls. Often, this control sort of strategy is called, ’Manufacturing Control Strategy’ or ‘Production Control Strategy’.
2. Put the patient first
Control strategy begins with the patient and ought to consistently be established during development with the patient in mind. A Quality by Design (QbD) is a deliberate process to produce Robust processes with the help of Quality Risk Management (ICH Q9). It is imperative to control the “Variability” of Raw materials just as in Manufacturing process by recognizing Critical Quality Attributes (CQA) / Critical Material Attributes (CMA) and Critical Process Attributes (CPP) through Risk Management process. It assists with having a better understanding of Process & Product along these lines helping Life Cycle Management of the product (LCM). It should:
• Establish a quality objective product profile with related basic quality attributes.
• Identify the material attributes and critical process parameter.
• Outline how the process ought to be worked and controlled to ensure the product is of the right quality, the expected quality target and critical attributes.
• And at last, the control strategy utilized for commercial production must be approved by healthcare specialists and reflected in the masterbatch records and standard working procedures.
Advantages of QbD to the Generic Industry
• A better understanding of the procedure and the product.
• Minimum batch failures.
• A better understanding of the dangers involved & mitigation.
• Minimising variations to accomplish consistency in manufacturing quality.
• An enhance QbD way to deal with pharmaceutical development gives chances to progressively adaptable regulatory approaches for instance: Manufacturing changes within the approved design space can be without regulatory review or approval.
• Reduction of post-endorsement submissions.
• Greater regulator confidence of powerful products.
• Innovative Process Validation methods.
• More drug accessibility and fewer reviews from the market.
• Improved yields, fewer investigations, reduced testing, lower cost, and so on.
• The timely launch of products.
• Right first time & each time concept.
• Real-time Release thru PAT implementation.
• Cost savings/ Return on investment.
• More effective technology transfers.
A patient-centric control strategy is an establishment for designing a manufacturing facility and production line. This is valid for: conceptual process and facility design studies, equipment and facility qualification, process performance qualification, defining user requirement specifications, process validation, continued (ongoing) process verification program, just as the everyday manufacturing and control program.
When is a patient-centric control strategy defined?
You should define the patient-centric control strategy during product development and process design. It should concentrate on accomplishing the right basic quality attributes by controlling critical process parameters and material critical quality attributes, frequently done on a lab scale.
When the process is scaled-up and moved to a commercial site, you ought to expand it into an operational-oriented production control strategy utilizing a cross-functional team, remembering subject matter specialists in engineering, development, technical support, quality assurance, production, automation and IT.
3. Focus on production in the control strategy
The production control strategy is exceptionally complex as it reflects process understanding. Be that as it may, if it is built up utilizing a systematic science and risk-based approach, you can utilize its full potential for other activities when increasing the facility and preparing it to produce products.
A Production control strategy to act as an input and definition for the masterbatch records, the batch execution system and the process control system. However, it is likewise valuable to define the continued ongoing process verification, for smarter and leaner qualification, for process automation projects, and validation programs, and lastly, for continual improvement activities.
A robust production control strategy, dependent on process understanding, implemented in business operation minimizes the danger of compromising product quality and process robustness. It assists to address deviations, improve in general management, and means continuous improvement can be proactively proposed. Also, improvement opportunities drive lifecycle management activities – profiting both the patient and the business.
We at JoinHub Pharma concentrate more on Quality control and Quality Assurance as these are our strengths and the key differentiators. We have EU GMP certified plants in India to guarantee that products are reliably manufactured to a quality suitable for consumers intended use.
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