Pharmaceutical Manufacturing Uncategorized

How to control the quality parameters in pharmaceutical manufacturing?

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.

Contact the best pharmaceutical medicine supplier today!

Pharmaceutical Manufacturing

How to choose the right pharma contract manufacturing company from India?

There is no denying that that pace and amount of contract manufacturing in the pharmaceutical industry has grown significantly over the last couple of years. There are numerous reasons why pharmaceutical companies decide to outsource or contract out their manufacturing activities. JoinHub Pharma deals in Third party pharma and contract manufacturing in India. Each and every manufacturing is done in our company-owned WHO-GMP certified units. A recent Frost and Sullivan report on outsourcing in the pharmaceutical industry referred to the following factors as some of the main reasons why pharmaceutical companies choose to outsource:

• Outsourcing can decrease overall expenses by 30% to 35%
• Faster and less expensive to have discovery work outsourced, decreases drug development cost
• Reduces problems faced during the regulatory processes around the globe
• Improves producing efficiencies
• Reduces excess production limit by divesting facilities
• Minimizes investments in capital-intensive facilities
• Improves net earnings and income
• Diverts resources to concentrate on different competencies like marketing

The report additionally states that outsourcing can permit pharmaceutical companies to establish consistency and proficiency across the sprawling supply chain, international networks of commercial, and manufacturing organizations and, whenever managed and executed strategically, can possibly add to shareholder value and keep the investment community happy. No small accomplishment in this time of economic turmoil.

Contract Manufacturing Market Size
The ever-increasing expenses of R&D combined with poor bottom lines and low productivity has constrained many pharmaceutical companies to outsource both research and development and manufacturing activities to low-cost nations, thereby saving expenses and time in the process. With increased activity in outsourcing, the worldwide market for such services has grown from roughly $57.2 billion in 2007 to an expected $76 billion this year. India, with a large share of US FDA-approved manufacturing facilities, is one of the most-liked locations for outsourcing manufacturing services.
Be that as it may, with outsourcing come concerns. Many pharmaceutical firms often managing long-distance and confused collaborative third-party relationships and afraid of losing control in proprietary knowledge and procedures, and delays because of regulatory hold-ups and imperfect processes.”

Certification
All Pharma Manufacturer must be WHO-GMP certified Manufacturer and few is WHO or equivalent Regulatory approved. One can’t hope to get 500 or 1000 boxes made from WHO-approved plants as there is not much statutory compliance that has to adhere, for small batches consider EU GMP certified Manufacturers.

Product Portfolio
Choosing a company with an extensive product portfolio is significant. Some Pharma Companies don’t offer a wide range of products which implies your rivals may have the edge over you and would have a superior possibility of converting a doctor. JoinHub Pharma provides over 1000 Products in different therapeutic segments which will help you in getting ahead of other PCD Pharma Companies.

Delivery
Maintaining the timeline is very important ordinarily it takes around 30-45 days for delivery of the first batch of products and on repeat order 30 days. Anyway, it might differ by not many days here and there. Kindly note the days referenced is after the design is approved not when the PO is raised.

Rates
It’s very hard to find the Manufacturer with lowest rates however for this it is suggested to contact multiple vendors to pick the best. Rates are directly proportionate to the Raw material which is fluctuating nowadays subsequently its advisable to place the order within 7 days of negotiations otherwise there are chances that when you will place the order the rates are changed because of the changes in the Raw material cost.

Agreement
Most of the Pharma contract manufacturer now requires an agreement with the marketing organization one regarding Trade name of the product, Marketing firms need to give an affidavit to the manufacturer that the Trade name of the brand under production has a place with the company and it reimburses the manufacturer in case of any trade name related issues.

Choosing a CMO
To discover more about the issues that face the industry when considering contract manufacturing, JoinHub Pharma recently finished a survey on “Choosing the Right Contract Manufacturer” We asked you, our readers, what particular qualities and capabilities you search for in a contract manufacturer. The survey results are printed here, yet some fascinating takeaways include:
• 60% of respondents intend to utilize the services of a CMO in the following year and a half.
• Particular product experience and cost were referred to as the two most significant CMO characteristics.
• Nearly 75% of all respondents would not hesitate to pick a CMO not based in their own nation.
• Expertise with a given application or service is the main explanation used to choose a CMO.
• Reputation is everything, and a poor reputation is the kiss of death for a CMO; FDA cautioning letters don’t help either.
• Confidentiality is significant. A history of being discrete with numerous customers is a prime CMO determination factor.
• With international regulatory agencies expanding their scrutiny on CMOs, respondents referred to finish cooperation during a recall as a significant CMO attribute.

These are a few factors that can assist you in choosing the Best Pharmaceutical Manufacturer in India. For more updates on pharma contract manufacturing company in India and how we can help you, please contact our team.

CALL ME BACK