Importance of Quality Assessment in Pharma Industry

Quality assessment is one of the most crucial aspects in the pharmaceutical industry. The evaluation of quality and operational excellence of a pharmaceutical organization is an important factor which has a direct impact on the selection of prospective contract manufacturing partners. Bilcare, a prominent name in the pharma packaging industry highlights the essential factors for quality assessment in pharma industry. 

Consistency and good overall structure are the factors which determine the effectiveness and working process of an organization. The management of staff and operational competence are the prime indicators of fundamental performance of the organization. The quality is directly determined by the aspect of sustainability. Robust processes ensure the consistency in quality management. The way an organization handles and resolves deviations & manages their elimination is an indicator of organizational effectiveness. Bilcare highlights the corrective and preventive actions (CAPA) which is a small process for eliminating problems. It involves identifying the problem, analyzing and determining its root cause and ensuring appropriate measures to correct it and document it efficiently. It is important to make sure that the process of CAPA should be comprehensive, correct and preventative. 

The management of deviation data like the defect rate, number of lab investigations, out-of trends etc. directly affects the performance of the company.  The ability to manage and mitigate risk factor through quality systems and operations is important for analyzing the operations and processes of the organization. The defect rate is the top quality metric, thus it becomes important to analyze how effectively the organization manages the defect rate.Importance of Quality Assessment in Pharma Industry

Radiopharmaceutical Packaging and Handling

Radiopharmaceuticals, if handled incorrectly, can compromise exams and consequently the health of many people. With the intention of renewing radiopharma pharma packaging  sought to create vials and boxes that would provide greater safety and traceability, uniting simplicity and objectivity in its design. Following a branding study developed by Brand, the team had the challenge of bringing graphic elements while respecting the national regulations of the segment, in addition to studying the security seals and talking to doctors and other professionals who handle these products daily, in order to make the new packaging more practical and safe.

To reach a design that is clean and easy to identify, unnecessary information was removed from the front and side faces of the boxes, leaving only required and regulated elements. On the back, only technical data and information regarding the company were kept. To facilitate the identification of each product and its location within each step of the diagnostic imaging process, different colors were defined for packagings and their respective stickers, leads and storage flags. In support of that, a set of iconography was also created, where each element represents the main function of the product. The result is the ease of day-to-day handling of the product by the professionals and the patient safety.

Packaging is defined as the collection of different components which surround the pharmaceutical product from the time of production until its use. Pharma Packaging products is a broad, encompassing, and multi-faceted task. Packaging is responsible for providing life-saving drugs, medical devices, medical treatments, and new products like medical nutritional in every imaginable dosage form to deliver every type of supplement, poultice, liquid, solid, powder, suspension, or drop to people the world over.

Bilcare suggests ways to beat hidden costs in Pharma Packaging

Identifying and eliminating hidden costs in Pharma packaging is a challenging and time consuming process. Everyone strives to eliminate these hidden costs and find ways to reduce the time spent on a project.  A few measures can cut down the hidden costs involved and help in saving time. Bilcare, a widely known and trusted name in the pharmaceutical industry, points out the ways to save on Pharma packaging and beat the hidden costs.

It might be an understatement to say how incredibly valuable time is in today's business environment, but it needs to be emphasized until we all are more cognizant of our opportunity costs. Since we could always use more time and opportunity to do what gets the best return, we're confident we can save you both time and energy in these key areas and get the product packaging you need for optimal function and shelf appeal. Here are the measures Bilcare suggests to save on pharma packaging. 

Bilcare Packaging

The first measure includes sourcing the best packaging components or total solution from the huge global network. Global networks don't just spring up overnight, but the pharmaceutical packaging specialists have an extensive history of growing the network for the long-term. Bilcare states that our customers don't have to start from scratch and each of our experiences lead to your gains.Sharing the industry knowledge to help customers stay on top of changes in regulations and more is a great way to save time and effort. Whether it is a required change for child resistant packaging for products containing imidazolines or a rather obscure best practice talked about deep inside the pharmaceutical packaging industry, Bilcare focuses on leveraging the depth of knowledge for the customers. The company further suggests finding the best freight option for the customers to help them. It can be made as simple as a few questions for the customers and then run with it to get the product from where it starts to where it needs to arrive at the time it's needed. Bilcare looks forward to save the time and deliver superior customer service, and this is a prime example of the areas the company sets benchmarks and delivers the best to society.

How to Beat Hidden Costs in Pharma Packaging?

Especially for anyone balancing their priorities, juggling multiple projects, and taking on increased responsibility, it can be a real challenge to identify and eliminate hidden costs like time spent on pharmaceutical packaging. Ironically, you often have to spend time just to find ways to cut time spent on a project. However, it gets easier when you know who to turn to and know how to examine the following key areas to achieve savings you can measure.

How to Save on pharma packaging?
It might be an understatement to say how incredibly valuable time is in today’s business environment, but it needs to be emphasized until we all are more cognizant of opportunity costs. Since we could always use more time and opportunity to do what gets the best return, we can save both time and energy in these five key areas and get the product packaging you need for optimal function and shelf appeal.

Here are the savings we’re seeking out for customers:
1. Sourcing the best packaging components or total solution from huge global network. Global networks like ours don’t just spring up overnight, but pharmaceutical packaging specialists have an extensive history of growing network for the long-term. Our customers don’t have to start from scratch and each of our experiences lead to your gains.

2. Sharing industry knowledge to help customers stay on top of changes in regulations and more. Whether it is a required change for child resistant packaging for products containing imidazolines or a rather obscure best practice talked about deep inside the pharma packaging industry.

3. Finding the best freight option.  Make this as simple as a few questions for you and then run with it to get your product from where it starts to where it needs to arrive at the time it’s needed. Always looking to save you time and deliver superior customer service, and this is a prime example of one area we do everything to deliver on that.

4. Holding network to a high set of standards to deliver the highest quality products. Global advantage is something we take much pride in, so we utilize every opportunity to bring a world-class approach.

5. Utilizing knowledge that comes from year after years of experience as a leader in the packaging industry. At Bilcare Packaging, work is a tradition handed down through the family and to extended family of employees building long-term relationships and packaging authority. Teams of experts and specialists have always worked for the long-term and lead so customers can have every advantage possible.

The result of good-quality pharma packaging

The future of sustainable, high-quality pharma packaging depends on the development and follow-through of a strict assessment plan at all levels of an organization’s supply chain. This may mean manufacturers rely more on their packaging suppliers to promote sustainability. By using biodegradable resources, like paperboard, and by using those that support sustainability at all stages of the package lifecycle, organizations can satisfy the demands of safety-compliant and sustainable packaging.

Although challenges still exist in the pharma packaging production, innovation will continue to provide solutions for more efficient packaging and a cleaner environment. Research planning and development departments and engineers will all play a key role in the future of pharma packaging. Pharma companies will benefit from the time spent transitioning to a more sustainable model, especially as they see growing consumer satisfaction.

While the process is challenging, this shift to sustainability will positively impact the pharma industry, and any others who produce packaging, the consumer, and most importantly, the environment.

The assessment and controls depend on what your drug is—so there is not a catchall solution.

“Some drugs can be absorbed, some can be inhaled, some can be ingested, and some therapeutics can be all three. So you have to build in safety systems for all three methods of transportation into the worker’s body.” Rather than develop these safety systems for every drug individually, the guidelines suggest building a banding system that is used for all drugs.

The point of building a banding system is to categorize the risk levels of drug properties. Through a team represented by toxicology, health and safety, engineering, quality, validation, and operations, those categories are delineated into bands based on the control processes (including process, operational, engineering, and procedural controls) that the packager can implement. Examples of controls include containment systems, housekeeping, room ventilation, material transfers, and airflow controls. Then during the individual drug assessment, a drug is assigned to a band based on the comparison of the drug properties vs the band properties.

Pharma packaging and Suppy Chain

The global pharmaceutical sector is embarking on a transformation journey in which the supply chain will play an increasing strategic role. There will be a need for greater agility and improved speed to market, while ensuring compliance with myriad regulatory requirements. This forms a challenging landscape for the global pharma packaging industry. Consider what happens when supply chains break down: Drugs are delayed to market, customers experience poor service, security and compliance risks heighten, and a host of missed opportunities occur.

So when you are selecting a contract packager to handle your supply chain, there are several factors to consider. One is length of service.Other factors to consider include:

• Compliance with the FDA, DEA, as well as the MHRA
• Employment of rigorous QA processes and cGMP quality systems
• GDUFA Compliance
• Serialization capabilities and experience
• Capabilities which include Rest of World (RoW) packaging, Brite stock labeling and F=1 compliant packaging
• Pharma packaging design services for turn-key production
• Pharmaceuticals (Rx, OTC, Generic & Private Label), Nutritional & Supplements, Beauty & Personal Care, Medical Devices, Veterinary Healthcare
• Small to large batches
• Cold chain storage & retain storage

It is to be clear you can rely on our increased capacity, our commitment to responsive delivery expectations, and our agility in meeting the custom needs of your business. It is currently met every standard and It will continue to add capacity where needed to meet the unique specifications of our pharmaceutical customers

Pharma Packaging Market

Packaging is one of the largest industry sectors in the world, worth several billions. Pharmaceutical packaging represents a meager percentage of this colossal market. The global healthcare industry has seen a shift in paradigm and is now skewed toward effective and meaningful packaging. Packaging was considered as an afterthought which was required merely in the final stages of manufacturing for many pharmaceutical companies about a decade ago. But of late, pharma packaging has quickly become an essential part of the drug delivery system as well as a core element of the marketing mix, through which manufacturers can differentiate their products from those of their competitors. As drug manufacturers approach the 21st century, they face a number of challenges that packaging can help them meet. The demand for pharmaceutical packaging is increasing and will continue to increase as companies rely more on packaging and labeling as media to protect and promote their products, increase patient compliance, and meet new regulations.

The global pharma packaging market is projected to witness a CAGR of approximately 8% (2015-20) in the coming five years. The market is expected to be fueled by off-patenting of drugs and expanding the generics market. The global pharmaceutical industry is presently undergoing swift expansion, a lot of technology innovations and rapid advancements in manufacturing processes and integrations. These factors are auguring growth of the pharmaceutical packaging industry globally. Due to increasing generic and contract manufacturing activities in Asian countries especially India and China, the emerging geographies are expected to register maximum growth.

The global pharmaceutical packaging market is expected to witness significant push due to incessantly rising demand of biologics. Advances in biotechnology often lead to the introduction of new therapies that must be injected; the pharmaceutical packaging market is expected to witness fastest growth from pre-fillable syringes and parenteral vials. Availability of raw materials and price volatility coupled with changing health regulations are the major deterrents which is curbing the growth of this market.

The fastest growth in the pharma packaging market is expected to come from pre-fillable syringes and parenteral vials, which will continue to expand as advances in biotechnology lead to the introduction of new therapies that must be injected. The increasing demand for biologics will strengthen demand for innovative product packaging solutions in the global pharma packaging market. All these factors, along with the growing pharma industry, will continue to drive demand for packaging. However, the packaging industry will have to overcome challenges, such as the availability and price volatility of raw materials and changing health regulations, in order to meet increasing demand from the growing pharma industry.

Pharma Packaging Innovations

Bilcare Research is a leading full-service provider in the field of pharma packaging. As a global supplier with single-source capabilities, we offer a comprehensive range of pharmaceutical packaging solutions, from product-specific research to brand-building materials and design.

It is our aim to innovate and develop pioneering packaging solutions to meet the complex needs of the pharmaceutical industry. With our integrated services, we enable clients to focus on their core business, i.e. development of new drug molecules, formulation development, manufacturing and marketing while we partner with them in the area of drug stabilization and protection. We help customers capitalize on upcoming trends, through products that maximize the commercial potential and efficacy of drugs.

Our strength lies in the powerful synergy of our research capabilities, state-of-the-art design and manufacturing facilities and commitment to create sustainable competitive advantages for our customers. Our competency in developing specialty pharma packaging material and designs helps customers in addressing compliance and counterfeit concerns.

Today, Bilcare Research is a market-leading supplier of specialty primary packaging for pharmaceutical products. We have been honoured by the Organization of Pharmaceutical Producers of India (OPPI) Award for achieving remarkable success in providing novel packaging alternatives and services to the pharmaceutical sector for two consecutive years.