The main aim of packaging pharmaceutical products is to ensure that medicines reach the patients for whom medicines are prescribed. The quality assurance system for the manufacture of products should ensure that the manufacture arrangements are made up, supply and then use with the right starting and packaging ingredients. Packaging protects the medicine from every kind of spoilage and altering. A suitable quality assurance system for pharmaceutical products should follow WHO guidelines for excellent manufacturing practice. The packaging should not affect the quality of pharmaceutical medicines itself.
Importance of Selection of the packaging material for pharmaceutical medicines
It can be exciting to bring a new pharmaceutical product into the market. However, it is the most challenging time for manufacturer. In the early stage of the development process, manufacturer often do not keep their focus on packaging. However, manufacturer can get help from experts with the packaging applications experience to expand their production processes and identify possible hazards related to packaging materials.
By selecting consistent components and materials of high quality, distinguishing between a products with a unique delivery system and focusing on competencies, medicinal companies can deliver an effective, safe product.
Tips for selecting packaging material for drug manufacturer
Following are the tips for selecting good and reliable packaging material:
Elimination of leachable and extractable by consistent components:
It is important to look for consistent packaging components from lot to lot. This kind of component will help avoid issues of cost with leachable, specifically when the packaging is being used consistently throughout the life cycle of the product. To determine the possibility of interaction between drugs and early packaging in the process, manufacturer can get help by using the same material from research and production to commercialization. The interactions can affect patient safety, which can lead to different issues like leachable and glass delamination.
Components can be specialized on a lot to lot basis for extractable, including an extractable profile. The closure manufacturing processes and composition are uniforms that can ensure with the help of certification. High-value components such as syringe pistons report several industrial challenges that give the customer the chance of moving quickly into the leachable testing program. It also provides the change control around the component verification. It can be critical and take many years for the completion of the drug development and commercialization cycle.
Costly recalls can avoid by high-quality materials:
In the present and future, the choice of the packaging material can affect the bottom line of manufacturer. The long term advantage is choosing container closure systems made up of novel material like a cyclin olefin polymer. In this way, companies may experience a slightly higher investment. Cyclin olefin polymers have different properties like high quality transparent, break-resistant and more inert than glass, no flakes, unlike glass, which helps reduce contamination of particles within the syringe system. Moreover, they can be stored and transported at low temperatures with less breakage, and it is the most common requirement of biologics.
The use of a plastic system as compared to the existing glass system can help the manufacturer to prevent the following:
- Product production and development internal failures
- Finished drug product failure
- Market recalls linked issues
- Loss of research time and time to market can be the result of defection in the process of development
- Improvement in process and prevention activities for the cost
Maintenance of focus on core business:
Pharmaceutical companies can get help by partnering with a component manufacturer to focus on core business by eliminating the extra time, money, and staff linked with the preparation and sterilization of components. Removing the in-house component preparation process is a cost-effective process of observing and streamlining the filling process and new regulations. In addition, by making a long-lasting partnership with a packaging manufacturer, medicine makers help establish compliance and quality improvement. They have the power to rely on expert advice and counsel during a drug’s life cycle.
For the efficacy of drug therapies and safety, containers and administration devices are important. Therefore, the orientation of pharmaceutical packaging with drug development and production processes will increase the quality and patient safety.
Unique delivery or system of administration differentiation
For the success of a drug product, to pass out through the regulatory approval process easier and to the market swiftly, medicine packaging plays an important role. The product delivery determination should be based on scientific application, but you cannot try a high-risk new packaging material system. Drug manufacturers should look for reliable and low-risk material for packaging that needs to be standardized. Then, the optimized delivery should apply a unique and different delivery system. In several cases, the main goal should be to move from stopper system to auto-injector system. Always choose a material that can use throughout the drug process, such as cyclic olefin polymer that helps reduce time to market.
Because of plastic material, it can be molded into a different variety of sizes and shapes. It enables the manufacturer to provide special delivery without any requirement of retesting material for interaction with the medicine product. We need to focus on the print of medicine packaging boxes, and it can have quite a detail but not all the information about the medicine. Indus Printing Company is also working on pharma medicine box design; it is the famous printing press in Lahore Gulberg.
Risk reduction by an early partnership
Enhancement in regulatory guidance on today good manufacturing practices has an impact on drug manufacturing. In alternation to the FDA regulations for finished pharmaceutical requires more compliance that concerns preparing a composition for sterile products. The requirement for each lot of drug products container constitutes vulnerable to contamination when to undergo microbiological testing before the products are used; validation for all sterilization processes is also required. By making a strong partnership with a packaging manufacturer, any pharmaceutical company can improve its manufacturing methods, creating better and high-quality container closure and drugtransportation systems.
This kind of partnership is beneficial both for the drug and packaging manufacturers. Knowing each other processes and potential troubleshooting drawbacks will allow the manufacturer to improve the product and the medicine packing to meet high-quality standards.