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Gerresheimer, a systems and solutions provider for the pharmaceutical and biotech industry, has introduced a web-based product database designed to streamline the selection and registration of primary plastic packaging for medicinal products. Production departments assess filling-line compatibility and labelling formats.
The worldwide pharmaceutical container packaging market is expected to rise in revenue from $104.12 billion by 2033, according to a study published by Towards Packaging. Specifically, the “high quality of biodegradable and recyclable packaging materials” are driving the market. West Pharmaceutical Services Inc.
This allows for streamlined regulatory processes and a reduced administration load for both pharmaceuticalcompanies and health authorities, according to the paper. The associations explained this is enabled through multi-country packs which are simplified by the language exemption and harmonised labelling requirements.
The generic drug approval process is a complex, multi-step journey that involves several stakeholders, including pharmaceuticalcompanies, regulatory agencies, and healthcare professionals. The journey to approval is often shrouded in mystery, but it's a crucial process that affects millions of people worldwide.
The impact of packaging is felt only when it does not do its job and therefore pharmaceuticalcompanies have traditionally invested quite a bit on product packs, also using them as part of their branding strategy. sq mm of material – there is more than 20 per cent reduction of packaging material. per cent CAGR.
Subscribe Control in Production Processes Pharmaceuticalcompanies must adhere to Good Manufacturing Practice (GMP) to effectively control contamination of products from microorganisms. – Be alert to damaged packages. Therefore, its microbial “cleanliness” is critical within pharmaceuticalcompanies.
Miranda McLaren June 30, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook When Donald Trump was elected the 47 th president of the United States of America, the outlook for pharmaceuticals was unclear, with 55% of North American industry professionals expecting negative repercussions when surveyed by GlobalData later that month.
Image credit: PeopleImages.com – Yuri A via Shutterstock With tighter budgets, regulatory challenges, and uncertainty from tariffs, pharmaceuticalcompanies are turning to third-party logistics (3PL) suppliers to deliver efficiencies. How will RFK Jr’s American dream for vaccines play out?
Europe’s pharmaceuticalpackaging and labelling market is projected to reach $35.78 billion in 2022, the pharmaceuticalpackaging and labelling market in Europe is expected to expand at a compound annual growth rate (CAGR) of 4.78 billion in 2028, according to a report by Arizton. Having been valued at $27.04
23443940) among several other drugs from various pharmaceuticalcompanies as allegedly being NSQ. The conclusion was based on observed differences in physical appearance, colour, and labelling text between the CDSCO samples and the actual batches. 23444296) and one batch of Clavam 625 tablets (Batch No.
Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers.
Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Pharmaceuticalpackaging formats and materials. Pharmaceuticalpackaging formats and materials.
This concerns the quantity of the medicinal product in the packaging, ie, the increase or decrease in the number of units of the product in the outer packaging according to local demands and its labelling, including the leaflet, which should be in the language of the country into which the product is imported.
Full-Service Capabilities A full-service CDMO should provide comprehensive, end-to-end capabilities that support the entire pharmaceutical development and manufacturing process. This includes drug substance and drug product development, clinical trial logistics, product labeling, supply chain management, commercial packaging, and more.
Proper line segregation involves physically separating different lots of starting materials, labeling components, and printing matters, many of which look similar. Different products should not be packaged in proximity unless physical segregation exists. Please look at the labeling operation in the picture below.
Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. In this blog post, we will explore best practices for pharmaceuticalcompanies to navigate the complex landscape of regulatory challenges in marketing.
Documentation : Keeping detailed records of orders, specifications, manufacturing processes, packaging, and labeling to ensure traceability and compliance. Packaging and labeling operations for investigational products are often complex and must meet specific requirements to ensure the integrity of clinical trials.
Wholesalers can be either full-line wholesalers, who purchase the complete product line of a company, or specialised companies, which purchase speciality drugs to sell to clinics and hospitals. The post Leading pharmaceutical wholesalers appeared first on Pharmaceutical Technology.
Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. In this blog post, we will explore best practices for pharmaceuticalcompanies to navigate the complex landscape of regulatory challenges in marketing.
Pharmaceuticalcompanies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. Europe is favouring 2D data matrix codes to encode information while the US is tending more towards RFID.
She has worked with regulatory agencies and pharmaceuticalcompanies for over 10 years. Sophie Jouaville , PhD, is an associate principal at IQVIA, where she works on the design and oversight of non-interventional real-world evidence (RWE) safety and health economics and outcomes research (HEOR) studies.
The Guidance applies to all member companies of EFPIA and IFPMA, but also acts as useful guidance for all pharmaceuticalcompanies as to how the authorities will interpret the legislative provisions to social media channels. The Guidance applies to both product-related and therapeutic-area-related activities.
Pharmaceuticalcompanies are looking to paediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. Cambrex, for example, has a track record of success in partnering with several pharmaceuticalcompanies in the development and commercialisation of clinically suitable PDFs. Faster to market.
They should place all discarded cardboard, paper, and corrugation from the Packaging Dept. Quality assurance inspectors destroy all unused labels and inserts from the Packaging Lines. Clearly label and store materials in designated areas to prevent cross-contamination and mix-ups. in the compactor.
All waste generated during the cleanup should be disposed of properly in labeled bags, and the equipment used must be cleaned and stored appropriately. Examples include oil leaks from equipment in a packaging line or small solvent spills in the printing and labeling machine. Major spills These involve serious chemical releases.
Adulterated Pharmaceuticals: 396 warnings iii. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. CGMP Deviation: 39 warnings ii. Adulterated API: 39 warnings iv. Adulterated Food & Supplements: 78 warnings v.
Packaging material specifications In the pharmaceutical industry, the requirements for pre-printed packaging materials must be well-defined and documented to ensure that you get the items you specified or ordered and that there are no mix-ups. A standard name and a unique item code define packaging materials.
GMP/GLP and PPE training are applied to all employees, contractors and casual staff working in a GMP environment, including manufacturing, packaging, labelling, distribution, QA, QC, development, validation, engineering, IT staff and anyone whose activities could affect product quality. </p>
Pharmaceuticalcompanies are accountable for properly warehousing, shipping their products, and guaranteeing their stability until expiry. Process validation master plan The process validation master plan accounts for all manufacturing and packaging processes directly employed in the manufacturing and packaging registered products.
Particularly the printed packaging materials where product information is presented. Printed packaging materials typically include product names, active ingredients, concentration, batch numbers, expiry dates, registration numbers, barcodes, etc. Commonly used packaging materials are cartons, inserts, leaflets, printed foil, etc.
A pharmaceutical warehouse is responsible for receiving, storing, and releasing incoming goods (including labeling and packaging) and distributing finished products. These regulations recognize that product quality can be significantly impacted if manufacturing and packaging have taken place.
Each tablet has the label claim of 100mg (w/w). Subscribe Prev PREVIOUS POST Kazi Hasan Kazi is a seasoned pharmaceutical industry professional with over 20 years of experience specializing in production operations, quality management, and process validation. Access to exclusive content for an affordable fee. </p>
The event brought together over 330 professionals from across the industry’s value chain Pharmaceutical Manufacturing and Packaging Congress (PHARMAP 2024) was held in Amsterdam, Netherlands on April 22-23, 2024. Topics of sessions delved into the future of pharmaceutical manufacturing, focusing on Industry 4.0
You should not be unfamiliar with it if you know how pharmaceutical facilities operate. Cross contamination in pharmaceutical industry is a serious issue which can affect the quality and safety of drugs. What are the examples of cross contamination in pharmaceutical industry? Cross contamination data that can make you nervous!
Stability testing overview for Pharmaceutical products Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST Pharmaceutical products must maintain quality, safety, purity and efficacy throughout their specified shelf-life conditions up to their nominated expiration date.
Crossing the approval hurdle for a new drug is a big milestone for pharmaceuticalcompanies. Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them. Regulatory decisions come in.
Partners Group, another existing equity holder, is making a minority investment, the company said. PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially. That funding was supported by a “significant reinvestment” from current backer Mubadala Investment Co.
Follow package instructions. Follow package directions for each supplement. Precautions Do not take more than the recommended dose on the label. If you’re experiencing these symptoms, reduce your dosage to ⅛ teaspoon daily, increasing usage slowly, as tolerated, to get to the recommended label usage.
Other Affiliations: Angela is an active Board of Director member of the Pfizer Foundation (a charitable organization addressing global health challenges), European Federation of Pharmaceutical Industries and Associations (EFPIA), and UPS (the global leader in package delivery and supply chain logistics).
The FDA sets stringent requirements for operational qualification for critical equipment and systems to ensure the safety and efficacy of pharmaceutical products. These requirements mandate that pharmaceuticalcompanies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.
Pharmaceuticalcompanies regularly outsource different steps of drug manufacturing processes like parenteral manufacturing and packaging, solid dose, and small molecule or biologic active pharmaceutical ingredient (API) production, among others. This was the first non-stimulant drug approved for ADHD in over a decade.
Within pharma and healthcare, where greater representation has been proven to lead to better health outcomes for all patients and the pharmaceuticalcompanies developing medicines, change is also happening. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines. About the authors.
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