GMPSOP

DECEMBER 10, 2023

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. Accurate labelling of medicines is critical to patient health.

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Packaging Health and Personal Care Stores Labelling Documentation 52

European Pharmaceutical Review

OCTOBER 5, 2022

For most consumers, product packaging represents their first impression of a brand and its sustainability credentials. But how is this push shaping the pharma packaging market and what are the key changes we can expect to see? For many, aesthetic appeal and user experience top the list of priorities when it comes to packaging design.

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FDA Law Blog: Biosimilars

JUNE 26, 2024

Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A 513(g) Request for Information is a means of obtaining FDA’s views about the classification and regulatory requirements for a particular device.

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Pharmaceutical Technology

SEPTEMBER 20, 2022

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.

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Pharma Packaging Solutions

SEPTEMBER 15, 2022

Pharmaceutical packaging companies play a critical role in the pharmaceutical industry. Thus, choosing a packaging company to partner with is a very important decision. When evaluating a pharmaceutical packaging company, your first order of business should be determining whether it has the capabilities to meet your specific needs.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

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. Pharmaceutical packaging formats and materials. Pharmaceutical packaging formats and materials.

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Pharmaceutical Technology

JUNE 14, 2023

Navigating the complexities of pharma and biotech packaging services can be difficult. With the growing number of complex therapies that require specialized packaging and handling requirements, selecting the right contract packaging organization (CPO) involves evaluating what services and additional benefits they can bring to your business.

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pharmaphorum

JANUARY 28, 2021

For PRISYM ID client RxSource , a Global Clinical Trial Supplies Specialist, it means being ready to partner with sponsor companies to get everything set up for a clinical trial within a week, including packaging and labeling. This was an incredibly fast turnaround for what could easily have been a long and arduous onboarding process.

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Pharma Packaging Solutions

FEBRUARY 27, 2020

If you will be at DCAT in March, we would like to meet with you – sustainable packaging will be on the table. Our heat-sealed blister cards and folding cartons are, by their very nature, also a renewable packaging choice. And let us know what further information we can provide for a project you need.

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Express Pharma

MAY 6, 2024

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. According to its statement, PHARMAP 2024 brought together over 330 professionals from across the industry’s value chain.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling.

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Pharma in Brief

MARCH 18, 2021

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. A drug’s “label” can include its inner or outer labels, a package insert, or its product monograph ( PM ). Guidelines for electronic labelling.

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GMPSOP

AUGUST 11, 2024

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.

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European Pharmaceutical Review

NOVEMBER 24, 2022

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

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GMPSOP

MARCH 30, 2024

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.

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GMPSOP

MARCH 3, 2024

Cross contamination in the pharmaceutical industry can be described as an accidental inclusion of product of another batch or unknown foreign material into a finished batch, which was not intended or not mentioned on the label. What are the examples of cross contamination in pharmaceutical industry?

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Health and Personal Care Stores Packaging Labelling Documentation 52

Pharma Packaging Solutions

JUNE 30, 2023

As biopharma technology progresses, becoming both more prevalent and available, the need for high-quality biopharma packaging increases. We offer a variety of packaging services, including vial and ampule labeling, pharmaceutical kit assembly, and more. appeared first on Pharma Packaging Solutions.

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European Pharmaceutical Review

JANUARY 25, 2024

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. However, according to the FDA, this is “less of a concern” for products, such as biological products, that are packaged in glass containers.

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Pharma Marketing Network

AUGUST 9, 2023

Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Ensure that all marketing materials, including advertisements, websites, and social media content, provide clear and accurate information about your products. Keep thorough records of approvals for future reference.

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Express Pharma

AUGUST 10, 2023

Real-time visibility, down to 1-2 meters within the network enabled by a mesh sensor that is affixed to the package alongside the address label. UPS Premier Gold is also available in India offering the following benefits: Visibility is integrated within all UPS tracking systems.

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FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. In addition, the final rule requires the submission of product information to the Global Unique Device Identification Data (GUDID).

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Express Pharma

SEPTEMBER 6, 2024

Additionally, these ingredients are produced in US FDA-approved, GMP-certified facilities and are labelled Generally Recognised As Safe (GRAS) by the FDA. One strategy is that supplement manufacturers should display the logos of branded ingredient suppliers along with QR codes on their product packaging.

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Express Pharma

MAY 24, 2024

Adding to that, the companies which are specialised in nutraceutical use a high-quality control as the main aspect of manufacturing, packaging, and distribution. This requires adherence to Good Manufacturing Practices during production, processing, packaging, and storage for manufacturers to ensure consistent quality standards.

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Pharma Marketing Network

AUGUST 9, 2023

Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Ensure that all marketing materials, including advertisements, websites, and social media content, provide clear and accurate information about your products. Keep thorough records of approvals for future reference.

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European Pharmaceutical Review

JUNE 4, 2024

Solutions include washers, depyrogenating tunnels, liquid and powder filling and closing machines for vials, ampoules and Ready-To-Use (RTU), freeze dryers and relevant automatic loaders/unloaders, isolation technologies, labellers for vials and cartons and ancillary equipment.

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Pharmaceutical Business Review

OCTOBER 14, 2024

The committee’s decision was informed by data from the TAZPOWER Part II baseline-controlled extension trial, the SPIBA-001 Phase III natural history control study, and additional biomarker and preclinical outcomes.

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FADIC

JULY 14, 2024

OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. Here are some resources that can provide you with the best information on OTC drugs. Link National Institutes of Health (NIH) The NIH is a part of the U.S.

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Pharma Packaging Solutions

SEPTEMBER 26, 2019

We have plenty of new things to talk about including sustainable packaging – this seems to be a hot topic and we are your sustainability packaging partner. Of course, if you need blister packaging or bottling or vial labeling, we can discuss that too. appeared first on Pharma Packaging Solutions.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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Pharmaceutical Technology

SEPTEMBER 5, 2022

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Quality in terms of number of defective items, packaging and labelling, quality management system certification, research, development, and innovation.

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GMPSOP

APRIL 3, 2024

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.

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Express Pharma

SEPTEMBER 8, 2023

What use does the label serve, and who is responsible for making sure the QR code is still working when it changes commercial hands? What assurance is there that counterfeiters who can easily mimic a brand’s packaging, name, and logo won’t also be able to mimic its QR codes? It is useless if the QR codes are broken.

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Packaging Labelling 52

Express Pharma

APRIL 6, 2023

This can include everything from product testing and labelling to marketing and advertising requirements. As a result, nutraceutical startups need to stay informed about the latest regulatory changes and requirements in the states where they do business. Failure to do so can lead to legal and financial consequences.

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European Pharmaceutical Review

JANUARY 23, 2023

Through EMA’s engagement with its stakeholders, the Medicines Shortages Steering Group has received up-to-date information from community pharmacists on the situation in pharmacies across the EU. Based on current information from companies and stakeholders, it is expected that the situation will improve in the coming months.

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Express Pharma

MAY 9, 2023

Whereas proper disposal of unused medications, as well as initiatives to reduce packaging waste, chemical waste, and improve recycling programmes, will aid in pro-actively addressing this challenge. This may involve the use of eco-friendly raw materials, green manufacturing processes, and eco-friendly packaging.

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Eye on FDA

AUGUST 22, 2023

The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. First, while presenting the indication in the posting, there was no risk information included in the communication.

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GMPSOP

NOVEMBER 15, 2024

Stability testing ensures that the manufactured products remain safe, pure, and effective throughout their shelf life if they are kept in specified packaging and under environmental conditions. They are necessary for the API testing method and will also have to be conducted for the formulated and packaged product.

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