European Pharmaceutical Review

JULY 3, 2023

Therefore CDER stressed the need to maintain labelled storage conditions and monitor those conditions throughout the drug supply chain. Reflecting on five years of quality control for nitrosamine impurities Warning Letters In FY2022, the FDA issued 72 CGMP-related warning letters to pharmaceutical manufacturing sites.

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Pharmaceutical Technology

JUNE 23, 2025

Bayer has responded by eying a label extension that would allow injections of its high-dose version in intervals of up to six months. Like Eylea, Vabysmo is approved for a range of retinal diseases but has higher uptake due to the longer intervals between injections, giving it market advantage. Sign up for our daily news round-up!

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Biosimilars Pharmaceutical Manufacturing Communication Hospitals 52

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. The post Leading pharmaceutical wholesalers appeared first on Pharmaceutical Technology.

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pharmaphorum

MAY 25, 2022

But the new Joint Guidance on Virtual and Hybrid International Medical Congresses, from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) is here to plug that gap.

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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. Before filling and labeling, you should thoroughly examine the filling line using a standard operating procedure. Please look at the labeling operation in the picture below.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

The pharmaceutical industry requires specialised and cost-effective commercial packaging solutions to improve efficiency and preserve the integrity of products through the entire supply chain, from primary packaging and labelling to shipping, delivery, storage and distribution to end users.

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GMPSOP

FEBRUARY 25, 2023

Table of Contents Importance of sampling in pharmaceutical industry Pharmaceutical sampling procedures are carried out during and at each major processing step during the manufacturing to ensure the highest quality is attained. Pharmaceutical sampling procedures ensure all of the above. as their visual aids.

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

pharmaphorum

DECEMBER 16, 2022

Tendayi Achium, labelled the response by the global community as a form of “vaccine apartheid,” a suggestion echoed by the organisation’s director general. The UN Special Rapporteur on contemporary forms of racism, E. The discussions over the treaty are set to continue for some time.

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pharmaphorum

APRIL 15, 2021

Astellas’ regulatory affairs function plays a key role in helping to define the final target indication of the therapy, or broadening the target for the profile, or target product label. “In We work together to define an optimal label which will help maximize the value of our therapy for patients.”. Looking to the future.

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Pharmaceutical Technology

MAY 11, 2008

” LEVEL TRACKING Pharmaceutical manufacturing company Seidenader Vision has also developed a system – the SATrack and Trace. ” THE DOMINO EFFECT There are many examples of how these technologies have helped make pharmaceutical manufacturing safer for the consumer. .

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pharmaphorum

OCTOBER 27, 2022

She also advises companies on the boundaries of the ABPI and EFPIA codes of practice, as well as UK and EU legislation, regarding the promotion of medicinal products, including use of social media, packaging and labelling, presence at conferences, use of consultants, and marketing materials.

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Quality Matters

AUGUST 3, 2023

While focuses on evaluating and establishing supplier reliability for pharmaceutical manufacturing companies and compounding pharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients.

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GMPSOP

AUGUST 23, 2022

Table of Contents Quality risk management principles are already effectively utilized in many areas of pharmaceuticals manufacturing business. Is this system used in the creation or verification of product labelling (inserts, outserts, cartons or packaging)?

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GMPSOP

JUNE 9, 2024

Proper labeling and traceability are essential when it comes to reagents. All reagents, whether bought from suppliers or made in the lab, must have legible labels with their name, lot or batch number, and vendor information. Labels that identify divisions in reagents should enable us to locate the original source.

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Method Validation Documentation Health and Personal Care Stores Labelling 52

Putting Patients First Blog

APRIL 7, 2025

Furthermore, FDA guidance should include requirements for clear labeling and disclosure of any remaining performance limitations or biases, ensuring clinicians and patients are aware of potential constraints in real-world contexts.

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GMPSOP

JUNE 28, 2024

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. Everyone in the pharmaceutical manufacturing facility is responsible for reporting a deviation as soon as one is identified.

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GMPSOP

OCTOBER 28, 2023

Typical flow of samples in a quality control laboratory The quality control laboratory receives samples that are collected randomly at the beginning, middle, and end of manufacturing processes. Quality is everyone’s responsibility, and it should pervade every aspect of pharmaceutical manufacture and packaging.

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GMPSOP

MARCH 20, 2024

SOP for instrument calibration: Instrument calibration is important for pharmaceutical manufacturing standards. After each successful calibration, label the instrument with its calibration status, indicating the date of calibration, the next due date, and the initials of the personnel who conducted the calibration.

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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. Materials and products may not need physical status labels or be stored in separate areas if computers are used. Common mistakes made during the repacking process?

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GMPSOP

MARCH 8, 2024

Each tablet has the label claim of 100mg (w/w). Pharmaceutical manufacturers must have written procedures on the steps to take when any result does not meet specifications. Access to exclusive content for an affordable fee. It is improbable that all 20 results will be 100 mg exactly.

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GMPSOP

MARCH 17, 2023

– Status control: implementing status labels to clearly identify workflow status such as issues, returns, rejects and reworks of components to prevent mix ups. . – Warehouse: resolving any discrepancies in inventory records, such as a discrepancy between the physical count and the recorded count.

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GMPSOP

MAY 31, 2024

Validation master plan flowchart Key elements to consider during validation activities We have told you the common validation examples typically undertaken by the pharmaceutical manufacturing facility. Also, we have demonstrated the five stages of the validation lifecycle.

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Pharma Marketing Network

JUNE 11, 2020

We may do some things like you were talking about where we have advertorials, and it’s clearly labeled as an advertorial. If you’re a pharmaceutical company or if you’re an agency or even a consultant. We want to be a resource for them.

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GMPSOP

MAY 26, 2023

– Assessment of packaging and labeling components. Change control management for raw material suppliers and manufacturer Raw materials used in pharmaceutical manufacturing can be active or excipients. . – Implementation information (i.e., date, dependencies, etc.). – Impact on product supply.

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GMPSOP

MAY 26, 2023

– Assessment of packaging and labeling components. Change control management for raw material suppliers and manufacturer Raw materials used in pharmaceutical manufacturing can be active or excipients. . – Implementation information (i.e., date, dependencies, etc.). – Impact on product supply.

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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. Among the attendees, contract manufacturing organisations, service providers and experts were present.

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GMPSOP

DECEMBER 10, 2023

Packaging and labelling mix-ups can potentially result in serious health consequences. Accurate labelling of medicines is critical to patient health. Accurate labelling of medicines is critical to patient health. Particularly the printed packaging materials where product information is presented.

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GMPSOP

JUNE 15, 2025

Effective Control of Microorganisms in Pharmaceutical Manufacturing Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST The control of microorganisms in pharmaceutical production ensures that they stay at acceptable levels. Hence, spores require complex treatment to remove them.

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Pharmaceutical Manufacturing Health and Personal Care Stores Documentation Compounding 52

Express Pharma

APRIL 13, 2023

In a world where ‘natural’ and ‘organic’ have become synonymous with sustainability, labelling a product ‘synthetic’ seems antithetical. There currently exist bottlenecks in the clinical translation of synthetic lipid-based drug delivery systems owing to pharmaceutical manufacturing, government regulations, and IP.

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Pharmacy Times

JUNE 23, 2025

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies.

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GMPSOP

JULY 14, 2023

In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. They should never be topped up, used, or stored without labels and expiry dates. The disinfectant dilution is passed or failed according to the extent of growth shown by the challenge bacteria.

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GMPSOP

JULY 31, 2023

Pharmaceutical manufacturing operations typically maintain equipment varying from simple balances and scales to complex automated process control and monitoring systems. 90% to 110% of the label claim). When is equipment qualification necessary? 5% of the average force).

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Pharmaceutical Commerce

JUNE 17, 2025

This includes requirements for drug data storage and the maintenance of interoperable systems for sharing data, along with requirements for the data that must be stored on treatment labels. Together, these requirements create a foundation of RWD that stakeholders can leverage to improve supply chain operations and safety.

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Quality Matters

OCTOBER 13, 2021

There are also related standards that address a wide range of topics such as packaging, storage and distribution of medicines, the preparation of compounded medicines and prescription labeling. In a 2019 report on drug shortages, the FDA found that 62% of drug shortages occur because of quality issues in manufacturing.

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GMPSOP

MARCH 6, 2025

Rework procedure in pharmaceutical manufacturing Step-by-step guide Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST A rework procedure is a structured way of correcting quality defects identified in a batch or number of batches of pharmaceutical products.

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Express Pharma

JANUARY 27, 2025

Proper storage, labelling, and FEFO rotation of incoming materials were highlighted as essential practices. This session promises to dive into essential practices that can transform pharmaceutical manufacturing processes. The next session in the PULSE Series, Investigations and CAPA, is scheduled for February 02, 2025.

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BioPharma Dive

JUNE 5, 2025

Other tasks performed by Elsa included “summarizing adverse events to support safety profile assessments, conducting expedited label comparisons and generating code to facilitate the development of databases for nonclinical applications.” “One scientific reviewer told me what took him two to three days now takes six minutes.”

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