European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Nursing Homes Pharmaceutical Manufacturing Department of Veterans Affairs Dosage 97

European Pharmaceutical Review

OCTOBER 1, 2024

A paper has demonstrated a novel application of optimising processes to implement inverse design in pharmaceutical manufacturing. Machine learning techniques were assessed for use as a surrogate model to optimise a three-unit wet-granulation based flowsheet model for the manufacture of solid dosage forms. Dan et al.

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Dosage Pharmaceutical Manufacturing 64

FDA Law Blog: Biosimilars

APRIL 16, 2024

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

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Dosage Drug Pricing Pharmaceutical Manufacturing 59

European Pharmaceutical Review

FEBRUARY 9, 2023

Processes in pharmaceutical manufacturing such as processing, milling, grinding, and mixing, are associated with the generation of dust. The researchers highlighted that the risks of hazard exposure include danger to the health of operators and cross-contaminations during manufacturing.

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Dosage Pharmaceutical Manufacturing Compounding 105

Express Pharma

NOVEMBER 26, 2024

” Dr Veeramani, Chairman, Pharmexcil, said “ The Indian pharmaceutical industry stands as a global leader, exporting to over 200 countries and providing comprehensive solutions across APIs, finished dosages, clinical research, and pharmacovigilance.

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Packaging Biosimilars Pharmaceutical Manufacturing Dosage 105

pharmaphorum

JULY 28, 2022

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. The post How can the pharma industry navigate issues in the global supply chain to minimise drug shortages?

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Diabetes Dosage Pharmaceutical Manufacturing Documentation 111

Express Pharma

APRIL 13, 2023

They are less toxic and have a higher degree of solubility, thus making them better candidates for liposomal-based drug delivery systems, especially for parenteral administration and inhalation dosage forms. Quality assurance and costs remain a major challenge.

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Vaccines Dosage Pharmaceutical Manufacturing Labelling 97

Pharmaceutical Technology

AUGUST 3, 2022

During this stage, a team of lab technicians must identify the best way to manufacture the active pharmaceutical ingredient (API) into a suitable dosage form for pilot production. If clinical trials prove successful, that same process should then be scaled to commercial manufacturing.

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Dosage Pharmaceutical Manufacturing Drug Development 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

Commercial dose companies form a critical component of the pharmaceutical manufacturing industry’s value chain. The dose form manufacturing follows API manufacturing to produce the final dosage form (FDF such as tablets and injectables.

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Dosage Pharmaceutical Manufacturing Documentation Pharmaceutical Companies 40

Pharmaceutical Technology

MAY 11, 2008

TABLET FORMATS One of the problems with track and trace for pharmaceuticals across the world is the way drugs are dealt with on an item level in Europe and the US. In the US solid dosage forms are distributed as containers of tablets and these can only be coded on the container and not on a per-item basis.

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Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 40

Viseven

JANUARY 13, 2023

Defining Drugs Dosage Even when all stages of the clinical trial are over, there are still many things pharmacists and doctors may learn after patients will get access to the new treatment. Such insights may consider the efficiency, safety, quality, or dosage of the drug.

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Pharmaceutical Companies Pharmaceutical Companies Dosage Drug Pricing 40

Viseven

SEPTEMBER 14, 2023

Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. To give you an example, a pharmaceutical manufacturer, Moderna , relies on Looker, an AI-powered data analytics solution delivered by Google.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Dosage 52

Quality Matters

MAY 17, 2023

Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.

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Drug Development Dosage Pharmaceutical Manufacturing 52

Quality Matters

SEPTEMBER 15, 2023

PCM not ideal for every drug Continuous manufacturing “may not be fit for every pharmaceutical manufacturing process, but it can bring some advantages in some cases” compared with traditional batch manufacturing, summarized FDA’s Adam Fisher, Ph.D., It is not intended as a comprehensive summary or report.]

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Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies Dosage 52

GMPSOP

SEPTEMBER 27, 2023

The practice of calling a piece of equipment clean just because it looks clean is not acceptable in the pharmaceutical manufacturing process. Why is cleaning validation required? Equipment that is used for processing medicines is one of the top sources of contamination if not cleaned effectively using a validated cleaning procedure.

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Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

GMPSOP

MARCH 8, 2024

Pharmaceutical manufacturers must have written procedures on the steps to take when any result does not meet specifications. To replace the single invalidated result, you should test one additional dosage unit for the content uniformity test or perform a dissolution test using one dosage unit.

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Documentation Dosage Pharmaceutical Manufacturing Packaging 52

GMPSOP

JUNE 9, 2024

Name, source, manufacturing sites, and date of manufacture of drug substance) – Dosage form and strength, including formulation – Composition, type, source, size of container, and closure – Specifications and test methodology (I.e., – Routine recording of environmental parameters (e.g.,

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Method Validation Documentation Health and Personal Care Stores Labelling 52

GMPSOP

JULY 31, 2023

Pharmaceutical manufacturing operations typically maintain equipment varying from simple balances and scales to complex automated process control and monitoring systems. – Disintegration Testers (Critical for assessing the disintegration properties of solid dosage forms). When is equipment qualification necessary?

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Documentation Dosage Labelling Data Entry 52

GMPSOP

OCTOBER 28, 2023

Quality is everyone’s responsibility, and it should pervade every aspect of pharmaceutical manufacture and packaging. Quality should not be tested into products; instead, it must be built in at each step of manufacture. Pharmaceutical manufacturers must integrate the key functions of the quality control process.

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Documentation Method Validation Packaging Data Entry 52

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. What are the types of sampling plans in pharmaceutical industry?

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

GMPSOP

MAY 26, 2023

Such as product name, batch number, expiry period, ingredients, composition, concentrations, dosage information, storage condition, age restriction, etc. Change control management for raw material suppliers and manufacturer Raw materials used in pharmaceutical manufacturing can be active or excipients.

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Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Such as product name, batch number, expiry period, ingredients, composition, concentrations, dosage information, storage condition, age restriction, etc. Change control management for raw material suppliers and manufacturer Raw materials used in pharmaceutical manufacturing can be active or excipients.

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Documentation Packaging Communication Customer Service 52

European Pharmaceutical Review

APRIL 9, 2024

Delpharm has acquired the Meppel pharmaceutical manufacturing facility in the Netherlands from Astellas. The 31,600 square meter facility produces some 40 million finished solid dosage forms each year, including tablets, capsules and pellets. The company employs more than 6,500 people, generating revenues of €1.1

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Pharmaceutical Manufacturing Dosage Drug Development 98

Pharmaceutical Technology

DECEMBER 6, 2022

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. Within the small molecule landscape, several trends are shaping the industry’s future, one of the most notable being the rise of high-potency active pharmaceutical ingredients (HPAPIs).

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Drug Development Dosage Pharmaceutical Manufacturing Communication 52

Pharmaceutical Technology

FEBRUARY 3, 2023

Tablet manufacturing, which is the most common OSD form, takes an API dry powder ingredient and compresses it to form tablets, which can be coated or uncoated. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.

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Dosage Pharmaceutical Manufacturing Packaging Communication 52