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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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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pharmaphorum

MARCH 22, 2021

The International Finance Corporation, the division of the World Bank Group that invests in the private sectors of emerging markets, has provided financing for several emerging market pharmaceutical manufacturers with the goal of boosting developing countries’ access to affordably priced drugs. About the author. Dr Subir K.

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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