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.,

Pharmaceutical Manufacturing

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).

Drug Development

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.,

Method Validation

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.

Documentation

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.

Documentation

European Pharmaceutical Review

OCTOBER 12, 2023

September 2023 saw a wave of new pharmaceutical manufacturing facility expansions and launches across Europe. Research by the Confederation of British Industry (CBI) , released in September this year, highlighted progress for UK manufacturing in its latest Industrial Trends Survey.

Pharmaceutical Manufacturing

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.

Vaccines

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. Kazi holds several pharmaceutical industry certifications including post-graduate degrees in Engineering Management and Business Administration. Why is cleaning validation required?

Method Validation

GMPSOP

JULY 31, 2023

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 pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.

Documentation

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. Technologies allow pharmaceutical companies to collect and analyze a massive amount of data to ensure proper drug safety.

Packaging