European Pharmaceutical Review

OCTOBER 23, 2023

1 In pharmaceutical manufacturing, the high level of final product quality is the major driver. Tablets should be defect-free and compliant to good manufacturing practice (GMP) aspects and final-user requirements. In tablet compression, there are a range of factors which contribute to a successful production run.

Compounding 98

Compounding Pharmaceutical Manufacturing 98

pharmaphorum

MARCH 29, 2021

This is not the only attempt to revive research into antibiotics: last year more than 20 big pharma companies joined to create the AMR Action Fund , where they joined forces with philanthropists, development banks and other organisations to find new compounds.

Pharmaceutical Manufacturing 64

Pharmaceutical Manufacturing Compounding 64

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 compounds used in the pharmaceutical production are exposed to a wide variety of stresses. Thus, formulation dust containing HPAPIs is a major problem concerning potential exposure.

Dosage 105

Dosage Pharmaceutical Manufacturing Compounding 105

European Pharmaceutical Review

DECEMBER 21, 2022

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. Defossilization of pharmaceutical manufacturing.

Compounding 97

Compounding Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 97

European Pharmaceutical Review

JULY 5, 2022

Bacterial spores are a significant concern for aseptic pharmaceutical manufacturers due to their ubiquitous nature and intrinsic resistance to environmental stressors such as heat, as well as chemical and radiation inactivating strategies.

Pharmaceutical Manufacturing 98

Pharmaceutical Manufacturing Compounding 98

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.

Diabetes 111

Diabetes Dosage Pharmaceutical Manufacturing Documentation 111

pharmaphorum

DECEMBER 16, 2022

Compounding the situation to understand how such an outcome was allowed to occur is the fact that many deals between government and pharmaceutical companies selling the treatments and vaccines were agreed under terms of confidentiality. The discussions over the treaty are set to continue for some time.

Vaccines 96

Vaccines Pharmaceutical Manufacturing Labelling Compounding 96

GMPSOP

FEBRUARY 28, 2024

Sometimes, pharmaceutical manufacturers employ surface profilometry to assess the roughness of stainless-steel equipment. Ammonium Compounds: Quaternary ammonium compounds, such as Benzalkonium chloride, act as disinfectants and surfactants. Protease, amylase, or lipase enzymes). if used on pre-cleaned surfaces.

Documentation 98

Documentation Packaging Pharmaceutical Manufacturing Compounding 98

Quality Matters

OCTOBER 13, 2021

In addition to standards for active pharmaceutical ingredients, USP also develops standards for the inactive ingredients (excipients) and other raw materials used in drug manufacturing. In a 2019 report on drug shortages, the FDA found that 62% of drug shortages occur because of quality issues in manufacturing.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Adverse Reactions Prescription Filling Compounding 52

pharmaphorum

AUGUST 24, 2020

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Compounding Immunization Immunity 52

Quality Matters

SEPTEMBER 15, 2023

The manufacturer must perform test B “Limit of Diethylene Glycol and Ethylene Glycol” to check whether DEG and EG content is no more than 0.10 % prior to use, and not use it if the level is higher than 0.10 %. Regulatory agencies in different countries can use the U.S.

Documentation 52

Documentation Compounding Pharmaceutical Manufacturing 52

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.

Packaging 52

Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 52

GMPSOP

MAY 17, 2024

Sometimes, pharmaceutical manufacturers employ surface profilometry to assess the roughness of stainless-steel equipment. Ammonium Compounds: Quaternary ammonium compounds, such as Benzalkonium chloride, act as disinfectants and surfactants. Protease, amylase, or lipase enzymes). if used on pre-cleaned surfaces.

Documentation 52

Documentation Packaging Pharmaceutical Manufacturing Compounding 52

Pharmaceutical Technology

MAY 11, 2008

” Laser marking solution company Datalase has developed a system where an inactive compound can be added to the tablet formulation. ” LEVEL TRACKING Pharmaceutical manufacturing company Seidenader Vision has also developed a system – the SATrack and Trace.

Packaging 40

Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 40

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.

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

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 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

MAY 31, 2024

The validation plan applies to all existing and new drug compounds and registered drug products or active pharmaceutical ingredients (APIs) for clinical use or sale. The validation master plan in the pharmaceutical industry must provide evidence that the following major changes comply with regulatory expectations.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

GMPSOP

JUNE 9, 2024

Certain laboratory reagents are categorized as dangerous commodities, including but not limited to explosives and gases, combustible compounds, peroxides and oxidizing agents, infectious substances and poisons, radioactive materials, and corrosives. Reagents should only be used for the purposes for which they were designed.

Method Validation 52

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. – Gas Chromatography (GC) Systems (Critical for analyzing volatile compounds). When is equipment qualification necessary?

Documentation 52

Documentation Dosage Labelling Data Entry 52

GMPSOP

JULY 14, 2023

In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. What you will need are properly validated equipment cleaning procedures and a well-defined cleaning and verification regime in order to make sure your products are free from unnecessary contaminants.

Documentation 52

Documentation Labelling Pharmaceutical Manufacturing Packaging 52

Express Pharma

DECEMBER 13, 2024

Pathways of pharmaceutical pollution Pharmaceuticals enter the environment through several main routes, each exacerbating the growing issue of contamination in our water, soil, and air.

Compounding 102

Compounding Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 102

Express Pharma

NOVEMBER 28, 2024

Excipients are essential to the stability, bioavailability, and efficacy of active pharmaceutical ingredients (APIs) and the global excipients market is expected to grow at a compound annual growth rate (CAGR) of 6 to 7 per cent.

Vaccines 105

Vaccines Pharmaceutical Manufacturing Packaging Compounding 105