Pharmacist Digest

Revisiting the Landscape of Potential Nitrosamines in Pharmaceuticals using CPCA framework: Q&A with Naiffer Romero – Part Two

Quality Matters

DECEMBER 8, 2023

Other factors must also be considered, including unknown impurities, chemical structures, reaction mechanisms and treatment benefits. In some cases, the analytical methods used to quantitate NDSRIs may not be sufficiently sensitive to quantify the impurities at limits defined as acceptable for CPCA categories 1 through 3.

Revisiting the Landscape of Potential Nitrosamines in Pharmaceuticals using CPCA framework: Q&A with Naiffer Romero

Quality Matters

NOVEMBER 27, 2023

A: Last year, USP collaborated with a group of scientists from diverse industry and non-profit entities, to conduct an in-silico analysis of more than 12,000 active pharmaceutical ingredients (APIs) and API-related impurities and degradants from the Global Substance Registration System (GSRS). The GSRS is a database hosted by the U.S.

Compounding

Industry examining FDA guidance on nitrosamines

Quality Matters

AUGUST 22, 2023

Long-term exposure to these impurities can increase the risk of developing cancer and, because of this, they have been the subject of great interest and efforts by regulators around the globe to help the pharmaceutical industry control them. ng/day to 1500 ng/day.

Compounding

FDA Sets a Recommended Framework for Predicting the Mutagenic and Carcinogenic Potential of Nitrosamine Drug Substance-Related Impurities

FDA Law Blog: Biosimilars

AUGUST 8, 2023

Lewis, Senior Regulatory Device & Biologics Expert — Please sing to the tune of “ Honesty ,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy.

Compounding

Nitrosamines: the beginning of the end?

European Pharmaceutical Review

SEPTEMBER 5, 2023

Over that time-period the issue has morphed from an API contamination issue of sartans (and other APIs), into concerns about API-related nitrosamines in drug products, ie, nitrosamine drug substance‑related impurities (NDSRIs). He is currently a CMC consultant with an interest in impurities and safety‑based limits. 2020;116: 104749.

Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

JANUARY 29, 2024

In contrast, NDSRIs (N-Nitrosamine drug substance-related impurities) are still a burgeoning issue with many new NDSRIs being reported on a weekly basis. 3 Differences include that potency category 1 in FDA’s CPCA approach is 26.5 3 This serves to highlight the rapidly changing nature of the problem.

Drug Development

Drug Development Vaccines Compounding

Part One: Industry examining FDA guidance on nitrosamines

Quality Matters

AUGUST 23, 2023

Long-term exposure to these impurities can increase the risk of developing cancer and, because of this, they have been the subject of great interest and efforts by regulators around the globe to help the pharmaceutical industry control them. ng/day to 1500 ng/day.

Compounding

FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards

Quality Matters

NOVEMBER 27, 2023

While the FDA has not yet received reports of eye infections associated with these 29 products, the agency published a draft guidance in October 2023 titled “ Quality Considerations for Topical Ophthalmic Drug Products ,” marking the first instance of the FDA providing specific guidance for this product category.

Documentation

Documentation Packaging Dosage

IN FOCUS: Solvias

Pharmaceutical Technology

DECEMBER 9, 2022

The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings. Integrated analytical services for impurities testing. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing.

Vaccines

Rapid method development to overcome challenges of bi-specific antibody purification

European Pharmaceutical Review

JUNE 27, 2022

For development purposes, bsAbs can be divided into two distinct categories depending on the presence or absence of the crystallizable fragment (Fc) region. Consistent with mAbs, bsAbs that possess an Fc region enable the use of well?established established Protein A affinity chromatography purification methods for initial product capture.

Compounding

Clearing the air on liposomes and LNPs in drug delivery

Express Pharma

APRIL 4, 2024

Deep dive into differences: Liposomes vs. LNPs Morphology: In technical terms, LNPs encompass nanoparticles incorporating lipids, with liposomes falling under this category. Within the scientific literature, the term LNP specifically denotes a distinct particle type differing from liposomes in morphology, size, and composition.

Vaccines

Vaccines Compounding Immunity Immunization

Part two: Industry examining FDA guidance on nitrosamines

Quality Matters

AUGUST 29, 2023

In early August, the FDA published its own highly anticipated new guidance, “ Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). ” In this two-part blog series, we take a look at the FDA’s recent guidance on nitrosamines and what it means for industry.In

Compounding

What is meant by reference standard in Pharmaceuticals

GMPSOP

NOVEMBER 6, 2022

Primary reference standard may be utilized for the following purposes: – Potency Standards – to support major component assays – Impurity Standards – to support quantitation of minor components. In general, there will be only one working standard approved for a specific use at any time.

Labelling

Labelling Documentation Packaging Communication

How to perform operational qualification – step by step

GMPSOP

JULY 31, 2023

We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. Category 3: Configurable Software Configurable software is customizable to some extent but does not require full software development.

Documentation

Documentation Dosage Labelling Data Entry

Typical GMP documentation in a quality control laboratory

GMPSOP

APRIL 3, 2023

Types of GMP documents and records used in laboratory We have provided some high level documentation categories in the section above. However, the quality control laboratory has to use broad ranges of documents each of these falls within one of the categories. Following is a list of some commonly used laboratory documentation.

Documentation

Documentation Method Validation Compounding Data Entry

Pharmacist Digest

Revisiting the Landscape of Potential Nitrosamines in Pharmaceuticals using CPCA framework: Q&A with Naiffer Romero – Part Two

Revisiting the Landscape of Potential Nitrosamines in Pharmaceuticals using CPCA framework: Q&A with Naiffer Romero

Trending Sources

Industry examining FDA guidance on nitrosamines

FDA Sets a Recommended Framework for Predicting the Mutagenic and Carcinogenic Potential of Nitrosamine Drug Substance-Related Impurities

Nitrosamines: the beginning of the end?

Pharmaceutical industry: 2023 in retrospect

Part One: Industry examining FDA guidance on nitrosamines

FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards

IN FOCUS: Solvias

Rapid method development to overcome challenges of bi-specific antibody purification

Clearing the air on liposomes and LNPs in drug delivery

Part two: Industry examining FDA guidance on nitrosamines

What is meant by reference standard in Pharmaceuticals

How to perform operational qualification – step by step

Typical GMP documentation in a quality control laboratory

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