Quality Assurance/Quality Control

This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.

This article explores the concerns with cleaning pharmaceutical products utilizing LNP delivery vehicles and provides a general cleaning recommendation based on laboratory and field testing.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.

FDA continues efforts to incentivize drug manufacturers to follow higher data integrity requirements.

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

In this episode of Drug Digest, Pharmaceutical Technology editors, Felicity Thomas and Feliza Mirasol, examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements.

Using more exacting analytical tools can give a clearer assessment of gene-editing outcomes.

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

The move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.

Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.

Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.

Exhibitors display primary packaging, secondary packaging, and machine innovations at this year’s INTERPHEX.

FDA is reviving efforts to establish a Quality Management Maturity program.

Pharmaceutical Technology asked Jeff Elton, PhD, CEO of ConcertAI, about the role technology plays in performing CAPAs.

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.

Standardization is needed in CAR-T cell therapy development due to its inherent complexity.

The author introduces a practical approach to determining the best estimate of probability for passing multiple stage dissolution tests.

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. Pharmaceutical Technology asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.

Data may be used to improve (or remove) a corrective action/preventive action.

Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.

Any improper validation of methods is likely to result in regulatory agency deficiencies that range in degree of severity.

Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.

The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications.

Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape.

A consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines.

Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.

Training is crucial for supporting GMP operations in commercial-scale bioprocessing.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.