Peer-Reviewed Research

The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.

Incorporating structural constraints into pharmacokinetic studies of iron sucrose formulations.

In this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.

In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.

The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.

This study investigated the stability of solid lactose stored under high temperature and humidity conditions.

This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.

The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.

The Uniformity of Dosage Units test is used to evaluate content uniformity or weight variation or dosage forms such as tablets and capsules. The author introduces two different acceptance value limits (n = 10 and 30) in this article.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.

This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.

The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.

Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.

A strengths, weaknesses, opportunities, and threats analysis.

There are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).

A novel method, based on differential calculus, was used to calculate the maximum potential error associated with the drug concentration in pharmaceutical mixtures composed of an infinite number of ingredients measured on an infinite number of balances with different sensitivities. The method was further applied to calculate the ingredients’ least allowable quantities. This approach ensures that the pharmaceutical formulation is prepared within a given maximum permissible error in drug dose.

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.

Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.

Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.

An integrated approach can improve the efficiency of cleaning validation studies.

A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.

Delivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.