The variety of drug-device combination products continues to grow as the trends toward self-administration and personalized medicine drive development of these dosage forms, such as prefilled syringes and auto-injection devices. 

 spoke with Adam Lambert, PhD, vice-president of product and process development at Pharmatech Associates, about current regulatory considerations and best practices in developing combination products.

Pharmaceutical Technology’s September 2021 Regulatory Sourcebook eBook

When referring to this article, please cite it as J. Markarian, “Understanding Combination Product Regulations,” 

Pharmaceutical Technology Regulatory Sourcebook 

Articles

Quality/Regulations

Considering interactions and understanding regulatory requirements are crucial when developing a drug or biologic product for use with a medical device.

Understanding Combination Product Regulations

Titanium dioxide is widely used for adding opacity and brightness in many products. A May 2021 evaluation from the European Food Safety Authority (EFSA), which declared that titanium dioxide is unsafe for food products, alarmed other industries that rely on the ingredient. Although changes are not required in pharmaceutical products, some supplement and drug manufacturers and their suppliers have considered potential alternatives. 

Pharmaceutical Technology’s Regulatory Sourcebook eBook

When referring to this article, please cite it as J. Markarian, “Considering Titanium Dioxide Regulatory Changes,” 

EFSA’s evaluation of risk in food products raises implications for drug product formulations. 

Considering Titanium Dioxide Regulatory Changes

As the COVID-19 pandemic continues, one pressing concern for the industry is ensuring the supply of legitimate COVID-19 vaccines. Now more than ever, the supply chain needs to be secure to ensure the population can have access to legitimate vaccines. But substandard and falsified COVID-19 vaccines—commonly referred to as counterfeit vaccines—continue to be a threat globally.

, September 2021
September 2021
Pages: 10-14

When referring to this article, please cite it as M. Rivers, “The Real Danger of Substandard and Counterfeit COVID-19 Vaccines," 

Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.

The Real Danger of Substandard and Counterfeit COVID-19 Vaccines

Drug shortages were a major concern before the COVID-19 pandemic, which only served to further add pressure to an imperfect supply chain. The COVID-19 pandemic placed added pressure on bio/pharma’s imperfect supply chain, contributing to ongoing drug shortages and creating some new challenges. What has the industry learned from the pandemic and will practices and supply-related decisions change going forward?

Pharmaceutical Technology's September 2021 Regulatory Sourcebook

, September 2021
September 2021
Pages: 16-22

When referring to this article, please cite it as M. Rivers, “Changing the Course of Drug Shortages," 

The COVID-19 pandemic has further impacted ongoing drug shortage issues; essential action is needed to avoid repeating previous mistakes.

Changing the Course of Drug Shortages

For pharma companies and regulators to have meaningful discussion on the results of analyses, they should first agree on the meaning of the terms used. As detailed in Part 1 of this paper, the pharmaceutical industry currently does not have a globally agreed nomenclature for sampling and testing. 

Inconsistent sampling and testing processes that may result from this lack of standardized practices can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality.

In the second part of this paper, the author proposes a simplified overall process flow with associated definitions for pharmaceutical sampling and testing.

Chris Burgess is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

When referring to this article, please cite it as C. Burgess, “Sampling and Testing Nomenclature for Pharmaceutical Analysis: A Simplified Approach," 

Pharmaceutical Technology Regulatory Sourcebook

Analytics

A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed. 

Sampling and Testing Nomenclature for Pharmaceutical Analysis: A Simplified Approach

In pharma applications, consistent sampling and testing nomenclature is critical for data integrity and compliance with specifications and regulatory standards. Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality.

Guidance documents within the pharma industry and other regulated sectors, however, offer conflicting information. This review of regulatory and compendial standards reveals the scope of the problem.

This article provides a review of available analytical nomenclature, recommended naming for individual steps, and terms used in the process flows. Part two of this paper proposes a simplified approach for sampling and testing nomenclature.

When referring to this article, please cite it as C. Burgess, “Sampling and Testing Nomenclature for Pharmaceutical Analysis: A Review of Current Practices," 

Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality. 

Sampling and Testing Nomenclature for Pharmaceutical Analysis: A Review of Current Practices

Pharmaceutical development, manufacturing, and quality efforts are often advanced by the work of industry associations and members through conferences, training sessions, publications, and working groups. These efforts continued during the past 18 months, despite restrictions posed by the COVID-19 pandemic. The American Association of Pharmaceutical Scientists (AAPS) and the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) shared recent activities and industry contributions with 

When referring to this article, please cite it as PharmTech Editors, “Industry Organizations Assist Pharma During the Pandemic and Beyond,” 

Pharmaceutical Technology’s Regulatory Sourcebook

Operations

Pharmaceutical Technology checked in with AAPS and IPEC-Americas to get an update on how the organizations are navigating the pandemic and planning for the future. 

Industry Organizations Assist Pharma During the Pandemic and Beyond

In November 2020, the European Commission (EC) published its 

, which comprises four main objectives: affordable medicines access; support of the European Union’s pharma industry’s competitiveness, innovation, and sustainability; boosting crisis preparedness and response; and strengthening the EU’s global position in pharma. Additionally, as part of its broader strategy, the EC published its roadmap for revising pharmaceutical legislation in March 2021. Here, experts will discuss the strategy in greater detail and will also touch upon the potential for regulatory alignment between the European Union and United Kingdom post-Brexit.

When referring to this article, please cite it as F. Thomas, “Mapping Out Pharma’s Future,” 

There are expectations that changes to pharma regulations in the EU, forming part of the regions broader strategy for the industry, will be positive and should offer flexibility for industry to advance through innovation.

Pharmaceutical Technology, Regulatory Sourcebook, September 2021