Blogs

Previous Blogs

Explore NMPA's new guidelines and West's solutions for improved generic injection quality and packaging.

By Qian Liu

May 22, 2024

To improve the consistent evaluation of the quality and efficacy of generic drugs for injections, National Medical Products Administration of China(NMPA)published the guidance “Technical Requirement for Quality and Efficacy Consistency Evaluation on Chemical Generic Injections” (21 October 2020), which indicates the beginning of injection consistency evaluation. This guidance clarifies the specific technical requirements on reference-listed drugs, prescription technology, quality control of bulk drugs and excipient packaging, quality studies and control, stability studies, etc.
Container Closure Integrity (CCI) is one of the key factors for the quality and safety of the entire product lifecycle of pharmaceuticals. To better address this topic, NMPA issued “Technical Guide for Research on Package Integrity of Chemical Injections (Trial)” on 21 October 2020. And 4 years later, “9650 Guidelines for Research on Pharmaceutical Package Integrity” is published as Chinese Pharmacopoeia (ChP) 2025 chapter on 19 Feb 2024. This new publicity helps to guide the implementation of CCI of pharmaceutical packaging materials and provides effective ways to comprehensively assure the quality of drugs.

West Waterford team members volunteering in local schools to deliver hands-on learning experiences

By Catriona Kennedy

May 08, 2024

The West Waterford team partnered with Junior Achievement Ireland (JAI) as their capstone charity of choice in 2023. This partnership gives West the opportunity to give back to communities in the South-East region of Ireland through providing a combination of funding support and volunteers.

Explore West's comprehensive guide to extractables and leachables in pharmaceutical packaging

By Will Parker

April 23, 2024

Focus on extractables and leachables (E&L) from packaging and delivery systems began in the mid-1990s but, since then, regulatory agencies have become more educated, and expectations of the pharmaceutical industry have increased. Examples of updated recommendations include USP<1663> and <1664> and injectable drug recommendations from Product Quality Research Institute (PQRI). Complex drug product formulations have become more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and drug product.

Recent FDA Guidance, Combination Products by Lauren Orme, Director of Regulatory Policy & Intelligence

By Lauren Orme

April 11, 2024

On September 7th, 2023, a long-awaited final guidance was issued by the Food and Drug Administration (FDA) - Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. The document is intended to be used in conjunction with other human factors related guidance and available national and international standards, such as AAMI HE75 and IEC 62366. In this latest guidance, the agency provides its view on best practices for conducting human factors activities for combination products either comprised of a device and a drug or a device and biologic.

FDA’s Final Rule Overview of Quality System (QS)

By Fred Cowdery

March 28, 2024

In 1987, the International Organization for Standardization (ISO) issued the first version of ISO 9001, a standard intended to define the basic requirements, structure, responsibilities, and procedures required to implement an effective quality management system for manufacturing organizations in general. In 1996, the International Organization for Standardization issued the first version of ISO 13485, “Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001,” to specify, in conjunction with the application of ISO 9001, the Quality Management System (QMS) requirements for medical device manufacturers. Today, ISO 13485 is used internationally by many regulatory authorities as the foundation for defining regulatory QMS requirements for medical device manufacturers and is utilized in regulatory harmonization programs such as the Medical Device Single Audit Program (MDSAP).

Prefillable Syringes Regulatory Guidelines- overview by Bettine Boltres PhD., Director, Scientific Affairs & Technical Solutions, Glass Systems

By Bettine Boltres

March 14, 2024

Have you successfully developed a drug product in a prefilled syringe and are now wondering how to get it on the European market?
According to the European Union Regulation (EU) 2017/745 (MDR) Article 1(9), a prefilled syringe (PFS) is identified as “a single integral product which is intended exclusively for use in the given combination, and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable” (1). According to 2017/745 Article 1(9), you must prove that the device part of your combination product complies with the appropriate General Safety and Performance Requirements (GSPRs) laid out in Annex I of MDR. As you can no longer do a self-assessment, you will need to reach out to one of the currently designated 43 Notified Bodies in Europe (2) to do the conformity assessment for you. The results of the assessment are then captured in the Notified Body Opinion (NBOp) which you are required to include in the submission file to EMA or your national competent authority.