SQA Regulatory Surveillance Summary | November 2020 – copy

By Laurel Hacche and Debra Cortner, SQA Associates

Association for the Advancement of Medical Instrumentation (AAMI)

Remote-Controlled Hospital Devices Get COVID-19 Guidance, 28 October 2020

AAMI has published a new consensus report (CR), detailing guidelines for the implementation of remote control for many critical medical devices. Notably, the U.S. Food and Drug Administration (FDA) has already issued emergency use authorizations for many remote devices. AAMI CR511, Emergency use Guidance for Remote Control of Medical Devices, is the latest in a suite of consensus reports that represent the combined expertise of clinicians, the medical device industry, and regulators on AAMI’s COVID-19 Response Team. CR511 focuses on highlighting common system elements for engineers and outlining safety and risk control measures that both manufacturers and caretakers should consider. The document also carefully defines what “remote-control” is when referring to medical devices. In March, the FDA issued a new enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the COVID-19 emergency, followed by emergency use authorizations for certain remote or wearable patient monitoring devices. The rationale is straightforward: if a device or application can reduce how often healthcare providers need to be in the same room as their COVID-19 patients, it will be more difficult for the SARS-CoV-2 virus to spread. However, what remained unclear to device developers was where to begin. The document describes a remote-control innovation as an “auxiliary human machine interface” that allows caretakers to operate a medical device “from a location not co-located with the patient, device, or its primary interface.” This even includes the concept of apps for controlling many devices installed on a common platform, such as a secure tablet.

New Report Guides Drug-Device Combination Risk Management, 02 October 2020

Industry experts and experts from the U.S. Food and Drug Administration (FDA) recently joined forces to take a closer look at the interface of medical device and drug development, called “combination products.” Their new technical information report, AAMI TIR105:2020, Risk Management Guidance for Combination Products, provides recommendations for identifying and proactively avoiding risks to patients and users throughout the life cycle of combination products. “Examples of combination products include mechanical delivery systems and their drug, such as an insulin pump, or when an implantable device is coated with a drug or biologic,” explained John B. Weiner, Associate Director for Policy with the FDA’s Office of Combination Products. “But combination products can also include products that are sold separately and used jointly. Because of the advent of digital health and other innovative drivers, we’re often seeing new examples of combination products and combined uses that may call for specific labeling and collaboration among regulated entities.” Weiner co-chairs the AAMI Standards Committee, which drew up the report. He explained that the reason combination products are on the radar of organizations like AAMI and the FDA is that they have a history of leaving companies unsure about what regulators are looking for.

Sterilization Leaders Pool Knowledge in Unprecedented Collaboration, 31 August 2020

Following a unique collaboration between medical industry leaders, AAMI has published a collection of articles showcasing the best practices and alternative strategies for medical device and packaging sterilization. Shared as an 88-page free resource through AAMI’s journal, Biomedical Instrumentation & Technology (BI&T), the publication offers 11 articles from experts representing a range of influential organizations within the medical industry. These articles recognize the need to make alternative sterilization methods acceptable and available, address known disconnects between product design and processing, and explore challenges impacting patient safety. This compilation of expert knowledge is an important step toward optimization of practices and innovation, as well as helping healthcare companies avoid foreseeable problems affecting product availability and patient safety.

International Organization for Standardization (ISO)

A New ISO Committee for Biocidal Surfaces Has Been Formed to Ensure We Are Fit for the Battle Against Germs, 19 October 2020

According to the World Health Organization, one in ten patients catches an infection while receiving medical care, and effective infection prevention and control reduce healthcare-associated infections by at least 30%. Contamination control to prevent infections and the spread of pathogens is also a key preoccupation in many other industries, such as animal health, food, farming, cosmetics, transport, and more. Biocidal surfaces are a valuable tool because they destroy or inactivate unwanted pathogens, thus contributing to a cleaner environment. However, the performance of such surfaces can vary, giving rise to the need for effective guidelines and test methods to ensure they are up to scratch. The newly created ISO expert committee, ISO/TC 330, Surfaces with Biocidal and Antimicrobial Properties, aims to resolve such inconsistencies by developing internationally agreed requirements and guidance. Its purpose is to develop standards for test methods to assess the biocidal performance and efficacy of any surfaces with antimicrobial activities, as well as their compatibility with different disinfectants and cleaning agents.

The Specification for Barcodes on Medication Packaging Has Just Been Updated, 06 October 2020

The correct identification, labeling, and tracking of medicinal products throughout the entire supply chain is essential to prevent fraudulent pills from sneaking onto the market. International machine-readable coding of product packaging is an effective way of achieving that, and the international technical specification (TS) for it has recently been revised. ISO/TS 16791Health Informatics – Requirements for International Machine-Readable Coding of Medicinal Product Package Identifiers, outlines everything manufacturers and regulators need to know to implement barcodes on medicinal packaging and is applicable to Automatic Identification and Data Capture (AIDC) technologies. It complements the ISO series of standards for the Identification of Medicinal Products (IDMP) that covers various regulatory requirements such as those related to development, registration, and life-cycle management.

International Standard for Medical Device Testing Updated, 30 July 2020

Clinical investigation of medical devices is highly regulated, with numerous national and regional rules and requirements that must be adhered to by manufacturers and investigators, as well as other parties involved in clinical trials. ISO 14155Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice, helps manufacturers comply with the requirements for Good Clinical Practice in the design, conduct, and reporting of clinical investigations. Widely used across the industry, ISO 14155 has been revised to align with recent regulatory changes and amendments to other relevant standards. It also features a host of additional details and information designed to help protect participants in clinical trials and medical device users and to achieve sound results. The standard safeguards the rights, safety, and wellbeing of trial participants and includes requirements for appropriate methodology that ensures the scientific credibility of clinical data. It defines the responsibilities of sponsors and investigators and explains the role of ethics committees, regulatory authorities, safety boards, and other parties involved.

International Pharmaceutical Excipients Council (IPEC) and The Pharmaceutical Quality Group (PQG)

The Joint IPEC-PQG Good Manufacturing Practices Guide, 18 November 2020

Within the IPEC Federation, a project is ongoing to revise The Joint IPEC-PQG Good Manufacturing Practices Guide, 2017 to align the contents with the most recently published ISO 9001 standard on Quality Management (2015). In addition, more examples will be added as an Annex to help readers better apply GMP principles to the manufacture of excipients. This exercise has proven to be very resource intensive; however, considerable efforts are being made to ensure that the new revision is finalized in the near term, with the goal of publishing the next version early in 2021.

GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients, 12 November 2020

The IPEC Federation announced the availability of the new International Pharmaceutical Excipients Council GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients. The guide was developed for excipient users (e.g., pharmaceutical manufacturers) to qualify certification bodies (CB) that issue excipient GMP and GDP certificates and audit reports as well as Certification Scheme Owners. The use of the guide is intended to facilitate sharing pertinent information from the CBs and Scheme Owners to excipient users in a standardized way. The guide and its associated “sample” template were designed to facilitate the provision of standardized information from the CB or Scheme Owner to the excipient user. This will accelerate communication between all parties, helping consistency in the level and type of information/documentation required to prevent multiple diverse questionnaires/information requests from different excipient users. Qualifying the CB and/or the Scheme Owner should facilitate the acceptance of excipient GMP and GDP certification schemes, audit reports, and certificates that may substitute for audits otherwise performed by the excipient users. A template for the certification body is included.

The guide will be available, initially exclusively to IPEC members for a three-month period, on the IPEC Federation and national/regional members’ websites. Thereafter, the guide will be made available to the general public.

New IPEC Guide: Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design (QbD), 03 November 2020

The IPEC Federation announced the availability of a new guide: Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design (QbD guide). The primary goal of the QbD guide is to:

  • Introduce QbD and pharmaceutical formulation development concepts to excipient manufacturers and suppliers
  • Explain how changes in pharmaceutical formulation practices, due to the introduction of QbD, impact excipient manufacturers and suppliers
  • Help excipient manufacturers and suppliers understand what excipient users will likely require when applying QbD principles during product development
  • Explain to excipient users and regulatory agencies what may or may not be possible when considering the impact of excipient variability in the application of QbD principles during product development

This guide includes some recommendations related to the impact of excipient variability on drug product quality during development and how excipient variability can be managed in the control strategy. It contains useful explanations and suggestions for pharmaceutical excipient makers and users. The Guide is applicable to excipient use throughout the pharmaceutical product development process using a QbD approach described by the International Council on Harmonization (ICH) Q8, as well as other applicable ICH Guidelines such as ICH Q9, Q10, Q11, and Q12.

The guide will be available, initially exclusively to IPEC members for a three-month period, on the IPEC Federation and national/regional members’ websites. Thereafter, the guide will be made available to the general public.

Parenteral Drug Association (PDA)

Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (TR 84), September 2020

PDA Technical Report No. 84 (TR 84) addresses data integrity from the perspective of manufacturing operations. It discusses regulatory trends, risk management concepts, and recommendations for implementing appropriate data integrity controls in manufacturing operations applicable to paper-based, electronic, and hybrid systems. The case studies included in this technical report provide examples of how to assess current data integrity risks and implement the concepts presented in the report. TR 84 describes an approach using quality risk management (QRM) for establishing and assessing the appropriateness of data integrity controls for each manufacturing operation based on the criticality and vulnerability of the data for its intended use. 

Developed by subject matter experts from global industry and regulatory agencies, TR 84 summarizes manufacturing data integrity risks and identifies best practices that can be used to develop and sustain robust documentation, as well as data integrity management procedures, systems, processes, and controls. Employing these practices will help users achieve compliance with applicable laws, regulations, and directives for pharmaceutical products such as active pharmaceutical ingredients (APIs), solid oral dosage forms, sterile injectables, biologics, and vaccines.

Fundamentals of an Environmental Monitoring Program, Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products (TR 13-2), November 2020

PDA Technical Report No. 13-2 (TR 13-2) is an addendum to PDA Technical Report No. 13 (TR 13, Revised 2014): Fundamentals of an Environmental Monitoring Program, which focuses on the environmental requirements for sterile product manufacturing. This addendum complements the existing TR 13 by providing elements to consider when designing a risk-based environmental monitoring program to support the manufacture of low bioburden products using low bioburden processes. This new resource offers a means of determining the critical aspects, assessing the associated risks, and designing the appropriate environmental monitoring program for areas where bioburden control of manufacturing processes is required.

TR 13-2 provides recommendations for the development of an environmental control and monitoring program for classified areas and the associated GMP processes used for manufacturing operations requiring bioburden control in the biotechnology and pharmaceutical industries. A review of regulatory requirements and the development of risk assessments based on the criticality and complexity of processes is included, along with industry examples of these risk-based approaches. This TR is not intended to address environmental monitoring programs for traditional aseptic or sterile manufacturing, which are covered in TR-13, nor does it address traditional nonsterile dosage forms.

Personal Care Product Council (PCPC)

Transparency and Compliance in the Supply Chain, 07 October 2020

Members of PCPC are united in their commitment to operate responsibly and integrate sustainable practices along the entire value chain. As part of PCPC’s efforts to advance the capabilities, know-how, and understanding of best practices, a sustainability-focused webinar series for members was recently launched, the most recent of which focused on transparency and compliance in the supply chain. Webinar guest speaker Sandy Gray, Supply Chain Sustainability Solutions at EcoVadis, a Corporate Social Responsibility (CSR) risk monitoring and sustainability rating platform, noted that beauty and cosmetics manufacturers must consider sustainability throughout the product lifecycle, from raw materials and manufacturing to packaging, distribution, and retail, as more than two thirds of many beauty and personal care products’ environmental impacts occur upstream in the supply chain.

Transparency in the supply chain is particularly important to consumers, as 73% say transparency is valuable to them and a majority say they are more likely or very likely to pay more for products from companies that operate in a more transparent manner. The beauty and personal care products industry is leading the way with several initiatives to promote sustainability, transparency, and compliance, which leverage science-based and collaborative approaches, including the following:

  • The Responsible Beauty Initiative pre-competitive industry program focuses on improving sustainability throughout the entire beauty supply chain by sharing best practices and processes, driving a common understanding across the industry, and creating efficiencies through the use and sharing of common tools.
  • The Sustainable Packaging Initiative for Cosmetics (SPICE) pre-competitive industry program aims to define harmonized guidelines for sustainable packaging and create approaches and innovations based on eco-design.
  • The Science-Based Targets Initiative (SBTi) requires GHG emission reduction targets to be adopted by companies to meet the goals of the Paris Agreement to limit global warming to well below 2°C above pre-industrial levels.
  • CDP (formerly the Carbon Disclosure Project) is a recognized global system for companies to measure, disclose, manage, and share carbon emissions and other material environmental information.

Innovations in Sustainable Packaging, 10 November 2020

As public and regulatory concerns about single-use packaging waste increase, consumer goods companies are proactively taking steps and making commitments to improve the sustainability of their packaging while also rethinking packaging systems. Focused for decades primarily on convenience, consumers are increasingly aware of packaging waste that ends up in oceans and landfills. Companies are working together, pre-competitively, on systems-level approaches with a common understanding of the challenges and need for collaboration along the entire packaging value chain. The beauty and personal care industry is taking numerous actions to reduce its use of plastic packaging, use more recycled plastic, and increase the recyclability of plastic packaging. Last year, PCPC joined the SPICE as an associate member. SPICE, co-founded by Quantis and L’Oréal, brings together organizations in the cosmetics sector to work towards a common goal of shaping the future of sustainable packaging. SPICE develops and publishes business-oriented methodologies and data to support decision-making to improve the environmental performance of product packaging.

As part of continued efforts to advance the capabilities, know-how, and understanding of sustainability best practices, PCPC recently hosted a webinar on sustainable packaging, focusing on trends and business drivers, an introduction to SPICE, and a demonstration of its new open source sustainable packaging tool. Webinar guest speaker Dimitri Caudrelier, CEO of Quantis, a global sustainability consulting firm, demonstrated a new eco-design webtool to help companies assess the environmental performance of packaging based on an industry-aligned methodology. The tool features an easy-to-use interface developed specifically for cosmetics packaging designers and engineers and can:

  • Calculate the footprint of any cosmetics package, create an aggregate score for that package, and detail its environmental performance by stage in the lifecycle
  • Simulate multiple materials and design scenarios to assess ways to reduce a package’s impact and help evaluate different packaging approaches (single-use, recharge/refill systems)
  • Inform a company’s sustainable packaging policy, goals, and progress

Pharmaceutical Inspection Co-Operation Scheme (PIC/S)

Brazil/ANVISA Joins PIC/S, 30 November 2020

The PIC/S Committee has invited Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) to join the PIC Scheme. Brazil/ANVISA will become PIC/S’s 54th Participating Authority as of 01 January 2021. ANVISA submitted a complete membership application in October 2014. A paper assessment was carried out, followed by an on-site assessment visit that took place in October 2019, after a reorganization at ANVISA. The assessment report was finalized in the course of 2020. The audit team recommended that the Committee accept the PIC/S membership application of ANVISA. After endorsement by the PIC/S Sub-Committee on Compliance (SCC), the PIC/S Committee unanimously decided by written procedure (completed on 27 November 2020) to accept the participation of ANVISA in PIC/S. This is the first time in PIC/S’s history that an assessment process was completed by written procedure rather than at a Committee meeting. This was due to the situation with COVID-19, which prevented a Committee meeting taking place in 2020. A special welcome will be given to ANVISA at the next PIC/S virtual Committee meeting in 2021.

World Health Organization (WHO)

54th Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations, Technical Report Series 1025, 21 April 2020

The WHO Technical Report Series makes available the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on a broad range of medical and public health subjects. Members of such expert groups serve without remuneration in their personal capacities rather than as representatives of governments or other bodies; their views do not necessarily reflect the decisions or the stated policy of WHO. The 54th Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations, Technical Report Series 1025 (TR 1025) focuses on the following topics:

  • Quality Control Specifications and Tests: International Pharmacopoeia – Development of Monographs and International Chemical Reference Substances
  • Quality Assurance: Good Manufacturing Practices and Inspection
  • Quality Assurance: Distribution and Supply Chain
  • Regulatory Guidance and Model Schemes