The FDA sends Warning Letters and 483s to companies that significantly violate FDA regulations. We gather those related to computer system issues so that you can help ensure your organization doesn’t fail an inspection for similar violations. Organizations who received warning letters citing computer system issues: F.P. Rubinstein Y Cia This Warning Letter contains many observations impacting software quality, including … Read more
In mid-2016, the World Health Organization (WHO) published the 2nd draft of Global Model Regulatory Framework for Medical Devices including IVDs. This document is intended to provide guidance to WHO Member States in developing and implementing regulatory controls relating to medical devices to ensure the quality and safety of medical devices. Since many modern medical devices contain software, developers of … Read more
In September, the FDA published Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients to provide API manufacturers with recommendations intended to ensure compliance with regulations. What is in the new FDA Guidance: This guidance document, originally published by ICH in 2000, includes recommended best practices for computer systems, such as: Validation System documentation Security Record protection and retention Audit trails … Read more
Last month, the EMA’s Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group published their answers to 23 frequently asked questions related to Data Integrity and the Data Life Cycle. EMA’s Recommendations This Q&A document provides insight in the EU regulators’ expectations regarding data risk assessment and mitigation; data security, protection, and retention; electronic signatures; electronic data review; … Read more
Earlier this year, the FDA published draft guidance on Data Integrity and Compliance for GMP. And now PIC/S has published a new, draft document Good Practices for Data Management and Integrity to guide manufacturers of medicinal products in complying with GMP and GDP requirements. As a member of PIC/S, the US FDA participated in the development of this guidance. The draft … Read more
In July 2016, the FDA released Guidance for Industry and FDA Staff – General Wellness: Policy for Low-Risk Devices to clarify compliance policies for low risk products that promote a healthy lifestyle. What’s in this FDA guidance document: The purpose of a general wellness product According to this FDA guidance, a general wellness product must Be intended only for general … Read more
The FDA just published a new, draft guidance document on good manufacturing practices (cGMP) for drugs. This document is intended to address the frequent data integrity issues found during FDA inspection of pharmaceutical and API manufacturing sites. What’s new in this draft FDA guidance document: Clarifications & Definitions of Terms This draft guidance contains clarifications and definitions for the terms … Read more
In January the FDA published draft cybersecurity recommendations for marketed medical devices to protect patient safety. What’s new in this draft FDA guidance document: Manufacturer’s Responsibilities This guidance emphasizes that medical device manufacturers should monitor, identify and address cybersecurity vulnerabilities. This draft FDA document highlights that it is essential for device manufacturers to implement comprehensive cybersecurity risk management programs. These … Read more
If your electronic medical device exchanges data with other devices, you need to read the new draft guidance just published by the FDA. This document contains recommendations intended to promote the safe and effective exchange of information between devices. Make sure you and your team are aware of these best practices, so you can incorporate them into your medical device. … Read more
In October, a new version of Annex 16 was published due to significant changes in the globalization of pharmaceutical supply chains and the introduction of new quality control strategies. Annex 16 was last published in 2001, so this version has significant improvements. The deadline for compliance with this version of Annex 16 is 15-APR-2016. What’s in this new version: This version … Read more
Recently, the FDA drafted this guidance document to help the medical device industry make decisions around manufacturing site changes. This guidance is intended to help in managing the time frames for changes in manufacturing sites and the associate changes to processes, methods, procedures, qualifications and validations by helping industry predict when an FDA pre-approval inspection is likely to be required for … Read more
In September 2015, the World Health Organization (WHO) published a draft guidance document focused solely on data integrity. This is due to recent increases in the number of inspection observations related to data management practices. These WHO recommendations are intended to ensure the integrity of both paper and electronic data and records. Share this with your team, so you can … Read more
Last month, the FDA published this document for drug and biological license applicants submitting analytical procedures and methods validation data to document the identity, strength, quality, purity, and potency of drug substances and products. This guidance is intended to complement the International Conference on Harmonisation (ICH) guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology for developing and validating analytical methods. Computer and software related … Read more
R2 of E6 Good Clinical Practice has been published for consultation. Once approved, it will replace the original R1 version of E6. What’s included in this revision: E6 R2 contains updates intended to increase clinical trial quality and efficiency. The objective of this draft ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United … Read more
