It has been more than twelve years since the concept of Data Integrity was introduced formally to industry, and widely discussed throughout the industry, and yet, to this day, we continue to see how industry struggles with it. This blog post discusses some of the fundamental topics clarifying what data integrity is and how to […]
At Lachman Consultant Services, we pride ourselves on being a preferred partner for quality, compliance, and regulatory consulting services for the life-sciences sector. However, we provide services to every sector regulated by the FDA except food and tobacco, and there are a lot of changes coming down the pike in the regulation of cosmetic products […]
The bulk of microbiology attention in the drug manufacturing world is laser focused on sterile drug products and the myriad steps needed to aseptically manufacture them. That is certainly with good reason as those drug products carry the highest patient risk should there be microbial contamination. One aseptic manufacturing misstep and the consequences could be […]
Bring up the recently updated and finalized EU Annex 1 – Manufacture of Sterile Medicinal Drug Products (here) in polite pharmaceutical water cooler conversation and a frequent topic that comes up is the Contamination Control Strategy (CCS) language. Buzzwords abound for a “holistic”, “global”, or “wholesale” CCS to be incorporated into all elements of aseptic […]
The FDA issued a guidance today entitled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (here) announcing a 6-month period during which the FDA will not take compliance actions against a company for failing to meet the cosmetic listing and facility registration requirements. According to the FDA, the policy is designed to […]
The EU has continued its advancement of initiatives and intentions to combat the drug shortage problem. The latest communication is titled “Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Addressing medicine shortages in the EU” (here). This is a deep dive […]
The artificial intelligence paradigm shift is taking what was once a wish into reality, specifically, cross-regulatory agency coordination and harmonization. The latest publication in this area is a joint effort of the U.S. Food and Drug Administration (FDA), U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada to define guiding principles in AI […]
Did you ever want to do something to help half a million consumers (on average) who are impacted by a drug shortages? This may seem daunting and based on the last few years almost impossible, but the first step is clear: increase your or your company’s awareness of the situation. Knowledge is power. Lachman is […]
Another beautiful fall day in Bethesda and a great start to this year’s conference. Since I can only be in one place at a time (although my wife would beg to differ), I will give you some highlights from day 1. And next year, you should attend this meeting as this is the premiere event for […]
The FDA has issued a white paper on “CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development.” The paper details a program the center intends to establish whereby the goal is to promote QMM throughout the industry. Lachman recently issued a blog relating to this initiative that can be found here. […]
