COETIC votre partenaire pour la gestion et la validation de vos projets réglementés GxP

Posted by: Mark Birse ,  Posted on: 31 October 2019  -  Categories: Compliance matters ,  Events and symposia ,  Good clinical practice ,  Good distribution practice ,  Good laboratory practice ,  Good manufacturing practice ,  Good pharmacovigilance practice ,  Wider MHRA I’ve always had a keen interest in all things digital.  It probably started from when I bought my first computer in 1981 (albeit a 1K  ZX81 ) whilst still at primary school.  My coding as child on that first machine did not get much better than 10     PRINT “Mark is Cool” 20     GOTO 10 but, it gave me a lifelong interest in technology... Plus d'information ici

2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). You did not have a procedure governing  (b)(4)  of High Performance Liquid Chromatography (HPLC) data. Additionally, your procedure did not require the same number of replicate HPLC injections ( (b)(4) ) to average and obtain a final result. Our investigators identified several examples of your firm using  (b)(4)  and reporting passing results without adequate procedural controls or justification. For instance, Deb Pure Bac Foam Wash, lot 049559, initially failed during  (b)(4)  and upon  (b)(4)  yielded a passing result that was reported... 3. Your firm failed to establish and follow required labor

Présentation exclusive ce jour au salon PDA (Parental Drug Association) en Suède de cette nouvelle solution connectée auprès de clients et prospects internationaux Issoire, le 22 octobre 2019, à 7h30 CEST – BIOCORP (FR0012788065 – ALCOR / Éligible PEA PME), société française spécialisée dans le développement et la fabrication de dispositifs médicaux et de systèmes d’administration de médicaments injectés, présente aujourd’hui à Göteborg (Suède) au salon international PDA (Parental Drug Association) son tout nouveau dispositif Injay permettant de faire évoluer toute seringue pré-remplie en dispositif connecté. Les seringues pré-remplies (PFS) sont aujourd’hui utilisées partout dans le monde pour une administration plus précise de médicaments parentéraux. Avec une croissance annuelle proche de 10%, le marché représente aujourd’hui 11 mds USD /an. Plus d'information ici  

21 October 2019 Rev.1 EMA/37991/2019 Human Medicines Evaluation Division Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations. Plus d'information ici .

Technologie :  Avec l'acquisition de Medidata Solutions, Dassault Systèmes souhaite appliquer la recette des jumeaux numériques au secteur de la santé. De quoi révolutionner le secteur ? Par  Pierre Benhamou   |  Mardi 29 Octobre 2019 Suivre @pierrebnhu   0 Réactions Partager plus + Quelques mois après avoir annoncé ce mariage, Dassault Systèmes a indiqué ce mercredi avoir finalement reçu l'aval des autorités américaines  pour finaliser l’acquisition de Medidata Solutions , au terme d'une opération valorisée à 5,8 milliards de dollars. Plus d'information ici . 

PUBLIC CONSULTATION: Working document QAS/19.819: GUIDELINE ON DATA INTEGRITY - Request for comments by 15 January 2020 L'OMS invite les personnes concernées à examiner le projet de document de travail ci-après , qui sera affiché sur le site web du médicament de l’OMS sous «Projets en cours» (http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/). «LIGNE DIRECTRICE SUR L’INTÉGRITÉ DES DONNÉES» Date limite de commentaires: 15 janvier 2020 Les commentaires doivent être envoyés à Mme Sabine Kopp (kopps@who.int), avec copie à Mme Claire Vogel à l'adresse vogelc@who.int à l'aide de ce formulaire . Seuls les commentaires reçus à la date limite susmentionnée seront pris en compte lors de la préparation de ce projet de document de travail.

Les faits  Le ministère américain de la Défense a finalement attribué à Microsoft, vendredi 25 octobre, un énorme contrat pour assurer le stockage de ses données en ligne au détriment d’Amazon. La Croix (avec AFP) ,  le  26/10/2019 à 11:29 Plus d'information ici

ALCOA+ and Data Integrity Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates. Oct 02, 2019 By  Susan J. Schniepp Pharmaceutical Technology Volume 43, Issue 10, pg 77 Q: I am familiar with the term ALCOA as it relates to data integrity, but lately, I have heard people refer to ALCOA+. Can you explain what impact this new acronym has on my company’s data integrity program? La suite ici  

Sanofi's new bio-manufacturing site in Framingham is completely digital, with all of the processes being records on tablets. Each piece of equipment has a QR code that can be scanned, allowing employees to remotely control things like temperature. Article de Peter Gumaskas Lien

Using Software in Process Validation Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction. Oct 01, 2019 By  Robert Glaser BioPharm International Volume 32, Issue 10, pg 22–25 JohanSwanepoel - Stock.Adobe.com Within pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step to ensure consistent product quality. It seems straightforward, but how does one achieve this when it involves a myriad of multiple systems (programmable logic controllers [PLCs], human-machine interfaces [HMIs], control systems, etc.) and requires a team effort that encompasses people from various disciplines within the plant? It is important to design processes that ensure product quality, safety, and efficacy. Today’s software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right way. Fo

By  Kip Wolf , Tunnell Consulting,  @KipWolf The idea for machines that can think became the topic of science fiction in the early parts of the 20 th  century and made for interesting reads. Science caught up and the term “artificial intelligence” (AI) was coined by John McCarthy at the Dartmouth Summer Research Project on Artificial Intelligence (DSRPAI) in 1956, where the first AI program, the  Logic Theorist , was presented by Allen Newell, Cliff Shaw, and Herbert Simon. 1 AI research flourished in the early years until it was slowed by limits in computational power, but it was reinvigorated in the 1980s by both computational tools and investment when John Hopfield and David Rumelhart popularized deep learning techniques that allowed computers to learn using experience. 1  The next limitation to AI advancement was in computer storage, which by the late 1990s was no longer a problem, as storage advancements produced cheap and ubiquitous solutions. In our modern world, we carr

1.  Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188). Compression machine process control values were not adequately reported in your batch production records during the manufacture of  (b)(4)  mg tablets intended for the U.S. market. Your quality unit used these deficient records to release batches of this drug product. While multiple batch records of  (b)(4)  mg tablet included handwritten values routinely within process parameters, the values recorded by the programmable logic controller (PLC) of your compression machine were frequently outside your established process parameters. For example,  (b)(4)  mg batch  (b)(4)  had compression force values handwritten  (b)(4)  in the batch record ranging from  (b)(4)  (your limit was  (b)(4) ). However, the PLC data recorded individual values ranging from  (b)(4)  for the same time period. In add

CGMP Violations 1.  Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR  211.22 (a)). During our inspection of your facility, your quality staff provided multiple quality documents to our investigator. Based on concerns with the documents provided, our investigator questioned your Quality Manager regarding the validity of these documents. Your General Manager and Quality Manager, then stated that multiple documents provided were in fact falsified “for the purpose of this inspection.” Falsified documents include cleaning validation reports, batch records for multiple drug products, and annual product reviews. Furthermore, you also stated that you could not provide basic records to support the CGMP requirements for the manufacture of drugs, including, but not limited to, the fo

CGMP Violations 1.    Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). You invalidated out-of-specification (OOS) test results for assay for  (b)(4) , active pharmaceutical ingredient (API) (batches  (b)(4)  and  (b)(4) ) without scientific justification. Batch  (b)(4)  of this API was subsequently used to manufacture multiple batches of your  (b)(4)  Patch over-the-counter (OTC) drug product. Several batches of OTC drug product made from these OOS API lots also had OOS results for  (b)(4)  assay. In addition, your API supplier informed you of the potential for  (b)(4)  to separate and have changes in viscosity. The supplier recommended performing additional processing steps before use in manufacturing... 3.    Your firm failed to ensure that laboratory records included complete data derived from all t

LE CLOUD ACT AMÉRICAIN NE PERMET PAS D’ESPIONNER LES ENTREPRISES EUROPÉENNES Juridique   Les éditoriaux des acteurs du Cloud   - Winston Maxwell, Associé chez Hogan Lovells En menaçant de sanctionner les entreprises européennes qui investissent en Iran, l’administration américaine renoue avec une vieille tradition d’extraterritorialité en matière de sanctions économiques. Certains font un lien avec le CLOUD Act, qui depuis le 23 mars 2018 permet aux autorités judiciaires d’ordonner la communication de données même si celles-ci sont stockées à l’étranger.  Le CLOUD Act facilite-t-il l’espionnage économique? Absolument pas. Beaucoup de fausses informations circulent à propos de cette loi récemment adoptée aux Etats-Unis. A commencer par son nom :  CLOUD  ne désigne pas ici “l’informatique en nuage”, mais est un acronyme pour  Clarifying Lawful Overseas Use of Data Act .... Plus d'information ici