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Audit, Formation et Accompagnement de vos projets réglementés

lundi 9 décembre 2019

L'A3P soumet à la FDA une proposition d’allègement de la documentation de validation des systèmes informatisés

Dans un courrier adressé le 3 décembre dernier à l'US FDA, A3P représenté par Ken Shitamoto, Senior Director, IT Quality Engineering chez GILEAD SCIENCES, soumet avec d'autres industriels une proposition d'allègement de la documentation de validation des logiciels utilisés dans la production et le contrôle des dispositifs médicaux en conformité avec la guidance The General Principles of Software Validation; Final Guidance for Industry and FDA Staff.

Cette proposition est le résultat des nombreux échanges entre les industriels et les représentants de la US FDA sur ce sujet.

Nous vous tiendrons informés des évolutions possibles sur ce sujet.

La lettre adressée à l'US FDA est disponible ici .

Making Data Work: Leveraging Data for Better Outcomes



Data collection has been a common practice for years in the pharmaceutical industry. But with the explosion of devices and technologies to acquire data, there has been an equally large explosion in the amount of data collected. Now that you have all this data what do you do with it? How do you make it work for you?

What is Big Data? What is Pharma 4.0? What is the difference between a Data Lake and a Data Cloud? But, perhaps most importantly – how do you leverage this data to make better informed decisions?

In this video documentary we will explore how new technologies and strategies are using data to achieve better outcomes. We will look at the role data plays in research and development, clinical trials, scale-up and manufacturing, and supply chain logistics.

Publié dans American Pharmaceutical review ici

samedi 30 novembre 2019

Artificial Intelligence and Machine Learning in Software as a Medical Device

Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care. The FDA is considering a total product lifecycle-based regulatory framework for these technologies that would allow for modifications to be made from real-world learning and adaptation, while still ensuring that the safety and effectiveness of the software as a medical device is maintained.

Plus d'information ici.

jeudi 28 novembre 2019

Signatures–What’s in a Name?

It is good industry practice to clarify the precise remit for each of the reviewers of a controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
Nov 02, 2019

Volume 43, Issue 11, pg 59
Q. In a recent audit, we were asked about the meaning of the signatures on our controlled documents. Our reply was that it clearly states that the signatories are either authors, reviewers, or approvers. The auditor considered our response insufficient, pointing out that we often have up to 10 reviewers. Though the names and titles of these are given, their review responsibilities are not defined or described. We are unclear how to make the meaning of the signatures more precise.
A. The regulations do not provide much detail with regards to your question. For example, the European Union guidelines (1) require, “Documents containing instructions should be approved, signed, and dated by appropriate and authorised persons.” The US regulations are a little bit more specific in 21 Code of Federal Regulations (CFR) Part 11 (2) regarding the signing of electronic records and state, “This information must include the printed name of the signer, the date and time when the signature was executed, and the meaning [emphasis added] (such as review, approval, responsibility, and authorship) associated with the signature.”
Plus d'information ici 

lundi 25 novembre 2019

Migration dans le Cloud et Data Integrity

Le “cloud computing” est depuis plusieurs années l’objet d’un intérêt grandissant de l’ensemble des secteurs économiques et notamment des industriels réglementés (pharmaceutiques, dispositifs médicaux…). 

Si les intérêts économiques d’une telle architecture sont mis en avant par les principaux acteurs du marché (Amazon Web Services, Microsoft Azure, Google…), les industriels de la santé doivent s’interroger sur l’impact d’un tel changement d’infrastructure matérielle et logicielle sur leurs applications réglementées : quid de la localisation des données, de l’«opacité » présumée de la gestion des changements, de la confidentialité des données hébergées…

Cet article a pour objet de présenter ce nouveau paradigme de fourniture de services applicatifs avec un exemple de migration d’infrastructure dans un environnement “cloud” à l’échelle d’une société internationale tout en préservant la qualité et l’intégrité des données réglementées.  

Plus d'information ici.  

dimanche 24 novembre 2019

People: The Most Persistent Risk To Data Integrity

By Kip Wolf, Tunnell Consulting, @KipWolf
Crowd-People-iStock-1065178846
In modern times, the business operating model is commonly referred to by the three resources of “people, process, and technology.” Business intelligence (BI) activities also frequently refer to the triangulation of “people, process, and technology.” And the triad of “people, process, and technology” is touted by organization change management (CM) pundits and business process management (BPM) experts alike. It is said that these maxims stem from an article by Harold J. Leavitt, Applied organisational change in industry: Structural, technological and humanistic approaches, that first appeared individually and in textbooks in the mid-1960s. And these concepts were clearly incorporated into countless titles over the decades since, including many recent books.
Plus d'information ici.

jeudi 21 novembre 2019

The Right Pieces for a Quality Program

An effective quality control unit is independent from manufacturing and ensures current standards are followed.

Nov 02, 2019
Volume 43, Issue 11, pg 16–20
The safety and efficacy of pharmaceutical products is of utmost importance. Regulations in the United States require that pharmaceutical companies establish a quality control unit to perform quality functions to ensure their products meet specifications and are safe for use. This unit also has the task of assuring regulators that good manufacturing practices (GMPs) are being followed. Regulators in Europe and other parts of the world have similar but varied requirements...


Plus d'information ici

lundi 18 novembre 2019

Cloud-based data systems in drug regulation: an industry perspective

I often say that digital technology has the potential to unlock “magic” in the biopharma industry, to the direct benefit of patients. Sometimes, the magic is not where you would first expect it to be. Take for example the use of cloud-based data systems in drug regulation. The future use of such systems will obviously require new technical capabilities and standards, but it will also require a cultural shift and a renewed partnership between the industry and regulators. One thing is certain: drug regulation in the cloud could enhance and accelerate regulatory decision-making, and that’s good news for patients. So, let’s team up and make this vision a reality. Take a look at this interesting article on the topic published this week in Nature Research (Publishing) review: https://lnkd.in/dCJabKH with Sanofi contributors Hilary M Malone PhD and Andrew Robertson hashtagdigital hashtagcloud

Plus d'information ici

Revisited - Data Integrity for Analytical Instruments connected to a LIMS via a Middleware

An interesting article published in the ECA's GMP News on November 13, 2019, https://www.gmp-compliance.org/gmp-news/data-integrity-for-analytical-instruments-connected-to-a-lims-via-a-middleware

The objective of the article published in ECA's GMP News is to explain how to manage data integrity to analytical devices connected to a LIMS via middleware.

The inquiry originating this article is: "The first data (raw data) is generated internally, processed in the middleware and sent to the LIMS. However, the manufacturer does not allow access to the original data in the automated analyser."

The objective of this article is to provide the authors' point of view to the advice provided in the ECA's GMP News article using as an example a typical manufacturing architecture.

Plus d'information ici.

Orlando Lopez

Orlando Lopez

E-Compliance and E-Records Integrity SME

mercredi 13 novembre 2019

WARNING LETTER Swabplus, L.P. MARCS-CMS 584803 — OCTOBER 31, 2019

4. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).
Your firm failed to have adequate controls in place for your High-Performance Liquid Chromatography (HPLC) and Fourier Transform Infrared Spectrometer (FTIR) systems. For example, you did not establish unique user names for each analyst. Additionally, you did not properly maintain backup copies of your original data from your laboratory equipment.
In your response, you stated that your systems were “legacy equipment” incapable of an appropriate backup. Your response is inadequate because your firm lacked a comprehensive assessment and retrospective review of all data generated from all computerized laboratory systems used in CGMP operations...
Plus d'information ici

Batch Release without Determination of Identity and Strength and other GMP violations - A Look at FDA's Warning Letters over the Last Months

When analysing the Warning Letters sent to manufacturers of finished medicinal products worldwide in the last fiscal year (from October 2018 to September 2019), it is first of all the sheer amount that surprises: with a total of 81 Warning Letters, this is the highest number over a five-year period (the Warning Letters addressed to Compounders or Compounding Pharmacies are not included in this analysis). In contrast, the number of Warning Letters to API manufacturers has fallen to the level of 5 years before after a peak value in fiscal year 2017.
Plus d'information ici

jeudi 7 novembre 2019

WARNING LETTER Bingbing Pharmaceutical Co., Ltd MARCS-CMS 584327 — OCTOBER 03, 2019

1.    Your firm failed to maintain written production, control, or distribution records specifically associated with a batch of a drug product for at least one year after the expiration date of the batch (21 CFR 211.180(a)).
You manufactured drugs at your Wuhan facility at Building (b)(4), No. 5, Kangda Street, Longyang Avenue, Hanyang District, Wuhan, and then transferred drug production to your Hubei facility and closed the Wuhan facility. Your firm failed to maintain manufacturing records, raw material and finished product testing records, retain samples, stability samples, and other CGMP records for your over-the-counter (OTC) (b)(4) drug products manufactured at your Wuhan facility. During the inspection at the Hubei facility, you stated that you lost CGMP manufacturing documentation and drug product samples during the transfer of your manufacturing facility from Wuhan to Hubei in May 2018...
4.    Your firm failed to maintain an adequate written record of each complaint (21 CFR 211.198(b)).
You firm failed to maintain a complete and accurate record of your complaint investigations. You opened investigations B-18002 and B-19001 in response to complaints of poor (b)(4) for batches manufactured in Wuhan. In these investigations you stated that you evaluated reserve samples and found no deficiencies. However, you had previously stated that all reserve samples were lost for batches manufactured at your Wuhan site and therefore reserve samples were not available for evaluation...
Data Integrity Remediation
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119570/download.
We strongly recommend that you retain a qualified consultant to assist in your remediation...
Plus d'information ici

mardi 5 novembre 2019

Poste d'Assureur Qualité Systèmes informatisés

Une société pharmaceutique recherche pour son site en région parisienne un Assureur Qualité Systèmes informatisés.

Mission : Garantir la conformité des e-systèmes des processus qualité/système documentaire aux exigences réglementaires, et assurer leur amélioration.

Activité principale et tâches :

  • Gérer l’administration fonctionnelle de routine de la GED et des systèmes QMS sous sa responsabilité
  • Projet - Améliorer les flux des processus qualité, le système documentaire
  • Référent Data integrity et compliance des systèmes informatisés
  • S’assurer du respect des Bonnes Pratiques de Fabrication (BPF)
Si vous êtes intéressés, contactez-nous ici.