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Audit, Formation et Accompagnement de vos projets réglementés

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.

jeudi 31 octobre 2019

MHRA : Digital Health and Pharma 4.0

Posted by:

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

mercredi 30 octobre 2019

WARNING LETTER Deb USA Inc. MARCS-CMS 570944 — JUNE 11, 2019

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 laboratory control mechanisms (21 CFR 211.160(a)).
Laboratory personnel failed to follow written procedures for testing components and drug products. For example:
A. Your personnel failed to follow your procedure for enumeration of viable microorganisms. Your procedure requires (b)(4) and (b)(4) in (b)(4) on both (b)(4) and (b)(4). Your firm’s practice is to prepare (b)(4) on a (b)(4) plate and a (b)(4) plate for incubation.
B. Your procedure for enumeration of viable microorganisms required (b)(4) to be tested per (b)(4). However, your firm tested (b)(4) samples on the same (b)(4). In your response, you acknowledged testing (b)(4) samples on the same (b)(4).

C.
Many microbiological testing activities were not contemporaneously documented. Significantly, our investigators found microbiological test plates in a laboratory trash can with no written record of their receipt, preparation, incubation, or reading. The test sheets for the undocumented plates were not completed and the employee stated he would record the results later from memory...
4. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
Our inspection found instances in which your firm overwrote electronic testing data, discarded original testing records, and failed to report OOS laboratory test results. For example:

A. Your HPLC software configuration allows users to overwrite data resulting in original data being irretrievable. A torn-up HPLC chromatogram was discovered in a dumpster outside your facility on October 23, 2018. The chromatogram was for a stability testing assay result for Refresh PureBac Foam, lot 044262. The electronic file and method were manipulated yielding different results. The data manipulation was not captured in the audit trail and the passing result from a single injection was reported on the “OTC Stability Testing Results” form.
B. The OOS result from HPLC assay testing of Brady Clear, lot 8072, was not reported. Two injections of the sample were performed and yielded results of 0.516808% and 0.495222%. Your procedure requires the results to be averaged (specification of (b)(4)). However, rather than reporting the average assay result, which failed, you reported the initial single injection result that was (b)(4) to meet the specification (b)(4).
Plus d'information ici 

BIOCORP accélère ses innovations avec le lancement de sa seringue connectée Injay

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 

EMA: Updated and revised Q&A on MDR and IVDR



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.

Jumeaux numériques : Dassault Systèmes renforce son pôle santé avec l'acquisition de Medidata

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 ?

Jumeaux numériques : Dassault Systèmes renforce son pôle santé avec l'acquisition de Medidata
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

mardi 29 octobre 2019

L'OMS appelle aux commentaires sur sa ligne directrice "Data Integrity"

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.

samedi 26 octobre 2019

Le Pentagone signe un contrat de 10 milliards de dollars avec Microsoft

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)

  • Plus d'information ici

jeudi 24 octobre 2019

ALCOA+ and Data Integrity


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
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 

mardi 22 octobre 2019

Sanofi opens new Framingham site amid $1.6B bet on bio-manufacturing

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