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2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)). Your firm receives raw material, " (b)(4) " as a component for use in production of  (b)(4) . This raw material is a  (b)(4)  containing  (b)(4) , the active ingredient in your finished drug product. Though you receive this raw material with a certificate of analysis from your supplier, you have not performed appropriate incoming analysis of component lots upon receipt, including confirming the identity prior to use in production of your finished drug product. You also relied on your supplier's Certificate of Analysis without establishing the reliability of your component supplier's test analyses at appropriate intervals . Link to WL - CLICK HERE

1. 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)). Your firm did not maintain complete and accurate data from all laboratory testing. Without reliable laboratory data, you cannot assure appropriate decisions regarding batch release, product stability, and other drug aspects of quality. For example: a. On May 19, 2018, the peak detection function was disabled multiple time s during the gas chromatography (GC) residual solvent testing of your incoming active pharmaceutical ingredient (API),  (b)(4)  batch  (b)(4) . After reviewing the chromatograms, our investigators noted unknown peaks that were not reported or integrated as required per your procedure. Our investigators requested your firm to reprocess the sample set sequence, which subsequently showed >  (b)(4) % total unknown impurity peaks. You used this b...

Technologie :  Le département de recherche d'IBM a mis au point une nouvelle méthode de détection des cancers du sein reposant sur l'usage de l'intelligence artificielle. Une avancée majeure pour la santé publique ? Une étude récente menée par le département de recherche d'IBM a révélé comment la combinaison d'algorithmes d'apprentissage automatique et d'évaluations de radiologues pouvait améliorer la précision globale des dépistages du cancer du sein. Selon Stefan Harrer, chercheur à IBM, les mammographies, couramment utilisées par les radiologues pour la détection précoce du cancer du sein, reposent souvent sur l'expertise d'un radiologue pour identifier visuellement les signes du cancer, ce qui ne s'avère pas toujours précis. « Dans l'état actuel de l'interprétation humaine des images de mammographie, deux choses peuvent se produire : un diagnostic erroné en termes d'absence de cancer et aussi un diagnostic de cancer lorsqu...

Technologie :  Une solution de télésuivi à domicile pour les patients porteurs ou suspectés Covid-19 vient d'être lancée par l’AP-HP. Elle est déjà en production dans deux hôpitaux parisiens. Cette application de e-santé (en cours de validation sur le Google Play Store et d'ors et déjà disponible sur  le store iOS ) doit permettre le suivi médical à domicile des patients porteurs ou suspectés Covid-19 qui ne nécessitent pas d’hospitalisation assure l’AP-HP (Assistance Publique - Hôpitaux de Paris). Elle est destinée à tous ceux qui pensent être infectés par le Covid-19 "sans signe de gravité". L'objectif ? Bénéficier d’un télésuivi à domicile via des questionnaires médicaux "proposés une ou plusieurs fois par jour", et ce en complément de mesures de confinement. Via cette application , un médecin inclut le patient dans le processus (connexion à la plateforme, inscription du patient en saisissant ses données administratives et les données médicales ...

Better understanding and control of cell behavior is yielding benefits, upstream and beyond. Mar 01, 2020 By  Agnes Shanley BioPharm International Volume 33, Issue 3, pg 12-14 In the earliest days of biotech, developers often struggled to sustain conditions that would optimize cell health and product yield. Today, better understanding of cells and how they interact with their environment has enabled improvements in most aspects of upstream processing, from bioreactor design and media development to process control, automation, and modeling. Some of the most significant gains have been made in cell line expression, advanced sensors, and automation, says Atul Mohindra, R&D director for biomanufacturing at Lonza Pharma and Biotech. “Using automation, process analytical technologies (PAT), and advanced multivariate analysis has enabled the industry to control process performance and product quality more closely than ever before,” he adds. Link to article -...

Ensuring the quality of data in process monitoring and control systems starts in process development phases. Mar 01, 2020 By  Cynthia A. Challener BioPharm International Volume 33, Issue 3, pg 18–22, 38 As biopharma manufacturers incorporate more data-driven monitoring and control systems in production processes, the quality of the data, as well as integrating, interpreting, and protecting it, become more important. One solution is to build quality features into these systems during process development. As a process scales, “there is a need to transfer or integrate process development (PD) data; therefore, building data quality into these activities right from the start is important. Management of data quality always facilitates integration with other systems irrespective of the scientific or business purpose,” observes Chris Andrews, a senior solution consultant with Dassault Systèmes BIOVIA. “In the case of monitoring data during process developmen...

Current state: islands of automation In the biopharmaceutical industry (biopharma), process data is used in many ways throughout process development (PD) and the different production phases. But the pieces of equipment are often connected only by process; that is, the bioprocess material passing between each of them. Often this connection is discontinuous, meaning that equipment is controlled on an instrument level, which results in islands of automation. This article outlines how connectivity and a comprehensive automation solution can ease technology transfer and scaling from PD to final manufacturing scale. Suitable  automation solutions also help maximize both manufacturing efficiency and facility utilization . Link to article - CLICK HERE

1. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)). Your firm failed to properly integrate co-eluting peaks during impurity testing of phentermine HCL capsules, which resulted in your analysis failing to detect out-of-specification (OOS) results for at least one lot of drug product. You self-identified this problem in 2016. In a deviation report, you wrote that analysts were using “ (b)(4)  methods” and the “reported impurity levels may not reflect the true concentrations found in the drug.” Your firm conducted training on May 24, 2016, reportedly to teach analysts to properly integrate and measure closely co-eluting peaks during impurity analysis of your drugs. Despite this training, in December 2016 your analyst performed  (b)(4)  integration to calculate the area of the peaks for a stability impurity test for Lot 12456A of phentermine HCL capsules. If the appropriate...

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)). Your quality unit (QU) lacked adequate responsibilities and authorities to assure reliable operations. For example: A. You failed to ensure the audit trail feature was enabled on your Inductively Coupled Plasma - Optical Emission Spectrometry (lCP-OES) instrument to track creation, modification, or deletion of data. This instrument was used to obtain assay results for your drug products. B. You stored your master batch records as unlocked Excel files which were open to alteration, duplication, and deletion by unauthorized personnel. C. Your analysts used open Excel files for documenting sample preparation information and final calculations. These records were not retained. For example, your personnel admitted...

3. 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)). When requested, your firm could not provide test results to support the microbiological testing results on your certificate of analysis (COA) for bisacodyl and phenylephrine suppositories, yet your firm signed the COA indicating conforming results for microbiological testing and released the batche s. During the inspection, you also could not explain whether samples had been sent to your third-party lab for analysis to support the results on your COA. Your response stated that, going forward, no COA will be signed without receipt of the actual results, but did not include information about the review and management data to support release of your drug products. In response to this letter, provide: • A list of chemical and microbial test methods and specifications used to analyze ...