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

1. Failure to prepare and use production and control records for each intermediate and API batch. Your site produces crude heparin for purification into finished API. During a pre-inspectional call on July 10, 2019, your firm stated to FDA that you had not manufactured any materials for months. At the start of the FDA inspection on July 31, 2019, your firm stated to the investigator that you were not manufacturing crude heparin and were only per forming equipment testing. During a walkthrough of your warehouse, the investigator observed a warehouse employee leaving the warehouse with a fiber drum and inquired about the contents of the drum. Your firm stated that the drum contained  (b)(4)  bags. However. inspection of the drum revealed two batches of crude heparin manufactured just a few days before the FDA inspection (CU190726,  (b)(4) , manufacturing date July 26, 2019, and CU 190727,  (b)(4) , manufacturing date July 27, 2019). When asked about manufa...

1. Your firm failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(2)). You lacked adequate testing of the incoming  (b)(4)  active pharmaceutical ingredient (API) to determine assay and other appropriate quality attributes. Instead, your firm relied on your suppliers' certificates of analyses (COA) without establishing the reliability of the suppliers' analyses through appropriate validation . You must test each component for conformity with appropriate written specifications for purity, strength, and quality unless and until you have appropriately qualified the suppliers and validated their test results at appropriate intervals... 2. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)). Your firm lacked appropriate validation (or verification, for United States Pharmacopeia (USP) compendial...

by  Gareth Macdonald Thursday, February 20, 2020  6:41 am An effective quality management system is a must for biopharmaceutical firms looking to protect their data assets against hackers according to a leading cybersecurity expert. Increasingly biopharmaceutical manufacturing relies on data. Ensuring optimal conditions are maintained in bioreactors or that chromatography systems are functioning properly depends on monitoring systems that feed information back to control systems. Image: iStock/stevanovicigor Likewise, data is key to how biopharmaceutical products are tracked through packaging and distribution systems to ensure they get to the correct hospital, pharmacy or – in the case of personalized medicine – patient. But while these systems may make manufacturing more efficient and improve product quality, they are also a potential vulnerability. Link to article - CLICK HERE

Data management is crucial in bio/pharmaceutical laboratory settings from discovery steps through clinical studies and varies based on the development phase. Feb 01, 2020 By  Lauren Lavelle BioPharm International Volume 33, Issue 2, pg 35-36 Link to article - CLICK HERE In nonclinical settings, good laboratory practices (GLPs) ensure the quality of the studies conducted, including the integrity of the data collected. Features needed for compliant data management include detailed final study reports, the proper storing of all raw data, documentation, and protocols, and a responsible archivist to maintain responsibility for the stored data (1).

How democratization of data is powering a new wave of opportunities Key Challenges Today’s clinical research environment is more competitively challenging, has higher costs and takes longer to bring a drug to market than at any other time in history. According to the 2015 Tufts Center for the Study of Drug Development research, from 2005-2015 the average Phase III study saw an increase in the complexity of protocols, driven by the ever-increasing set of inclusion and exclusion criteria (+61%), number of clinical endpoints (+25%), and number of study visits (+25%) and procedures (+70%), are driving more and more protocol amendments and adding to that cost and time. At the same time, the percentage of patients taking part in clinical studies remains at historically low rates, estimated to be less than five percent of the patient population. This contributes to low and non-enrolling sites, further contributing to the cost and time. One of the common threads across all these challe...