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Articles by Harmik Sohi
02.21.25 -- FDA Finalizes Guidance On The Advanced Manufacturing Technologies Designation Program
Following its popular inaugural 2024 Bio-Expo Live, Bioprocess Online brings you the next opportunity to advance your drug development agenda. Over just a small portion of your week and from the comfort of your computer, discover the latest solutions in upstream and downstream bioprocessing as well as bioprocess quality, data, and analytics. 15-minute presentations from leading suppliers will give you just the right insight to make your next best move in drug development. Register here.
11.27.24 -- More AI But Fewer Process Chemists?
Webinar: Removing the Headache: Outsourced Stability Storage and Testing Solutions Pharmaceutical and biotech companies must decide whether to outsource stability storage and testing or handle them in-house. Outsourcing offers cost savings, risk reduction, and compliance benefits.
07.19.24 -- Why Knowledge Workers Must Embrace Standard Work
An Overview Of Contamination Control Strategy (CCS) Join experts Londa Ritchey and Patrick Nieuwenhuizen as they explore the key role of a contamination control strategy in Annex 1 for ensuring patient safety and continuous manufacturing improvement.
07.12.24 -- What's In Your DMF?
Not really into choosing extended time away and exhibit halls over the simple pleasures of summertime? No reason to put your CDMO search on hold – Outsourced Pharma Capacity Update’s PARTNER WEEK is here! Take the travel and headache out of your plans and join us right from your computer. Assess potential fit for your next drug development project in convenient 20-minute segments – all grouped by molecule type. Presenters will share current available capacity across featured capabilities.
Project Management: The Secret Weapon In Effective Tech Transfer
By Harmik Sohi, Director – Injectables and Specialty Formulations, Jubilant HollisterStier Tech transfer can seem like a strategic puzzle due to the complex nature of disseminating knowledge, experience, documents, and processes between the client company and the contract manufacturer. A skilled project manager and management team are needed to help navigate this complex sharing of information to ensure every need is accounted for.
10.17.22 -- FDA User Fee Programs Reauthorized: CBER The Clear Winner
By Louis Garguilo, chief editor, Outsourced Pharma If you are a drug sponsor or manufacturer (or soon to be) you may benefit from an online, direct-to-patient (DTP) strategy. “Selling DTP allows for larger margins and bigger markets. You don't have to pay all the middle people to get your product out there. It’s a great proposition. You gain more control.”
09.13.22 -- Replacing The MAC/MACO With The MSC: Rethinking How Cleaning Validation Limits Are Calculated
By Andrew Walsh, Thomas Altmann, et al. Two of the most commonly used terms in pharmaceutical cleaning validation are the maximum allowable carryover (MAC or MACO) and the maximum safe carryover (MSC). This article provides the historical development of both terms and why we should replace the MAC/MACO with the MSC.
06.28.22 -- FDA Updates Guidance For Investigating OOS Test Results for Pharma Production
By Mark Durivage, Quality Systems Compliance LLC FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.
04.21.22 -- Best Practices Working With CDMOs
Newsletter | April 21, 2022 By Pharmaceutical Online In pharmaceuticals, working effectively with contract development and manufacturing organizations (CDMOs) is an art as well as a science. This e-book gives advice to established as well as emerging pharma companies on working with your CDMO on topics such as CMC support, quality assurance, risk assessment, and shared qualification audits, and it also provides tips to facilitate trust and to further the relationship.
Selecting A CMO Partner For Sterile Injectable Manufacturing
By Harmik Sohi, Director – Injectables and Specialty Formulations, Jubilant Pharma For many drug developers and manufacturing sites, performing the transfer of a product or technology from a small-scale development process (or R&D process) to full-scale commercial manufacturing can prove challenging. Finding the right contract manufacturing organization (CMO) partner to help navigate this scale-up can greatly simplify the process.
Selecting A CMO Partner For Sterile Injectable Manufacturing
By Harmik Sohi, Director – Injectables and Specialty Formulations, Jubilant Pharma For many drug developers and manufacturing sites, performing the transfer of a product or technology from a small-scale development process (or R&D process) to full-scale commercial manufacturing can prove challenging. Finding the right contract manufacturing organization (CMO) partner to help navigate this scale-up can greatly simplify the process.
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