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Toward the end of July, the FDA issued a draft Q&A guidance specifying how manufacturers should report postapproval manufacturing changes for licensed biosimilar and interchangeable products. Read the full guidance: https://lnkd.in/geDJqBEm At a glance: ▪ The Q&A addresses the different postapproval reporting categories. The FDA differentiates post-approval changes into three categories: major changes requiring the filing of a prior approval supplement (PAS); moderate changes requiring the filing of a change being effected-30 days supplement (CBE-30); and minor changes requiring only the filing of an annual report. ▪ The guidance also discusses the type of reference materials applicants should submit to compare pre- and post-change material. Manufacturers should use “well-qualified, in-house reference material” comparability studies to evaluate the effect of the change on biosimilar or interchangeable biosimilars. ▪ The FDA also discusses how to introduce a biosimilar and interchangeable product into a multiproduct manufacturing area or a multiproduct contract manufacturing facility. "Risks associated with introducing a licensed biosimilar or a licensed interchangeable biosimilar into a multiproduct manufacturing area or a multiproduct contract manufacturing facility depend on the type of product being introduced and the potential addition of further control measures to ensure that the product meets its intended quality characteristics, including purity. Identity testing is one tool used to detect and control such risks.” FDA advises sponsors to consult three guidances on reporting manufacturing changes for these products. These include: 📃 The 1997 guidance, Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products 📃 The December 2021 guidance, CMC Postapproval Manufacturing Changes for Specified Biological Products to be Documented in Annual Reports 📃 The June 2021 guidance, Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products ——— 🔒 Paid subscribers to our Insider Newsletter get our full guidance breakdown and recommendations: https://lnkd.in/gU45agMs #fda #biosimilars #biosimilar

When in the world of pharmaceuticals, packaging integrity is paramount. Because even the slightest ❌ deviation can have far-reaching consequences. That's why companies like Carclo plc are turning to cutting-edge technologies like ultrasonic sealing from ATS-Tanner for their critical packaging processes. Key benefits of ultrasonic sealing in the pharma industry: 1️⃣Unmatched Precision: Delivers accurate, reproducible welds time after time, ensuring product safety and consistency. 2️⃣ Material Compatibility: Works with specialized films like FTN, designed to meet stringent pharmaceutical hygiene and quality standards. 3️⃣ Process Reliability: Minimizes downtime and maximizes throughput in highly-controlled sterile environments. 4️⃣Automation Friendly: Facilitates seamless robotic integration for predictable operations and optimized production. Are you too exploring ways to elevate your pharmaceutical packaging precision? Learn more about the advantages of ultrasonic sealing for pharmaceutical packaging. Visit ATS-Tanner: https://lnkd.in/d4wb94f 👉 Could ultrasonic sealing be the key to optimizing your process in ways you haven't considered? 🗓️ Visit us in EMPACK PORTO 17-18th of April #pharma #healthtech #packaging#business #technology #innovation #work #pharmaceuticals #healthcare #biotech #pharmacy #manufacturing #supplychain #design

#PRE -FORMULATION Pre-formulation studies are conducted in pharmaceutical development before the formulation of a drug product begins. Their main objective is to gather essential information about the physical, chemical, and mechanical properties of the active pharmaceutical ingredient (API) and its compatibility with excipients. The goals of pre-formulation studies include: Characterization of API: This involves determining the chemical structure, purity, solubility, stability (under various conditions such as temperature, humidity, pH), and particle size of the API. Physicochemical Properties Evaluation: Understanding properties like melting point, polymorphism, crystallinity, and hygroscopicity of the API helps in selecting suitable formulation approaches. Compatibility Studies: Assessing the compatibility of the API with different excipients (e.g., binders, disintegrants, lubricants) and packaging materials is crucial to avoid any interactions that could affect the drug's efficacy or stability. Formulation Development Guidance: Pre-formulation studies provide insights into potential formulation strategies, such as whether the drug should be formulated as a tablet, capsule, solution, suspension, or another dosage form, and which excipients may be suitable for enhancing stability and bioavailability. Optimization of Formulation Process: By understanding the physicochemical properties of the API and its interactions with excipients, pre-formulation studies help in optimizing the formulation process to ensure consistent product quality and manufacturability. Overall, pre-formulation studies play a vital role in laying the groundwork for successful formulation development by providing essential data and guiding formulation decisions. #pharma #pharmaceutics #pharmacist

In the fast-paced world of pharmaceutical and biotech manufacturing, minimizing contamination and enhancing efficiency are paramount. The latest Chemtech article delves into the critical role of high-quality plastic vial trays in achieving these goals. Crafted with precision, adhering to FDA standards, and designed for durability, these trays streamline the manufacturing process, from filling to storage, ensuring safety and reducing the risk of costly recalls. Discover how our innovative vial tray solutions, equipped with functional accessories like lids and dividers, are setting new standards in operational excellence and compliance. Embrace the future of pharmaceutical manufacturing with us and learn why choosing the right supplier matters in safeguarding product integrity and optimizing production lines. #PharmaceuticalManufacturing #BiotechInnovation #FDACompliance #QualityAssurance #OperationalExcellence #PharmaSupplyChain #ManufacturingEfficiency

FDA Issues Guidance on Manufacturing Changes to Biosimilars and Interchangeable Biosimilars     Today, FDA issued a draft guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products. This guidance provides biologic product manufacturers with recommendations on the nature and type of information they should provide FDA to support postapproval manufacturing changes to licensed (approved) biosimilar and interchangeable biosimilar products. FDA previously provided recommendations for postapproval manufacturing changes to biosimilars as part of a September 2021 final guidance. The agency did not include recommendations for postapproval manufacturing changes to interchangeable biosimilars at that time. The agency has since determined the principles that apply to postapproval manufacturing changes to licensed biosimilar products are also relevant to licensed interchangeable biosimilar products and today’s guidance provides recommendations for both. FDA is publishing this draft guidance to fulfill a commitment made in the 2022 reauthorization of the Biosimilar User Fee Act. Comments regarding the draft guidance should be submitted following the information in the notice of availability that will be posted in the Federal Register shortly. #fda #guidance #biosimilar #interchangeable #manufacturing #postapproval #changes https://lnkd.in/g3w8mUXy

Powder Packaging Machine ( With Servo Auger Filler ) A powder packaging machine with a micro servo auger filler is a precision system for packing powdered substances. It utilizes servo-driven technology for accuracy, equipped with a hopper, auger screw, and packaging unit. The machine ensures consistency, high-speed operation, and minimal wastage, making it ideal for pharmaceuticals, food, and chemical industries. #PowderPackaging #MicroServoAugerFiller #SachetPacking #PrecisionPackaging #Automation #IndustrialPackaging #Efficiency #ProductConsistency #Pharmaceuticals #FoodIndustry #ChemicalManufacturing

While in the early development stage of packaging, the supplier is obliged to ensure that the packaging is by design capable of ensuring sterility. Therefore, the packaging must to be tested for defects in the range of 0.2 µm, respectively 6 * 10-6 mbar*l/s („maximum allowable leak level“; MALL). Based on a study from Kirsh, this is the defect size where the microbial ingress failure rate is 0 %. Integrity tests are mainly performed in the range of 2 to 20 µm defect size. The main reason for this is the feasibility of the available methods to detect smaller defects in a reasonable test time. When dealing with 100 % inspection of the production line that operates at speeds for 120 to 600 parts per minute, the allowed defect size is sometimes even increased to a significantly higher level. To compensate on the risk-based approach, additional off-line sample testing is performed to a tighter specification in the range of 1 to 10 µm. This also applies to stability testing which is performed in laboratory tests. Here again the sensitivity is more important than the test time. #leakdetection #leaktesting #ccit #pharmapackaging #drugmanufacturing Source: Pharmaceutical Online, Pfeiffer Vacuum, Pfeiffer Vacuum, Inc.

Quality in Pharmaceuticals production is not achieved by accident,it is a result of deliberate actions taken to keep the manufacturing process under control. From the input of raw materials to the release of the finished product (FPP),the manufacturing process should remain robust with no significant inter- and intra-batch variability. During manufacturing,the critical stages identified to be of high risk require optimal control by conducting routine in-process checks(IPC) and adequate monitoring. If left unchecked,the manufacturing process may yield products which are substandard and out of specifications (OOS). Such products can significantly increase the cost of production as they require re-processing. In some cases,OSS products are recalled from the market due to failed product performance and non conformance to quality, safety and efficacy standards.In order to achieve consistency in the quality of the products,the critical process parameters for the manufacturing process and the critical quality attributes of the product should be identified and validated for each and every dosage form. #Qualitybydesign.

Airlocks and its Purpose and applications Airlocks are commonly used in the pharmaceutical industry to maintain cleanliness and prevent contamination of the manufacturing environment. In a pharmaceutical manufacturing facility, an airlock is a small, enclosed space that is used to transition between clean and lees clean areas. It typically consists of two or more doors that can be opened and closed to allow personnel or material to pass through while maintaining a separation between the two areas. the purpose of an airlock in a pharmaceutical facility is to prevent contaminants from entering the clean areas, where drugs are manufactured and packaged. It also helps to prevent the spread of contaminants from one area to another within the manufacturing facility Working operation of airlocks in pharmaceutical manufacturing facilities Airlocks are often equipped with features such as air showers, which use high-pressure jets of air to remove dust and other particles from clothing and equipment before entering the clean area. They may also include HEPA (high-efficiency particulate air) filters, which remove particles from the air to maintain a sterile environment. In addition to airlocks, pharmaceutical facilities may also use other types of barriers and controls, such as gowning rooms and negative pressure rooms, to maintain the cleanliness and safety of their manufacturing environments. #pharmaceutical #sterial_products #Aseptic_area #cleanroom

A cleanroom is a room in which viable & non viable particle count, temperature, humidity & differential pressure is maintained within standard and defined ranges. 👉Cleaning is a strict requirement for cleanrooms and it is necessary to maintain their defined cleaning level all the time.Cleanrooms play a critical role in the manufacturing of pharmaceutical products. 👉Cleanroom classification in pharmaceutical industries is based on the size of particles and the number of particles per cubic meter of air. There are specified limits of particle count,microbial counts and air changes for the cleanrooms. 👉Classification Of Cleanrooms In Pharma Clean rooms are classified according to following standards, 👉ISO 14644-1 👉Federal Standards (FS 209) 👉European Standards According to ISO 14644-1 Classification of cleanrooms ap per ISO 14644-1 is as follows 👉ISO 1 👉ISO 2 👉ISO 3 👉ISO 4 👉ISO 5 👉ISO 6 👉ISO 7 👉ISO 8 👉ISO 9 In ISO there are 9 cleanroom classes, ISO 1 to IOS 9.ISO 1 is the cleanest from all classes of ISO and ISO 9 is least clean or dirtiest in all ISO classes but cleaning level of ISO 9 is superior than a regular room. In pharmaceutical Industries following ISO, classes are generally required 👉ISO 5 👉ISO 6 👉ISO 7 👉ISO 8 According to FS 209 According to the federal standard, FS 209 Cleanrooms are classified as, 👉Class100 👉Class1000 👉Class 10,000 👉Class100,000 According To The EU GMP 👉Grade A 👉Grade B 👉Grade C 👉Grade D 👉FS 209 is replaced by ISO 14644-1 but these terms are still in use. In ISO particle are taken as particles/m³ (cubic meter)and in FS 209 particles were taken as particles/ft³(cubic feet) 👉A simple comparison of cleanrooms classification for pharmaceutical industries is as follow... Read complete article in the following https://lnkd.in/e_M-C_73