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Manufacturing Process at Talwar Pharma
Manufacturing in the pharmaceutical industry is not just about production; it is about precision, consistency, and commitment to patient safety. Talwar Pharma, a GMP-certified organization based in Roorkee, Uttarakhand, has been at the forefront of manufacturing bulk drugs (pellets) and finished dosage forms like tablets and capsules since 2007. The company’s dedication to high-quality production is evident in its use of advanced technology, robust infrastructure, and skilled workforce. This blog explores the comprehensive manufacturing process followed at Talwar Pharma, highlighting each stage from raw material procurement to final product packaging.
1. Raw Material Procurement Every great product begins with high-quality raw materials. Talwar Pharma sources APIs (Active Pharmaceutical Ingredients) and excipients from approved vendors after thorough qualification. All raw materials undergo identity testing, assay, and other quality checks in the Quality Control (QC) lab before being released for production. This ensures that the inputs used are consistent and within specified parameters.
2. Dispensing and Weighing Once approved, materials are dispensed in a controlled environment using calibrated balances. Talwar Pharma ensures precise weighing to maintain batch consistency and avoid cross-contamination. All operations are documented as per SOPs, and environmental conditions are monitored to ensure hygiene and accuracy.
3. Granulation Process Granulation helps improve the flow and compressibility of powders. Depending on the formulation, Talwar Pharma uses either wet granulation or dry granulation techniques. Equipment like Rapid Mixer Granulators (RMG) and Fluid Bed Dryers (FBD) ensure uniform granule formation. Parameters such as moisture content, particle size, and bulk density are carefully monitored.
4. Pellet Manufacturing Pellets are a significant strength of Talwar Pharma. The pelletization process involves techniques like extrusion-spheronization and layering using Fluid Bed Coaters (FBC). Drug-layered pellets are further coated with enteric or sustained-release polymers to control the drug release profile. These pellets are ideal for multi-particulate delivery systems, offering better bioavailability and patient compliance.
5. Compression and Encapsulation For tablets, the granules are compressed using high-speed rotary tablet presses. Parameters like hardness, thickness, weight variation, and disintegration time are monitored throughout the process. Capsules are filled using automatic capsule-filling machines, which ensure uniform dosing and sealing.
6. Coating and Polishing Tablet and pellet coating is done in stainless steel coating pans and fluid bed processors. Coating improves product stability, taste masking, and aesthetics. Talwar Pharma uses aqueous and non-aqueous coating solutions, depending on the formulation requirements. Capsules are polished to remove any powder traces, improving visual appeal.
7. In-Process Quality Checks In-process checks (IPQC) are conducted at every critical stage—granulation, compression, coating, and packing. Talwar Pharma’s IPQC team ensures all batches comply with standard specifications before moving to the next stage.
8. Packaging Finished products are packed in blister packs, alu-alu strips, or bottles in cleanroom environments. Primary packaging materials are sourced from certified vendors and tested for compatibility. Labels are verified against batch records to avoid errors. Packaging ensures product protection, traceability, and user convenience.
9. Final Quality Control Before release, every batch undergoes final testing in the QC lab. Tests include assay, dissolution, uniformity of content, microbial limits, and stability studies. Only batches that pass all parameters are approved by the Quality Assurance (QA) team.
10. Documentation and Batch Review Talwar Pharma maintains thorough documentation at every step. Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and analytical data are reviewed before batch release. Any deviations are documented and subjected to a CAPA (Corrective and Preventive Action) plan.
11. Environment, Health & Safety (EHS) Safety is integral to the manufacturing process. Talwar Pharma follows stringent EHS guidelines to ensure employee well-being and environmental protection. Waste disposal, water treatment, and energy usage are optimized to minimize the environmental footprint.
12. Continuous Improvement The manufacturing team constantly seeks ways to improve processes, reduce cycle time, and enhance efficiency without compromising quality. This includes investing in new technologies, upgrading equipment, and ongoing staff training.