Abstract

QUALITY ASSURANCE IN TABLET FORMATION

Asst. Prof. Ranjit Madhukar Shelake*, Sagar Anil Godse, Pooja Tanaji Itape, Nikita Sanjay Musale, Omkar Chandrakant Kadam, Omkar Madhukar Fule, Pooja Ram Bangar, Prajakta Kamalakar Didwal and Pratiksha Sudhir Doke

.

Abstract

This project outlines a comprehensive quality assurance framework for tablet and capsule manufacturing, focusing on the critical aspects of raw material scrutiny, vendor qualification, and approval processes. Rigorous testing, thorough inspections, and meticulous documentation are emphasized to ensure the safety and efficacy of pharmaceutical products.For raw materials, a structured approach is proposed, involving specification establishment, vendor qualification, incoming material inspection, sampling and testing, documentation review, risk assessment, approval decisions, traceability, record-keeping, and continuous monitoring. These processes aim to maintain consistency, integrity, and compliance throughout the manufacturing stagIn parallel, the quality assurance of packaging materials is addressed, covering specification definition, vendor qualification, incoming material inspection, print quality and information verification, barrier properties testing, compatibility testing, seal integrity, regulatory compliance, documentation review, traceability, and record-keeping. These measures are vital to guarantee the integrity, safety, and compliance of the final product. The project extends its focus to the entire manufacturing process, detailing the updates required in Batch Manufacturing Records (BMR), Master Formula Records (MFR), and Batch Packaging Records. Thorough documentation of batch details, raw materials, processing steps, in-process testing, environmental conditions, packaging details, and quality control checks is essential to maintain product quality and compliance.A Standard Operating Procedure (SOP) for quality assurance in tablet manufacturing is presented, encompassing clear objectives, scope, responsibilities, document control, definitions, materials and equipment specifications, procedures, batch record review, training, documentation and record-keeping practices, audits and inspections, corrective and preventive actions (CAPA), change control, review and approval processes, references, attachments, distribution, and a detailed review process. Equipment qualification, including design, installation, operational, and performance aspects, is crucial for ensuring that manufacturing equipment meets specified requirements and regulatory standards. The project provides guidelines for documentation, regulatory compliance, Validation Master Plan (VMP), change control, and requalification.Specific focus is given to the qualification of the compression machine, with parameters such as compression force, tablet weight, and hardness under scrutiny. Calibration processes for various machines involved in tablet manufacturing, including B.T machine, hardness tester, friabilator, leak test apparatus, and dissolution test apparatus, are outlined to ensure precision and compliance. Additionally, processes such as punching, polishing, and tray dryer qualification with temperature mapping are discussed, emphasizing the importance of accurate tablet formation, surface finishing, and consistent drying conditions. The coating machine's role in tablet manufacturing is highlighted, addressing uniform coating thickness, defect inspection, and adherence to predetermined standards. The qualification of the Air Handling Unit (AHU) is crucial for maintaining controlled and clean air environments, involving performance verification and regulatory compliance.

Keywords: .