by Dr. Yashashwini Reddy | Sep 2, 2025
🔹 Tablet Manufacturing Process: An Overview Tablets are solid dosage forms containing one or more active pharmaceutical ingredients (APIs) with suitable excipients. The manufacturing process must ensure uniformity, stability, safety, and efficacy. 1. Pre-Formulation...
by Dr. Yashashwini Reddy | Sep 2, 2025
🔹 1. Process Optimization Lean Manufacturing (Lean Pharma): Eliminate non-value-added steps, reduce waiting times, optimize material flow. Six Sigma & QbD (Quality by Design): Use statistical tools (DoE, risk assessment) to identify Critical Process Parameters...
by Dr. Yashashwini Reddy | Sep 1, 2025
🌡️ Different Types of Temperature Sensors 1. Thermocouples Principle: Seebeck effect (voltage generated at junction of two dissimilar metals). Range: –200 °C to +1800 °C (depending on type: J, K, T, R, S). Pros: Wide range, rugged, fast response. Cons: Lower accuracy...
by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To establish a standard procedure for monitoring non-viable airborne particulate matter in controlled manufacturing areas to ensure compliance with ISO 14644, EU GMP Annex 1, and regulatory requirements for sterile manufacturing. 2. Scope This SOP applies...
by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To describe the procedure for monitoring microbiological contamination in controlled areas using the settle plate (passive air sampling) method. 2. Scope This SOP is applicable to all classified areas (Grade A/B/C/D) in manufacturing and microbiology...
