1.0 OBJECTIVE: Cleaning Validation Protocol for Sifter to ensure that the cleaning procedure for Sifter removes residues to the extent of compliance with pre-determined acceptance level. 2.0 SCOPE: This protocol applies to Pharmaceutical Manufacturing Facility (name of company and place) 3.0 RESPONSIBILITY: It is a joint responsibility of Quality Control, Production and Quality Assurance departments. … Read more
Tablet presses or Compression machines are mechanical devices that compress granulated powders into uniform tablets for pharmaceuticals and other solid-dosage products. These machines force material between matching upper and lower punches seated in a die cavity to fuse it into a solid form. In operation, the lower punch first lowers into the die to create … Read more
The penetration of steam into all parts of the autoclave is essential for achieving and maintaining effective sterilization. The Bowie–Dick test is performed to verify adequate air removal and uniform steam penetration within a pre-vacuum steam autoclave, using a standardized Bowie–Dick test pack. During sterilization, air pockets and non-condensable gases may remain trapped inside the … Read more
Fumigation and fogging are commonly used in pharmaceuticals to control microbial contamination in controlled areas. Fumigation is a gaseous sterilization process that kills microorganisms and prevents microbial growth in the air or on surfaces such as walls and floors. Fumigation agents, such as formaldehyde and potassium permanganate, are often used to control microorganisms. This technique … Read more
Water is widely used in pharmaceuticals as an ingredient, solvent for processing, analytical reagent, and in the manufacturing of pharmaceutical products. So, according to pharmacopeia, different types of water are recommended as per the official book and chapter <1231>. Note: Information in this article doesn’t change the existing guidelines and regulations. It helps users understand … Read more
Sometimes, issues occur during the tablet manufacturing process; these are known as tablet manufacturing defects. Below is a detailed discussion of tablet manufacturing defects and their remedies, which helps in addressing these issues. To ensure and maintain product quality, tablets should be free from such visual defects. A pharmaceutical company that manufactures medicines may face … Read more
Modern pharmaceutical analysis relies on a range of instrumental techniques to ensure drug safety, efficacy, and regulatory compliance. Among these, UV-Visible (UV-Vis) spectrophotometry is universal in pharma R&D and QC labs. This method measures how much ultraviolet or visible light a sample absorbs, and through the Beer–Lambert law (absorbance ∝ concentration), it enables quantitation of … Read more
Active Pharmaceutical Ingredients (APIs) are the biologically active components of a drug responsible for its therapeutic effect. In a finished product (eg, tablet, capsule, injectable, etc.), the API provides the intended pharmacological action, while inactive excipients aid stability and proper delivery. In regulatory terms, ICH defines an API as “any substance… that, when used in … Read more
Launching a pharmaceutical manufacturing company is a hard startup journey that involves lots of planning, regulatory compliance, technical setup, and strategic marketing. Our pharmaceutical startup guide will introduce you with everything from market research and business planning to obtaining licenses, setting up GMP-compliant facilities, and marketing your products. It covers the step-by-step process from planning … Read more
The ISO 14644‑1 standard (2015 edition) is the global benchmark for cleanroom air cleanliness, defining nine classes (ISO Class 1–9) based on airborne particle counts. Each class sets maximum concentrations of particles ≥0.1, 0.2, 0.3, 0.5, 1.0, or 5.0 μm in a cubic meter of air. In practice, lower class numbers mean cleaner environments. For example, ISO Class 5 (used in … Read more
Below is a summary of the 10 most frequently observed audit findings in pharmaceutical manufacturing plants, followed by detailed descriptions, examples, preventive strategies, and relevant industry keywords. Each issue is based on industry reports and regulatory inspection data. Common Audit Finding: 1. Documentation and Record-Keeping Deficiencies: Deficiencies in documentation and records, such as missing or … Read more
Microbial testing of Non-Sterile Products: A Brief Overview of Pharmaceutical Microbiology Basics and History, Microbial Control Strategy, Risk Management for Non-Sterile Standards, and Testing and Acceptance Criteria for Non-Sterile Products. When examining the types of products that carry higher risks, sterile products require a complete absence of microorganisms. This is because they are typically administered … Read more
An uncontaminated environment is essential in pharmaceutical manufacture. Clean rooms created with strict ISO guidelines are engineered with the intent of reducing particulate and microbial contamination in drug manufacturing processes. However, microbial contamination may still be present owing to inadequate cooling, cleaning regimens, or even both. These controlled environments must comply with regulations which means … Read more
The WHO defines pharmacovigilance as “the science and actions connected to the detection, assessment, understanding, and prevention of adverse effects or any drug-related problems.” These Pharmacovigilance Interview Questions/ Answers are prepared by experts from Cognizant, Accenture, Novartis, IQVIA, Sanofi-Aventis, Merck, Covance, Pfizer, TCS, Bioclinica, and Syneous Health. Pharmacovigilance Interview Questions for Fresher Wipro Pharmacovigilance interview … Read more
A Pharmaceutical product’s quality is characterized as being pure, accurately identifiable, effective, and safe to use. Patients and customers have a moral (and legal) right to demand high-quality pharmaceuticals. The warehouse is responsible for all incoming items (including labeling and packaging) as well as the release of finished products, therefore it plays an important role … Read more
Learn about Standard operating procedures for Controlling and Storage Reference standards including Objective, Scope, Responsibility, Procedure, Storage and handling of reference standards, and Precautions. 1.0 Objective: To provide a procedure for controlling and storage of reference standards. 2.0 Scope: This procedure shall apply to all the reference standards that are used for analysis. 3.0 Responsibility:3.1 … Read more