Pharmaguddu

SOP for Cleaning and Operation of Linear Washing Machine

inside pharma production area, Showing A stainless steel table and a blue labelled file. the text on file written is "SOP for Cleaning and Operation of Linear Washing Machine".

1.0 OBJECTIVE: To lay down the procedure for cleaning and operation of linear bottle washingMachine 2.0 SCOPE: This procedure is applicable for cleaning and operation of linear bottle washing machine in Liquid department at Pharmaceutical. 3.0 RESPONSIBILITY:Operator, Officer, Executive- Production DepartmentOfficer, Executive- Quality Assurance DepartmentManager –Production and Quality Assurance Department. 4.0 DEFINITION(S):NA 5.0 PROCEDURE:5.1 Cleaning … Read more

SOP for Cleaning and Operation of Manufacturing Tank (capacity –1000 ltrs)

Set up procedure layout for cleaning and operation of manufacturing tank

1.0 OBJECTIVE: To lay down the procedure for cleaning and operation of manufacturing tank (capacity –1000 ltrs). 2.0 SCOPE: This procedure is applicable for cleaning and operation of manufacturing tank (capacity –1000 ltrs) at Liquid department in Pharmaceuticals. 3.0 RESPONSIBILITY:Operator, officer, executive – Production and QA departmentManager – Production and QA Department 4.0 DEFINITION(S)NA 5.0 … Read more

SOP for Cleaning and Operation of Leak Test Apparatus for Filled Bottles in Liquid Department

Leak test appratus machine showing desplay buttons and lab equipments in background

1.0 OBJECTIVE: To lay down the procedure for the Cleaning and Operation of leak test apparatus for filled bottles in Pharmaceutical lab. 2.0 SCOPE: This procedure is applicable to cleaning and operation of leak test apparatus, which is used for Leak test of filled bottles in liquid department at Pharmaceuticals. 3.0 RESPONSIBILITYOperator, Officer – Production … Read more

Cleaning Validation Protocol for Multi mill

Cleaning validation test request form for Multimill

1.0 OBJECTIVE: Cleaning Validation Protocol for Multi Mill is designed to ensure that the cleaning procedure for multi mill removes residues to the extent of compliance with pre-determined acceptance level. 2.0 SCOPE: This protocol applies to Pharmaceutical Manufacturing Facility. 3.0 RESPONSIBILITY: It is a joint responsibility of Quality Control, Production, and Quality Assurance departments. The … Read more

Cleaning Validation Protocol for Sifter

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

Compression Machine and Tooling, Types, Kit and Cleaning Process

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

Bowie Dick Test for Autoclave Validation

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 in Pharmaceutical

Visual Guide on Fogging vs Fumigation Comparison

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

Types of Water in Pharmaceutical, Usage and Technique to Prepare

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

Tablets Manufacturing Defects and Remedies in Pharmaceutical Manufacturing

A detailed images showing Various types of Images

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

Ultraviolet and Visible Spectrophotometer in Pharmaceutical Analysis

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): Definition and Overview

a scientist in a sterile white lab coat holds a small transparent vial containing a glowing blue liquid symbolizing the Active Pharmaceutical Ingredient (API)

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

Starting a Pharmaceutical Manufacturing Company: A Comprehensive Guide

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

ISO 14644‑1 Overview and Recent Revision

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

Top 10 Common Audit Findings in Pharmaceutical Manufacturing

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

Microbiology testing of non-sterile products

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