Change Control system SOP: Initiation, Review, Assessment, Format, Numbering, Approval and closing

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Close-up of a blue SOP file on a stainless steel table in a pharmaceutical production area, labeled “Change Control System SOP; Initiation, Review, Assessment, Format, Numbering, Approval and Closing,” with a chemist’s gloved hands resting beside it and blurred equipment in the background.

Change Control system SOP, including preparation of Format, Numbering, Initiation, Change & Assessment by QA, Review, Approval, Implementation, Distribution, Retrieval, Annexures, and closing of change control. 1.0 OBJECTIVE: To lay down the procedure for Change Control system SOP. 2.0 SCOPE: This Change Control system SOP is applicable to all related user departments as specified in … Read more

SOP for Cleaning and operation of sparkle filter press

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Image showing pharma production area, inside it, A stainless steel table and a blue labelled file. the text on file written is "SOP for Cleaning and operation of sparkle filter press".

1.0 OBJECTIVE: To lay down the procedure for Cleaning and operation of sparkle filter press. 2.0 SCOPE: This procedure is applicable for cleaning and operation of sparkle filter press in liquid department at Pharmaceuticals. 3.0 RESPONSIBILITYOperator, Officer, Executive- Production DepartmentOfficer, Executive- Quality Assurance DepartmentManager –Production and Quality Assurance Department. 4.0 DEFINITION(S)NA 5.0 PROCEDURE for Cleaning … Read more

SOP for cleaning and operation of Carton Over Printing Machine

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SOP for cleaning and operation of Carton Over Printing Machine

1.0 OBJECTIVE: To lay down a procedure for cleaning and operation of carton over printing machine. 2.0 SCOPE: This procedure is applicable for cleaning and operation of carton overprinting machine in production department at Pharmaceuticals. 3.0 RESPONSIBILITYOperator, Officer, and Executive – Production DepartmentManager – Production Department 4.0 DEFINITION(S)NA 5.0 PROCEDURE: for Carton Over Printing Machine5.1 … Read more

SOP for Cleaning and Operation of Linear Washing Machine

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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)

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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

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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

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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

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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

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Compression machine and tooling

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

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Guide to Bowie-Dick Autoclave Test

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

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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

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Types of water

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

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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

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Ultraviolet and Visible Spectrophotometer

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

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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

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Pharmaceutical Manufacturing Company

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