Pharmaguddu

AHU Performance Qualification (PQ) Protocol: Environmental Monitoring & Validation Guide

Published on: May 8, 2026 by Naresh Bhakar

AHU performance qualification environmental monitoring with particle counter in cleanroom

AHU Performance Qualification (PQ) Protocol Objective: The objective of this protocol is to verify that the AHU consistently maintains required environmental conditions during routine operation. Learn the Previous Steps of AHU Qualification: Installation Qualification Protocol for AHUOperation Qualification Protocol for AHU 1.0 PROTOCOL APPROVAL: Submitting this page for Protocol No. is acceptance of the Appendix … Read more

AHU Operational Qualification (OQ) Protocol: Testing Procedures, Formats & Limits

Published on: May 8, 2026 by Naresh Bhakar

AHU operational qualification testing airflow velocity and HEPA filter integrity in cleanroom

AHU Operational Qualification (OQ) Protocol Objective: The objective of this protocol is to verify that the AHU operates within defined parameters such as airflow, pressure, and filter integrity. 1.0 PROTOCOL APPROVAL: Signing this approval page confirms that the qualification approach described in this protocol is accepted. If any change becomes necessary, it will be handled … Read more

AHU Installation Qualification (IQ) Protocol: Complete Guide with Format & Checklist

Published on: May 8, 2026 by Naresh Bhakar

AHU installation qualification checklist showing equipment setup verification in pharma cleanroom

AHU Installation Qualification (IQ) Protocol Objective: The objective of this protocol is to verify that the AHU is installed as per approved design specifications, drawings, and manufacturer recommendations. This AHU Installation Qualification (IQ) Protocol covers the following: Related Topic: Learn Operational Qualification and Performance Qualification of AHU. SERIAL NO. ITEM DESCRIPTION 1.0 Identification and inspection … Read more

SOP for Cleaning and Operation of Holding Tank (Capacity –3000 ltrs)

Published on: May 4, 2026 by Naresh Bhakar

1.0 OBJECTIVE: To lay down the procedure for cleaning and operation of holding tank(capacity –3000 ltrs). 2.0 SCOPE: This procedure is applicable for cleaning and operation of holding tank (capacity –3000 ltrs) in Liquid department Pharmaceuticals. 3.0 RESPONSIBILITY:Operator, officer, executive – Production departmentManager- Production Department 4.0 DEFINITION(S)NA 5.0 PROCEDURE for Cleaning and Operation of Holding … Read more

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

Published on: May 2, 2026 by Naresh Bhakar

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

Published on: May 1, 2026 by Naresh Bhakar

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

Published on: May 1, 2026 by Naresh Bhakar

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

Published on: May 1, 2026 by Naresh Bhakar

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)

Published on: May 1, 2026 by Naresh Bhakar

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

Published on: April 30, 2026 by Naresh Bhakar

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

Published on: April 30, 2026 by Naresh Bhakar

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

Published on: April 27, 2026 by Naresh Bhakar

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

Published on: December 24, 2025 by Naresh Bhakar

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

Published on: December 23, 2025 by Naresh Bhakar

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

Published on: December 23, 2025 by Naresh Bhakar

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

Published on: December 21, 2025 by Naresh Bhakar

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