Pharmaguddu

Installation Qualification of Automatic Injectable Powder Filling With Rubber Stoppering Machine

Published on: April 21, 2024 by Naresh Bhakar

Installation Qualification Protocol of Automatic Injectable Powder Filling With Rubber Stoppering Machine is done to ensure that the system received matches the Design specification. SERIAL NO. ITEM DESCRIPTION 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW: 2.1 Objective 2.2 Purpose 2.3 Scope 2.4 Responsibility 2.5 Execution Team 3.0 ACCEPTANCE CRITERIA 4.0 REVALIDATION 5.0 INSTALLATION QUALIFICATION PROCEDURE 5.1 System … Read more

Operation Qualification of Sterilizing and Depyrogenation Tunnel

Published on: April 20, 2024 by Naresh Bhakar

Operation Qualification of Sterilizing and Depyrogenation Tunnel protocol aims to provide evidence that the installed Sterilizing and Depyrogenating tunnel will operate consistently within its full dynamic range as per the manufacturer’s specifications. SERIAL NO. ITEM DESCRIPTION 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW 2.1 Objective 2.2 Purpose 2.3 Scope 2.4 Responsibility 2.5 Execution Team 3.0 ACCEPTANCE CRITERIA … Read more

Installation Qualification of Sterilizing and Depyrogenation Tunnel (Protocol)

Published on: April 19, 2024 by Naresh Bhakar

IQ of Sterilizing and Depyrogenation Tunnel

Installation Qualification of Sterilizing and Depyrogenation Tunnel is done to ensure that the Sterilizing and depyrogenating tunnel system received matches the Design specification and also to ensure that it is properly and safely installed. Equipment Name: Steripack Sterilizing and Depyrogenation Tunnel Equipment No.: EQI/XX/XXX/01 Protocol Reference No. — Report No. — SERIAL NO. ITEM DESCRIPTION … Read more

Operation Qualification of Steam Sterilizer cum Bung Sterilizer (Protocol)

Published on: April 18, 2024 by Naresh Bhakar

The purpose of the Operation Qualification of Steam sterilizer cum Bung sterilizer protocol is to establish documentary evidence to ensure that the installed Steam sterilizer cum Bung sterilizer will operate reproducibly and consistently within its full dynamic range of operation according to the specifications of the manufacturer. Related Topic: Installation Qualification of Steam Sterilizer cum … Read more

Installation Qualification of Steam Sterilizer cum Bung Processor (Protocol)

Published on: April 17, 2024 by Naresh Bhakar

The purpose of the Installation Qualification of Steam Sterilizer cum Bung Processor protocol is to establish documentary evidence to ensure that it received matches the Design specification and also to ensure that it is properly and safely installed. 💡Related Topics: Area Qualification Protocol in Pharmaceuticals Protocol Contents for Steam Sterilizer cum Bung Processor IQ: SERIAL … Read more

Performance Qualification of Automatic Capsule Filling Machine

Published on: April 16, 2024 by Naresh Bhakar

Performance Qualification of Automatic Capsule Filling Machine defines the test procedures, documentation, references, and acceptance criteria to establish that the performance of the equipment shall meet the predetermined acceptance criteria. SERIAL NO. ITEM DESCRIPTION 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW: 2.1 Objective 2.2 Purpose 2.3 Scope 2.4 Responsibility 2.5 Execution Team 3.0 GENERAL CONSIDERATION/PREREQUISITE 4.0 REVALIDATION … Read more

Operational Qualification of Automatic Capsule Filling Machine

Published on: April 15, 2024 by Naresh Bhakar

Operational Qualification of the Automatic Capsule Filling Machine is done to get sufficient information and data about the machine and define the qualification and acceptance criteria to show that each criteria is proceed as per the Design specifications. Once the OQ is completed then, the equipment shall proceed to the next stage. Related: Installation Qualification … Read more

Microbiology Incubator: Principle, Working, Types, Parts, Use, Precautions and Limitations

Published on: April 4, 2024 by Naresh Bhakar

Learn about Microbiology incubators including their definitions, Working principle, Working essential components, usage, parts, different types of Incubators, advancement, Limitations, and Application. Incubator/ Definition: incubator is an essential device used in the microbiology section. Its insulated and enclosed design helps to control the environment. It also helps to control the temperature, humidity, and other parameters … Read more

What is Pharma 4.0 evolution and Examples: Brief Explanation

Published on: April 1, 2024 by Naresh Bhakar

Pharma 4.0 and basically, it is a need for future pharmaceuticals. Then the question arises as to why Pharma Industry 4.0 is a need for future pharmaceuticals, there are so many reasons let me tell you one thing: data integrity. Introduction: Pharma 4.0 You may be aware that so many companies are getting the observations … Read more

Defining a Pharmaceutical Isolator

Published on: March 26, 2024 by Naresh Bhakar

Isolator in pharmaceuticals has a significant place in the production of sterile products because of their decontaminated environment. They meet Grade A conditions and provide continuous isolation from its interior to the external environment. The Evolution of Aseptic Processing If we talk about their Journey, aseptic processing has been quite interesting, taking us from traditional … Read more

Pharma Guideline on How to Prepare SOP (SOP of SOP) with Formats

Published on: March 21, 2024 by Naresh Bhakar

Learn About SOP of SOP (How to Write SOP by implementing Different Fonts, Size, Title, Logo, Stamps, Formats, BMR/ BPR, Spec/STP, protocols, Worksheets, Reports, and Logbooks, and Annexures as per the Pharmaceutical Guidelines). 1.0 OBJECTIVE: 1.1 To lay down the procedure for the preparation of SOP (SOP on SOP), Format, Numbering, Review, Approval, Implementation, Distribution, … Read more

Installation Qualification Protocol for Automatic Capsule Filling Machine

Published on: March 16, 2024 by Naresh Bhakar

The purpose of the Installation Qualification Protocol for Automatic Capsule Filling Machine is to establish documentary evidence to ensure that the Automatic capsule filling machine system received matches the Design specification and also to ensure that it is properly and safely installed. SERIAL NO. ITEM DESCRIPTION 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW: 2.1 Objective 2.2 Purpose … Read more

Performance Qualification Protocol for Blister Machine

Published on: March 12, 2024 by Naresh Bhakar

Performance Qualification for Blister Machine

Performance Qualification Protocol for Blister Machine is designed to provide documented evidence that the functions of the equipment, which affect the product quality, equipment integrity, and safety of operating and maintenance personnel are considered. SERIAL NO. ITEM DESCRIPTION 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW: 2.1 Objective 2.2 Purpose 2.3 Scope 2.4 Responsibility 2.5 Execution Team 3.0 … Read more

Procedure for Handling of Deviations (SOP)

Last Updated on: March 23, 2024 by Pankaj Dept. Quality control

Learn About Standard Operating Procedure for Handling of Deviations in pharmaceuticals | Types of deviations | Deviation Flow chart | Devations Guidelines | Deviation Numbering | Deviation management. 1.0 OBJECTIVE: 1.1 To lay down that deviations from manufacturing instructions and quality-related procedures are recorded, investigated, and evaluated for their impact on product quality in a … Read more

SOP on Transfer and Receipt of bulk (ARM) from Warehouse to Production area

Published on: February 25, 2024 by Naresh Bhakar

SOP on Transfer & Receipt of bulk (ARM) from Warehouse to Production area

Learn About SOP on Transfer and Receipt of bulk (Active Raw Materials) from the Warehouse to the Production area. 1.0 Purpose: To describe the procedure for transfer and receipt of bulk (Active Raw material) from the warehouse to the production area (Vaccine Formulation). 2.0 Applicable: This Standard Operating Procedure applies to the transfer … Read more

Procedure for Thawing of Solution and Active Raw Material

Published on: February 24, 2024 by Naresh Bhakar

Learn About the Procedure for Thawing of Solution and Active Raw Material stored at or below -20 degrees C. 1.0 Purpose: To lay down the procedure for thawing of active raw material & solutions that are stored at or below -20 degrees C. 2.0 Applicable to: This Standard Operating Procedure is applicable for thawing of … Read more