Learn in Detail about the Procedure (SOP) of Good Documentation Practices | Good Documentation Practices FDA Guidance | 5 Principles of Good Documentation Practices. 1.0 AIM: To lay down procedure on Good Documentation Practice in Pharmaceuticals areas. 2.0 PURPOSE: The purpose of this Standard Operating Procedure is to define the entry in the document records … Read more
Installation Qualification protocol for the Automatic four head Vial Sealing Machine has the following contents: 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 CRITERIA 5.0 INSTALLATION QUALIFICATION PROCEDURE 5.1 System Description 5.2 Instruction for Filling the Checklist 5.3 … Read more
Tablets are solid dosage forms that are manufactured worldwide in the pharmaceutical industry. These are manufactured by molding or by compression method. Tablets or capsules come in the solid dosage form categories. Examples of solid dosage forms include tablets, capsules, powders, dry powders, and sachet. What are Tablets in Pharmaceuticals? Tablets are unit, solid dosage forms that contain one … Read more
The Automatic High-Speed Linear Vial Washing Machine protocol is designed to establish document evidence that the installed machine is operating as per the manufacturer’s specification. Related: IQ of High-Speed Linear Vial Washing Machine 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 … Read more
In this article, we will discuss the validation summary report for a computerized system in the pharmaceutical industry. The following section explains 10 components of VSR along with examples and statements. What a Validation Summary Report? Let’s understand what a validation summary report is. It’s a report where you capture all the details of performed … Read more
Installation Qualification of High Speed Linear Vial Washing Machine protocol is to establish documentary evidence to ensure that the Automatic High-Speed Linear Vial Washing Machine with two conveyor belts (one for loading the vials to the washing machine and another for unloading from the washing machine) received matches the Design specification. Related: Area Qualification Protocol … Read more
Operational Qualification of Automatic Injectable Powder Filling With Rubber Stopping Machine protocol shall define the test procedures, documentation, references, and acceptance criteria to establish that the machine operates and performs as intended in accordance with the design qualification. Related: Installation Qualification of Automatic Injectable Powder Filling With Rubber Stoppering Machine SERIAL NO. ITEM DESCRIPTION 1.0 … Read more
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 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 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
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
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 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 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
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
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