BMR Amlodipine Besylate Tablets 2.5 PDF (Sample)
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13 Prerequisites for Successful Validation
In this article let’s understand the Prerequisites for Successful Validation and Improving Validation Processes in Pharmaceutical Firms. Validation was implied in the 1960s, almost four decades ago. What has changed over the last 30 to 40 years? Has the overall understanding of the term improved? Have all responsible firms truly adopted validation? Are they doing … Read more
Design Qualification Of FBD in Pharmaceuticals
Learn the details contents and description of the Design Qualification Of FBD in Pharmaceuticals. CUSTOMER: XYX Pharmaceutical Company.LOCATION: XYZP.O. NO.:DATE:EQUIPMENT: FLUID BED DRYER MODEL: FBD GM 250 HW J.O. NO.:SERIAL NO.: CONTENTS S. NO. HEADING REMARK 1.0 OBJECTIVE & SCOPE 2.0 ACCEPTANCE CRITERIA 3.0 RESPONSIBILITIES 4.0 SYSTEM DESCRIPTION 5.0 … Read more
SOP on Good Documentation Practices
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 Automatic four head Vial Sealing Machine
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
Solid Dosage Forms: Tablets, Types, Quality Control Test
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
Operational Qualification of Automatic High-Speed Linear Vial Washing Machine (Protocol)
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
Validation Summary Report (VSR) along with Practical Approach
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
IQ of High Speed Linear Vial Washing Machine
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
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 of Automatic Injectable Powder Filling With Rubber Stoppering Machine
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
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)
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)
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)
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
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