Validation & Qualification

IQ OF AUTOMATIC ROTARY TYPE MEASURING CUP PLACEMENT Contents Pre Execution Approval Objective Equipment Description Participants Log Installation Qualification Checklist Sub-Component CheckList Component Location List MOC Verification List Test / Inspection Reports Utility Verification List Attachment Log Summary, Conclusion, and Recommendation Abbreviations Post Execution Approval PRE-EXECUTION APPROVAL Prepared by By …

DESIGN QUALIFICATION OF AUTOMATIC VERTICAL ROUND BOTTLE STICKER LABELLING MACHINE The Automatic Vertical Round Bottle Sticker Labeling Machine is one of the most users friendly. The machine is used for full/partial wrap around labeling on different size of round containers. It is capable of labeling up to 80 to 120 …

TURN TABLE Turntables are horizontal, rotatable powered table mechanisms for transferring material/container between conveyors that are in angular relation to one another.  They often provide both loading and unloading of their contents to and from a conveyor.  In order to increase productivity and ergonomics in any manufacturing operation, equipment such …

User requirement specification (URS) of Tablets Automatic Coating Machine User requirement specification (URS) of Tablets Coating Machine is a list of all the requirements from the user, After the preparation of the list, the documents are sent to the manufacturer to get the required materials as per the given criteria. …

HVAC systems for non-sterile pharmaceuticals as per WHO TRS. 937, 2006,Annex 2 Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms 1. Introduction 2. Scope of document 3. Protection 3.1 Products and personnel 3.2 Air filtration 3.3 Unidirectional airflow 3.4 Infiltration 3.5 …

Temperature mapping of storage areas The purpose of a temperature mapping study is to document and control the temperature distribution within a storage area. Temperature mapping of storage areas is a systematic mapping procedure in any cold room, freezer room, or another temperature-controlled store. This guideline does not cover the …

VIAL WASHING MACHINE PQ PROTOCOL TABLE OF CONTENTS S. No. Description 1.0 Protocol approval 2.0 Overview 2.1 Purpose 2.2 Scope 2.3 Responsibilities and identification of execution team 3.0 Pre-Validation requirement 4.0 Equipment description 5.0 Validation procedure 6.0 Sampling plan and Acceptance criteria 7.0 Validation report 8.0 Validation approval 9.0 Observed …

Design Qualification of Gelatin Colour Mixer OBJECTIVE: To design, engineer and supply the Gelatin Colour Mixer and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in …

PURPOSE: To describe the Installation Qualification of Gelatin Storage Vessel its accessories and to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification . Aid verification of the installation as per equipment general arrangement Drawing. Ensure that the system …

Principles of HVAC Duct Design in the Pharma Industry How Does a Duct System Work  The duct, or air distribution, system used in cooling and heating your area is a collection of tubes that distributes the heated or cooled air to the different rooms in the Pharma Industry. This branching …