USER REQUIREMENT SPECIFICATION The User Requirements Specification (URS) outlines the business needs for what the equipment’s users need. URS are typically drafted early in the validation phase, often before the system is developed. URS is developed by the system owner and the end-users, with contributions from Quality Assurance. The requirements detailed in the URS are…
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SOP for operation of Metal Detector for automatic capsule filling machine Objective: To lay down a procedure for operation of metal detector. Scope: This SOP is applicable for the operation of metal detector to the formulation plant of PHARMACEUTICAL Company. Responsibility: Production Operator/ Technician – For operation of the machine. Production Officer/Executive-To ensure that operation…
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Pass Box A pass box is a component of a cleanroom setup designed to move materials from one side to another within a controlled setting to prevent contamination through the air. Its sole function is to transfer materials from one side to the other without causing any contamination issues, and it automatically removes any particles…
Pass Box The static pass-through hatch is used wherever transfer of material is required in between the clean room and non-clean room or in between the clean room if different classifications. The product is provided with a door interlocking system and a minimum component of germicidal light may be fitted on an optional basis. The…
MANAGEMENT REVIEW OF QUALITY METRICS Management review of quality Metrics procedure provides Monthly/ Quarterly Management Review and assessment of the performance of Quality and GMP systems. This document describes the activities of the Quality review meeting. SCOPE OF MANAGEMENT REVIEW OF QUALITY METRICS: This procedure applies to all facilities related to Production, Packaging, Testing, Holding,…
Temperature Mapping Temperature mapping involves systematically assessing temperature changes within a specific area. This area ranges from warehouses for storing temperature-sensitive pharmaceuticals to critical laboratory incubators needed for successful experiments. The goal is to detect potential areas of excessive heat or cold that may pose a risk to the quality and reliability of products, experiments,…
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Process analytical technology (PAT) — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance PAT FRAMEWORK PAT to be a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality. The term analytical…
SOP for environmental monitoring of air OBJECTIVE :To lay down a procedure for environmental monitoring of air. SCOPE :This SOP shall provide the procedure for monitoring the viable air borne count . RESPONSIBILITY :Microbiologist ACCOUNTABILITY Manager QC/QA PROCEDURE The microbial environmental conditions shall be monitored as per defined frequency and sampling schedule by active air…
Blister Packing Machine (BQS) The Blister Packing Machine consists of the following major stations Forming foil unwinding station This station is provided for various types of forming foils like PVC, PVDC, Alu-Alu, etc. The foil is clamped by the leading screw. The center distance concerning the base plate face is 170 mm, which can be…
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PURE NITROGEN PROTOCOL FOR PERFORMANCE QUALIFICATION Pure nitrogen is obtained by removing oxygen from the air in two stages. Oil-free compressed air is first dehumidified (anhydrous alumina is the desiccant) and is passed through a 0.01-micron filter and then a column of Carbon Molecular Sieve (CMS) where oxygen is adsorbed from this column. Then it…
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Pass Box for Clean room and it validation Definitions of Pass Box: Pass Box is specifically designed that aids in the material transfer without much personnel movement in clean rooms and also work like a barrier between classified and unclassified area.two types of pass box is used in pharmaceutical industry that is- 1.Static Pass Box 2….
Reynolds number and its importance in water system Purified water is the most used ingredient in pharmaceutical industries its used directly for the drug manufacturing process and also used for equipment’s cleaning. Purified water and Purified water generation and distribution system is one of the most important and critical part of a pharmaceutical facility and during designing purified water generation…
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To lay down a procedure for calibration of Weighing Balance XS – 204 DR SCOPE This Standard Calibration Procedure (SOP) is applicable in quality control area. RESPONSIBILITY Quality Control Officer/ Executive ACCOUNTABILITY Head –Quality Assurance PROCEDURE PRE STARTUP Check the cleaning of the weighing balance especially pan & display terminal. Check the power supply…
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Design Qualification of Pre-treatment & Purified Water Generation System For More Pharma Updates Visit –https://pharmaguidances.com
Factory Acceptance Test of Automatic Capsule Filling Machine Table of Contents System Information Protocol Details Protocol Approval from Customer The objective of this protocol Scope of this Protocol Definition of FAT and SAT Acceptance Criteria Responsibility Customer Requirements Performance Check Points & Testing Machine Sr. number details AF T Lab Factory Acceptance Report Approval Final…
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Zhejiang Ludao Technology Co., Ltd.(USFDA warning Letter) 2/23/18 For Warning Letter Click Here – Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Nan San (HK) Pharmaceutical Factory Ltd.(USFDA warning Letter) 2/23/18 For Warning Letter Click Here – Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Homeodynamics, LLC ( USFDA warning Letter ) 2/20/18 For Warning Letter Click Here – Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Alchymars ICM SM Private Limited USFDA warning Letter 2/16/18 For Warning Letter Click Here – Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
