Privileges on application software
Privileges on application software HPLC Privileges on application software waters
Tag: Saxony
Process analytical technology (PAT) — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
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
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…
DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS)
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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PERFORMANCE QUALIFICATION PROTOCOL OF PURE NITROGEN
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 validaton
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
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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SOP on operation and cleaning of analytical balance used in aseptic area (Sartorious).
SOP on operation and cleaning of analytical balance used in aseptic area (Sartorious) Objective: To lay down a procedure for operation and cleaning of analytical balance used in the aseptic area (Make: Sartorious). Scope The SOP describes the procedure for operation and cleaning of analytical balance used in the aseptic area (Make: Sartorious). Responsibility Officers…
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Procedure for calibration of balance XS 204 DR.
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
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
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
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
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
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
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/
Nowcos Co.,Ltd USFDA warning Letter 2/14/18
Nowcos Co., USFDA warning Letter 2/14/18 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/
Bayer Pharma AG USFDA warning Letter 11/14/17
Bayer Pharma AG USFDA warning Letter 11/14/17 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/
Hangzhou Facecare Cosmetics Co., Ltd. USFDA warning Letter
Hangzhou Facecare Cosmetics Co., Ltd. USFDA warning Letter 11/17/17 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Dae Young Foods Co., Ltd. USFDA warning Letter 11/20/17
Dae Young Foods Co., Ltd. USFDA warning Letter 11/20/17 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/
BBCOS SRL USFDA warning Letter 11/29/17
BBCOS SRL USFDA warning Letter 11/29/17 For Warning Letter Click Here – For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/