Facility Qualification - PharmOut

Slide 7 © PharmOut 2013 Planning for Facility Qualification Design Qualification Requirements Concept Design Design Drawings & Specs Design

  Design, Qualification, Design design, Qualification design qualification

The 10 Golden Rules of GMP - PharmOut

PharmOut white paper: The 10 Golden Rules of GMP PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151.

  Rules, Dongle, The 10 golden rules of gmp

Top 10 considerations when validating an autoclave

PharmOut white paper: Top 10 considerations when validating an autoclave PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151.

  Considerations, When, Autoclaves, Validating, Top 10 considerations when validating an autoclave

PIC/S GMP Guide – Annex 1 Revisions & Interpretations

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) recently introduced updated versions of both their GMP guide and the associated annexes, which deal with a variety of different specific

  Guide, Annex, Revisions, Gmp guide annex 1 revisions

How to implement Good Documentation Practices - PharmOut

PharmOut white paper: How to implement Good Documentation Practices PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151.

  Good, Documentation, Good documentation

BRIEFING - PharmOut

BRIEFING 〈1790〉 Visual Inspection of Injections. The General Chapters—Dosage Forms Expert Committee proposes this new chapter to provide guidance …

  Briefing

Restricted Access Barrier Systems & Isolators

Slide 2 © PharmOut 2017 Learning objectives We will Learn • What isolators are and why they were developed • The difference between a RABS and an isolator

<790> VISIBLE PARTICULATES IN INJECTIONS - PharmOut

General Chapters General Information Add the following: á1044ñ CRYOPRESERVATION OF CELLS INTRODUCTION Cryopreservation is the process of cooling and storing cells, tissues, or organs at very low temperatures to maintain their

EU GMP Guide-Annex 15 Qualification & Validation draft ...

EU GMP Guide-Annex 15 Qualification & Validation draft released In February 2014, a draft of the revised Annex 15 was released by the European Commission (EC) for public comment. The draft version is based on an EMA Concept Paper, published in November 2012 which outlined various reasons for the revision of Annex 15.

  Annex

Prevention of Contamination and Cross-Contamination in ...

©2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. ... have adequate space for placement of equipment as well as production and packaging materials ... before commencing manufacture of a subsequent batch Document the cleaning status of each equipment in logbooks General housekeeping

  2016, Placement, Status, Batch

A Review on Step-by-Step Analytical Method Validation

new analytical techniques in the pharmaceutical industries as a consequence, analytical method development has become the basic activity of analysis in a quality control laboratory. The reasons for the development of novel methods of drug analysis are: a) When there is no official drug or drug combination available in the pharmacopoeias.

  Development, Methods, Analytical, Analytical method, Analytical method development, New analytical

VALIDATION OF ANALYTICAL P TEXT AND METHODOLOGY …

determination of impurities and/or degradation products. 7. LINEARITY The linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample. 8. RANGE The range of an analytical procedure is the interval between the upper and lower

  Validation, Determination, Analytical, Validation of analytical

IS 4032 (1985): Method of chemical analysis of hydraulic ...

IS : 4032 – 1985 2 (Continued from page 1)Members Representing SHRI A. V. GOKAK Development Commissioner for Cement Industry (Ministry of Industry), New Delhi SHRI S. S. MIGLANI (Alternate) SHRI S. GOPINATH The India Cements Limited, Madras SHRI T. TAMILAKARAN (Alternate) SHRI A. K. GUPTA Hyderabad Industries Limited, Ballabagarh …

  Development, Methods

College of American Pathologists

Method Comparison • In this case, slope = 1.28, implying 28% higher results with new method; intercept = - 44, indicating absolute difference is 44 mm Hg lower with new instrument; r is low (0.911), indicating scatter of data • This would imply poor agreement between new, old method • Graph also identified two data outliers; in

  Methods, New method

WHO | World Health Organization

WHO | World Health Organization

  Health, World health organization, World, Organization