Syed Imtiaz Haider

Cleaning Validation Manual (eBook, PDF)

A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries

• Format: PDF

Produktbeschreibung

With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors' more than two decades of experience, the text offers hands-on training based on current approaches

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 608
• Erscheinungstermin: 24. Mai 2010
• Englisch
• ISBN-13: 9781439826614
• Artikelnr.: 57534217

Autorenporträt

Syed Imtiaz Haider and Erfan Syed Asif are with Gulf Pharmaceutical Industries in the United Arab Emirates.

Inhaltsangabe

CLV
1 How to Establish a Cleaning Validation Program. CLV
2 Introduction. CLV
3 Scope and Approach. CLV
4 Cleaning Validation Team Members and Responsibilities. CLV
5 Cleaning Validation Philosophy, Strategies, and Methodology. CLV
6 Planning Phase. CLV
7 Execution Phase. CLV
8 Analytical Testing and Reporting Phase. CLV
9 Equipment Description. CLV
10 Facility Description. CLV
11 Utilities Description: DIW, WFI, Steam, and Compressed Air. CLV
12 Utilities Monitoring and Microbiological Control. CLV
13 Equipment Cleaning Materials/Detergent Description. CLV
14 Microbiological Cleaning of Equipment Surface. CLV
15 Solubility of Active Materials in Water. CLV
16 Toxicity of Active Materials. CLV
17 Cleaning Validation Products Grouping Matrix (Tablets, Capsules, and PPS). CLV
18 Product/Equipment Train Matrix (Tab
Cap
PPS). CLV
19 Worst
Case Products (Tablets, Capsules, and PPS) Matrix. CLV
20 Validation with Corresponding Cleaning Procedures. CLV
20.1 Cleaning Validation Protocol for Fluid Bed Dryer. CLV
20.2 Cleaning Validation Protocol for Mixer. CLV
20.3 Cleaning Validation Protocol for Granulation Machines (Type A). CLV
20.4 Cleaning Validation Protocol for Powder Bins. CLV
20.5 Cleaning Validation Protocol for Tablet Press. CLV
20.6 Cleaning Validation Protocol for Sieve. CLV
20.7 Cleaning Validation Protocol for Powder
Filling Machine. CLV
20.8 Cleaning Validation Protocol for Encapsulation Machine. CLV
20.9 Cleaning Validation Protocol for Film Coating Pan. CLV
20.10 Cleaning Validation Protocol for Sugar Coating Pan. CLV
21 Cleaning Validation Product Grouping Matrix (Syrup). CLV
22 Cleaning Validation Product/Equipment Train (Syrup). CLV
23 Worst
Case Products (Syrup). CLV
24 Cleaning Validation Product Grouping Matrix (Suspension). CLV
25 Product Grouping/Equipment Train Matrix (Suspension). CLV
26 Worst
Case Products (Suspension). CLV
27 Product Grouping Matrix (Drops). CLV
28 Product/Equipment Train (Drops). CLV
29 Worst
Case Products (Drops). CLV
30 Cleaning Validation Product Grouping Matrix (Cream/Ointment). CLV
31 Product/Equipment Train (Cream and Ointment). CLV
32 Worst
Case Products (Ointment and Cream). CLV
33 Product Grouping Matrix (Suppositories). CLV
34 Cleaning Validation Product/Equipment Train (Suppositories). CLV
35 Worst
Case Products (Suppositories). CLV
36 Cleaning Validation Protocols Products (Suppositories). CLV
36.1 Protocol for Manufacturing Vessel. CLV
36.2 Protocol for Bin Washing Station. CLV
36.3 Cleaning Validation Protocol for Syrup Holding Tank. CLV
36.4 Protocol for Filling Station and Filter Assembly. CLV
37 Cleaning Validation Product Grouping Matrix (Sterile). CLV
38 Cleaning Validation Product/Equipment Train Matrix (Sterile). CLV
39 Validation Protocols Biological and Sterile Products. CLV
39.1 Cleaning Validation Protocol for Freeze Dryer. CLV
39.2 Cleaning Validation Protocol for Glass
Lined Mobile Tank. CLV
39.3 Protocol for Preparation and Holding Vessel for Egg Protein. CLV
39.4 Protocol for Filtration Assembly. CLV
39.5 Protocol for Preparation and Holding Vessels for Biological Products. CLV
39.6 Protocol for Filtration Assembly and Filling Machine for Biological Products. CLV
40 Cleaning Validation Tentative Plan (Schedule). CLV
41 Cleaning Validation Sampling and Testing Status. CLV
42 Cleaning Validation Regulatory Guidelines. CLV
42.1 Guide to Inspections Validation of Cleaning Processes. CLV
42.2 WHO Good Manufacturing Guidelines for Cleaning Validation. CLV
42.3 Health Products and Food Branch Inspectorate Guidance Document Cleaning Validation Guidelines GUIDE
0028. CLV
42.4 Qualifi cation and Validation. CLV
43 Sampling Tools. CLV
44 Recommended Readings.