Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech IndustriesSpanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati |
What people are saying - Write a review
Reviews aren't verified, but Google checks for and removes fake content when it's identified
User Review - Flag as inappropriate
Probably has a lot of typos and incorrect information in it. I ready the section on lyophilization and found Fo (lethality) information in the shelf mapping section. Also a few typos in the few pages that I looked at. So probably not a thorough book. I would recommend "Validation of Pharmeutical Processes" by Agalloco and Carleton which I use daily for all kinds of validation knowledge.
User Review - Flag as inappropriate
this is a very nice book to understand about the documentation and steps which should be taken in the pharmaceutical products manufacturing, quality control, quality assurance, validation, media fill run, packaging etc.
Contents
| 7 | |
VAL 30000 | 93 |
VAL 40000 | 115 |
VAL 50000 | 135 |
VAL 60000 | 149 |
VAL 70000 | 257 |
VAL 80000 | 335 |
VAL 90000 | 371 |
VAL 140000 | 475 |
VAL 150000 | 541 |
VAL 160000 | 617 |
VAL 170000 | 685 |
VAL 180000 | 867 |
VAL 190000 | 941 |
VAL 200000 | 979 |
VAL 210000 | 987 |
Other editions - View all
Validation Standard Operating Procedures: A Step by Step Guide for Achieving ... Syed Imtiaz Haider No preview available - 2001 |
Validation Standard Operating Procedures: A Step by Step Guide for Achieving ... Syed Imtiaz Haider No preview available - 2006 |
Common terms and phrases
________________________________________ Name/Title/Department ________________________________________ Acceptance criteria according action aseptic ATCC Attachment AUTHOR batch calibration challenge Check clean complete compliance container corrective count critical cycle described determine dilution distribution document drying Effective date endotoxin ensure environmental equipment Establish filter filtration floor flow Frequency growth heat identified incubation inspection installation issued limits load machine manager manual manufacturing materials measured media fill medium method microbial minutes mm/dd/yyyy Approved monitoring Name/Title/Department ________________________________________ Signature/Date once operating parameters particle performed personnel plate positive preparation pressure procedure Qualification quality assurance REASONS records reference responsible REVISIONS rinse sampling solution specifications speed STANDARD OPERATING PROCEDURE steam sterilization stoppers SUBJECT surface Table temperature TITLE tube tunnel units validation Verify vials volume washing
Bibliographic information
| Title | Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries |
| Author | Syed Imtiaz Haider |
| Edition | 2, illustrated, revised |
| Publisher | CRC Press, 2006 |
| ISBN | 1420009419, 9781420009415 |
| Length | 1144 pages |
| Subjects | › › Medical / Pharmacology Science / Chemistry / General |
| Export Citation | BiBTeX EndNote RefMan |