Pharmaceutical Master Validation Plan
Pharmaceutical
Master Validation Plan
The Ultimate Guide to
FDA, GMP, and GLP Compliance
SL3305_ FM_fm Page ii Thursday, November 8, 2001 3:07 PM
Pharmaceutical
Master Validation Plan
The Ultimate Guide to
FDA, GMP, and GLP Compliance
Syed Imtiaz Haider, Ph.D.
ST. LUCIE PRES S
A CRC Press Company
Boca Raton London New York Washington, D.C.
SL3305_ FM_fm Page iv Thursday, November 8, 2001 3:07 PM
Every effort has been made to ensure that the contents of this generic validation master plan are accurate and that recommendations are appropriate and made in good faith. The author accepts no responsibility for inaccuracies or actions taken by companies subsequent to these recommendations. Library of Congress Cataloging-in-Publication …show more content…
The validation of utilities should ideally commence prior to that of support process equipment, and installation qualification prior to the operational qualification.
Define whether the facility is a new or existing one. Identify types of products or materials to be produced. Establish if any outside facility is involved as part of plan.
RESOURCE REQUIREMENT ESTIMATES
The effective execution of the VMP is based on how precisely the man-hour requirements are calculated for each task. Use input from experienced validation and engineering personnel. Consideration should be given to the time frame for protocol preparation, review, correction, and approval. Consider the analysis involved, the test equipment, and the time frame for procurement.
ELEMENTS OF VALIDATION MASTER PLAN
The elements described in the VMP are not the policy requirements.
However, they can be manipulated according to individual needs.
PLAN APPROVAL
Formal approval of the plan, indicating the top-level management for each function, is essential to share the responsibility. The VMP shall be supported with approval signatures from multidisciplinary functions, including
Engineering, Manufacturing, Quality Control, Quality Assurance, and Validation at a …show more content…
No other book in print deals exclusively with the key elements of a Validation Master Plan for a pharmaceutical plant and provides a hands-on template to be tailor made to achieve documentation compliance for FDA inspection.
The Validation Master Plan (VMP) is written to provide explicit instructions on how to achieve it for anyone responsible for writing and executing a VMP for drug, drug-device combination, diagnostic, pharmaceutical, biotechnology, and bulk pharmaceutical chemicals products. Included is the ready-to-use template that one can immediately use as one’s own without reinventing the wheel, thus saving time and money without missing any critical element.
This book provides instant answers to validation engineers, validation specialists, quality professionals, quality assurance auditors, and protocol writers regarding what should be made part of the VMP and how
Master Validation Plan
The Ultimate Guide to
FDA, GMP, and GLP Compliance
SL3305_ FM_fm Page ii Thursday, November 8, 2001 3:07 PM
Pharmaceutical
Master Validation Plan
The Ultimate Guide to
FDA, GMP, and GLP Compliance
Syed Imtiaz Haider, Ph.D.
ST. LUCIE PRES S
A CRC Press Company
Boca Raton London New York Washington, D.C.
SL3305_ FM_fm Page iv Thursday, November 8, 2001 3:07 PM
Every effort has been made to ensure that the contents of this generic validation master plan are accurate and that recommendations are appropriate and made in good faith. The author accepts no responsibility for inaccuracies or actions taken by companies subsequent to these recommendations. Library of Congress Cataloging-in-Publication …show more content…
The validation of utilities should ideally commence prior to that of support process equipment, and installation qualification prior to the operational qualification.
Define whether the facility is a new or existing one. Identify types of products or materials to be produced. Establish if any outside facility is involved as part of plan.
RESOURCE REQUIREMENT ESTIMATES
The effective execution of the VMP is based on how precisely the man-hour requirements are calculated for each task. Use input from experienced validation and engineering personnel. Consideration should be given to the time frame for protocol preparation, review, correction, and approval. Consider the analysis involved, the test equipment, and the time frame for procurement.
ELEMENTS OF VALIDATION MASTER PLAN
The elements described in the VMP are not the policy requirements.
However, they can be manipulated according to individual needs.
PLAN APPROVAL
Formal approval of the plan, indicating the top-level management for each function, is essential to share the responsibility. The VMP shall be supported with approval signatures from multidisciplinary functions, including
Engineering, Manufacturing, Quality Control, Quality Assurance, and Validation at a …show more content…
No other book in print deals exclusively with the key elements of a Validation Master Plan for a pharmaceutical plant and provides a hands-on template to be tailor made to achieve documentation compliance for FDA inspection.
The Validation Master Plan (VMP) is written to provide explicit instructions on how to achieve it for anyone responsible for writing and executing a VMP for drug, drug-device combination, diagnostic, pharmaceutical, biotechnology, and bulk pharmaceutical chemicals products. Included is the ready-to-use template that one can immediately use as one’s own without reinventing the wheel, thus saving time and money without missing any critical element.
This book provides instant answers to validation engineers, validation specialists, quality professionals, quality assurance auditors, and protocol writers regarding what should be made part of the VMP and how