Pharmaceutical Vendors Approval Manual
A Comprehensive Quality Manual for API and Packaging Material Approval
By: Erfan Syed Asif
Paperback | 29 January 2024
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This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendor's assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications.
This book
- provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements
- covers basic quality concepts and the elements of vendor's assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies
- provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry
- provides ready to use regulatory documentation, e.g. letter of commitment, questionnaire, SOP, etc. required for API and Packaging Materials contract
Provided material can be easily tailored to incorporate changes to add in-house vendor's qualification requirements.
Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.
ISBN: 9781032038131
ISBN-10: 1032038136
Published: 29th January 2024
Format: Paperback
Language: English
Number of Pages: 172
Audience: Professional and Scholarly
Publisher: Taylor & Francis Ltd
Country of Publication: GB
Dimensions (cm): 23.39 x 15.6 x 0.94
Weight (kg): 0.25
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- Non-FictionScienceBiology, Life Sciences
- Non-FictionEngineering & TechnologyIndustrial Chemistry & Manufacturing TechnologiesIndustrial ChemistryPharmaceutical Technology
- Non-FictionIndustry & Industrial StudiesMedia, Entertainment, Information & Communication IndustriesPrinting
- Non-FictionMedicineMedicine in General
- Non-FictionEngineering & TechnologyTechnology in GeneralEngineering in General
- Non-FictionMedicineOther Branches of MedicinePharmacology
- Non-FictionEngineering & TechnologyEnvironmental Science
- Non-FictionMedicineNursing & Ancillary ServicesPharmacy & Dispensing
- Non-FictionIndustry & Industrial StudiesManufacturing IndustriesChemical Industries
- Non-FictionEngineering & TechnologyMechanical Engineering & MaterialsProduction & Industrial EngineeringIndustrial Quality Control