Description
- Provide 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
Book Information
ISBN 9781032038131
Author Erfan Syed Asif
Format Paperback
Page Count 152
Imprint CRC Press
Publisher Taylor & Francis Ltd