- Retrait gratuit dans votre magasin Club
- 7.000.000 titres dans notre catalogue
- Payer en toute sécurité
- Toujours un magasin près de chez vous
- Retrait gratuit dans votre magasin Club
- 7.000.0000 titres dans notre catalogue
- Payer en toute sécurité
- Toujours un magasin près de chez vous
Pharmaceutical Vendors Approval Manual
A Comprehensive Quality Manual for API and Packaging Material Approval
Erfan Syed Asif
Livre relié | Anglais
175,95 €
+ 351 points
Description
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.
Spécifications
Parties prenantes
- Auteur(s) :
- Editeur:
Contenu
- Nombre de pages :
- 152
- Langue:
- Anglais
Caractéristiques
- EAN:
- 9781032030883
- Date de parution :
- 13-12-21
- Format:
- Livre relié
- Format numérique:
- Genaaid
- Dimensions :
- 156 mm x 234 mm
- Poids :
- 417 g
Les avis
Nous publions uniquement les avis qui respectent les conditions requises. Consultez nos conditions pour les avis.