Omslagsbillede

Modern Aspects of Pharmaceutical Quality Assurance Developing & Proposing Application models, SOPs, practical audit systems for Pharma Industry /

The pharmaceutical quality system ensures that the process performance is suitably achieved, the product quality is regularly met, improved opportunities are identified and evaluated, and the knowledge is constantly expanded. Auditing also plays a crucial role within the pharmaceutical industry. It...

Fuld beskrivelse

Saved in:
Bibliografiske detaljer
Institution som forfatter: SpringerLink (Online service)
Andre forfattere: Ghante, Minal (Editor), Potdar, Manohar (Editor), Bhusari, Vidhya (Editor)
Format: Electronisk eBog
Sprog:engelsk
Udgivet: Singapore : Springer Nature Singapore : Imprint: Springer, 2024.
Udgivelse:1st ed. 2024.
Fag:
Pharmaceutical chemistry.
Industrial policy.
Drug delivery systems.
Pharmaceutics.
Regulation and Industrial Policy.
Drug Delivery.
Online adgang:https://doi.org/10.1007/978-981-99-9271-3
Tags: Tilføj Tag
Ingen Tags, Vær først til at tagge denne postø!
Indholdsfortegnelse:
  • Chater 1 Introduction: Quality Assurance from Perspective of Pharmaceutical Industry
  • Chapter 2 Six-sigma Model in Pharma Industry (Part-I)
  • Chapter 3. Six-sigma Model in Pharma Industry (Part-II)
  • Chapter 4 Developing a practical audit system for a pharmaceutical industry based on six system inspection model
  • Chapter 5
  • Compliance Tools to Assist the Drug Industry for Regulatory Audits from Developed Countries
  • Chapter 6 Developing an Application Model for Planning, Controlling, Improving and Assuring Quality for Pharmaceutical Industry - covering Quality Planning and Quality Control
  • Chapter 7 Developing an Application model for Improving Quality for Pharmaceutical Manufacturing based on the Quality principle- covering Quality Improvement and Quality Assurance Audit
  • Chapter 8 Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP requirement for Tablets andCapsule Manufacturing Department
  • Chapter 9 Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP requirement for Liquid oral and Ointment Department
  • Chapter 10 Developing a simplified model Standard Operating Procedure to implement quality metrics for Pharmaceutical Manufacturing System
  • Chapter 11 Documentation and data integrity in Pharmaceutical Industry
  • Chapter 12 Quality Risk Management. Chapter 13 Deviation, Change control and CAPA.

Lignende værker