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GMP MANUAL: GMP-Verlag Peither AG


GMP MANUAL Volume 1 Manufacturing Production; Packaging; Laboratory and Analytical Control and Documentation

ISBNs: 9783934971745(ISBN-10: 3934971741)


Handbook of Investigation and Effective CAPA Systems

Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs.

Enhancements to this third edition include:

A new section linking the investigation and CAPA programs with the overall quality culture of the company

Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485

Updated inspectional observations from the U.S. FDA and U.K. MHRA

A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process

New charts and information related to the investigation of human errors; the human factor section includes information about training and competence

A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results

Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error

Jose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.


Pharmaceutical Quality Assurance guidelines, 10th edition

The 10th edition of the Quality assurance of pharmaceuticals: a compendium of guidelines and related materials is an essential resource for the global healthcare community, designed to strengthen pharmaceutical standards worldwide.

The compendium, developed for national regulatory authorities, pharmaceutical manufacturers, healthcare professionals, and procurement agencies, is instrumental in upholding the globally acceptable standards of good manufacturing practices (GMP) and inspections. With forty-six guidelines, including eight new and ten revised ones, it provides a comprehensive framework for enhancing regulatory systems and international standards for pharmaceutical quality assurance.

The recent alerts on contaminated paediatric syrup medicines underline the urgency for strengthened measures in pharmaceutical manufacturing and for Member States to enforce these international standards to safeguard public health. Applying internationally acceptable standards supports local and regional production of medicines and the quality and safety of medicines circulating in international commerce.

In the context of global healthcare, the 10th edition of the WHO Quality Assurance of pharmaceuticals compendium, volume 2, is a commitment towards ensuring the quality, safety, and efficacy of pharmaceuticals worldwide. The compendium is one of several WHO initiatives aimed to strengthen quality assurance and access to medicines.