Pharmacovigilance Guidance Document Version 2.0
This Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products in India is in accordance with the objective of Drugs and Cosmetics Act, 1940 & Rules, 1945 including NDCT Rules 2019. This guidance document is prepared by the National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) in collaboration with Central Drugs Standard Control Organization (CDSCO) to facilitate submission of the safety profile of drugs by MAHs (MAH refers to manufacturer, marketer or the importer of the drug, who has valid manufacturing, marketing or import licence in India). This guidance document defines the roles & responsibilities of CDSCO, State(s)/UT(s) Drugs Controller, NCC-PvPI, IPC and MAHs in preparation of Pharmacovigilance System Master File by MAHs, Post Marketing Surveillance of Pharmaceutical Products, Preparation & Submission of Periodic Safety Update Report (PSUR), Quality Management System (QMS) at MAH organization, Audits and Inspection of Pharmacovigilance System at MAH organization and submission of Risk Management Plan, wherever applicable. This guidance document also provides assistance to MAHs on establishing and ensuring an elective Pharmacovigilance System at their organization. This guidance document may be amended from time to time after obtaining necessary approvals from the concerned authorities. To publish the Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products, Version 2.0, Expert Committee was constituted.
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.
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