GxP Audit

MHRA - GxP Data Integrity Guidance for Industry 

MHARA has publised GxP data integrity guidance for the industry.  It addresses fundamental failures identified by MHRA and international regulatory partners during GLP, GCP, GMP and GDP inspections; many of which have resulted in regulatory action. 

This document (PDF, 207KB, 14 pages) provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.

A WHO guide to good manufacturing practice (GMP) requirements

This guidance document has been prepared to aid vaccine manufacturers in the preparation and performance of the validation studies required by Good Manufacturing Practices (GMP) of the World Health Organization (WHO). The WHO GMP publications, other GMP Regulations/Guidelines and many publications on the concept and process of validation for pharmaceutical manufacture were consulted
during preparation of the Guide. These references are listed in Appendix 3. The emphasis in this guide is on WHO requirements for validation.

The whole 99 pages article is available for download at Downloads section of FarmavitaR+.

Confession of GMP-certificates in Ukraine

The Ministry of Health of Ukraine issued an order #896 concerning the renewed GMP-certificate by vendors for selling drugs on the territory of Ukraine.
"Good manufacturing practice" or "GMP" is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.

Understanding USP 71 Sterility Tests and Extended BUD

One of the most frequently asked questions recently asks how to extend the Beyond-Use Date (BUD) of compounded sterile preparations (CSPs). Eric S. Kastango, RPh, MBA, FASHP, reviewed the requirements of USP Chapter 797 necessary to complete in order to extend BUD. The use and limitation of sterility tests according to USP 71 was reviewed, along with process verification.

Ukraine in prospect of joining PIC/S

19-20 May 2010 in Geneva a meeting of the Executive Committee of the PIC / S was held. The Ukrainian delegation, headed by Alexei Soloviev, Chairman of the State Inspectorate for Quality Control of Drugs Ministry of Ukraine, Chief State Inspector of Ukraine for Quality Control of Drugs.

Pharmaceutical Inspection Cooperation System - PIC / S - an international agreement between national regulatory authorities in the field of drug quality control, design and implementation of standards of Good Manufacturing Practice (GMP).

Management Principles of ISO in Business Continuity Management

There are many risks that may threaten any organization by disrupting its business processes. The spectrum of risks and threats may start as a leakage in the supply pipe and may also extend to cyber crime and terrorism. Business Continuity Management serves as an ongoing process, submerged in the basic management principles of an organization including disaster recovery, business recovery, business resumptions and contingency planning.