NOTICIAS Y EVENTOS

U.S. Department of Health and Human Services Food and Drug Administration (US FDA) has issued a draft guidance on Computer Software Assurance for Production and Quality System Software on September 13th, 2022.

Importance of having principles of good documentation practice implemented in company procedures and day to day operations is evident from the outcome of Health Authority inspections.

The current version of the chapter is official as of February 1st, 2021. Pharmacopeial Forum, PF 48(3) proposed the revisions with a deadline for submitting comments by July 31st, 2022.

Today, 2nd September 2022, is the last day for MAHs in Europe to fulfill their responsibility.

The work plan includes specific activities to achieve an objective as well as routine activities that contribute to the overall strategic objective.

Chemicals Office of the Republic of Slovenia has drafted the amendment to the Rules on technical and organizational measures

European Medicines Agency (EMA) has published the 11th revision of the Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products

Data integrity continues to be one of the main topics during inspections conducted by competent authorities all over the world.

GAMP®5, a Risk-Based Approach to Compliant GxP Computerized Systems Guidelines, is a globally accepted standard for the validation of computerised systems that has been recently revised. In the end of July 2002, a new 2nd edition has been published.

Billev farmacija vzhod d.o.o. je uspešno podjetje z dolgoletno tradicijo, ki posluje v mednarodnem okolju. Smo eksperti na področju GxP, registracij, farmako(vigilance) in medicinskega svetovanja.

European Commission published the Implementing Regulation (EU) 2022/1107 to establish common specifications for certain class D in vitro diagnostic medical devices (IVD’s) considered to be high-risk.

U.S. Food and Drug Administration Agency (US FDA) is announcing the availability of a draft guidance for industry titled Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.