The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation for recombinant or plasma-derived factor VIII products. Find out more.
Providing guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products the "Guideline on plasma-derived medicinal products" became effective in 2012. Read on here.
Antimicrobial resistance is an important issue for the marketing authorisation of veterinary medicinal products. On January, the European Medicines Agency published a concept paper for a guideline on antimicrobial resistance risk assessment. It is open for public consultation now. Find out more.
The European Commission has published the revised EU-GMP Chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely and also details additional requirements for recalling IMPs. Read more.
Japan is an interesting market, also for medical devices. There exists a translation of the relevant Japanese regulation in the English language as concerns the regulatory requirements on the quality assurance of medical devices. The Japanese Ministry of Health, Labour and Welfare issued a Ministerial Ordinance under the number 136 in 2004 which also is available in English. Read more.
Recently the EU Commission issued draft guidelines on the formalised risk assessment of pharmaceutical excipients. These drafts comprise definite specifications for determining the risk profile of the excipient and the manufacturer which the pharmaceutical manufacturer using these excipients has to apply. Read more.
Demonstrating the integrity and security of laboratory data, records, results and information is paramount for a successful inspection for any GMP regulated quality control laboratory. Please find in our News selected key citations regarding Laboratory Data Integrity in FDA Warning Letters from 2012.
Many in the GMP environment haven't realised the consequences of the so-called Generic Drug User Fee Act (GDUFA) yet. The FDA has now published the exact fee rates for facility inspections. Read more here.
The question arose if pharmaceutical water need to comply to the requirements of USP <232> with regard to elemental impurities, especially if water is the main component of a medicinal product. These requirements are much more tighten than the traditional test on heavy metals (pb) which has been replaced by the conductivity measurement. Read more.
The revisions of the chapters 3 and 5 of the EU GMP Guideline published in January concern exclusively the topic cross-contamination and the measures aimed at minimising the risk of cross-contamination. Read more.
At random intervals the Parenteral Drug Association (PDA) publishes so-called "Technical Reports" (TR) concerning GMP topics. They are a potential source to get more information on the state of the art concerning the respective topic. The PDA published the Technical Report No 29 on "Points to Consider for Cleaning Validation" as early as 1998. This report has now been published again in an updated version. Read more.
The procedures described in the pharmacopoeial texts for the determination of the density of powders now were judged to be equivalent in the three ICH regions Europe, USA and Japan and were published in the ICH Guideline Q4B Annex 13. You can obtain more information in this news.