Measures for contamination control are one of the basic requirements for the manufacturing of medicinal products. Still, contamination control issues got back in the TOP TEN List of 21 CFR 211 Citations. Read more about contamination control as an issue during inspections.
A site of the company Hospira in Italy received an FDA Warning Letter at the end of March which criticises among others defects concerning the closure of vials and the related possible microbiological contaminations. Read more about the Warning Letter.
In the Pharmacopeial Forum the USP has described the future requirements for packaging materials made of plastics. The original proposals were now revised, and new proposals were published with regard to the structure and content of the General Chapters on packaging materials made of plastics. For more information please see the Update of the USP Requirements.
In February 2015 the European Commission published a Concept Paper with the intent to revise the EU GMP Annex 1 on sterile manufacturing. The time frame provided by the EU Commission is very small. End of March 2015 has been set as deadline for industry comments and in October 2015 a draft version of the revised EU GMP Annex 1 is planned to be published. Read more about the industry comments on the revision of Annex 1 to the EU GMP Guide.
In an EDQM paper published in March 2015 the topic production of WFI by means of membrane-based technologies is discussed again and not excluded any more. Read more about WFI from membrane-based technologies.
Can an API manufacturer ask for an inspection to receive an EU GMP certificate? This is answered in the Question and Answers section of the EMA together with a question regarding the obligation to audit.
Just recently a so called "inspection tracker" was launched by Health Canada. Now, the agency offers an additional database which contains 3,821 inspections (per March 2015) which have been performed since 2012 - many of them outside Canada, e.g. in Europe or Asia. Please read more about the GMP Inspection database.
The new Guidelines for good manufacturing practice for excipients pack a punch. In parts the requirements go far beyond the terms of the guideline draft of February 2013. Read here what pharmaceutical companies have to observe from now on when ascertaining the appropriate good manufacturing practice for excipients by means of a formalised risk assessment.
The implementation of the Guideline ICH Q3D provides a great challenge for both drug manufacturers and active substances producers. Here, you can see the practical advice that the "Industry Coalition" makes available for the Control of Elemental Impurities.
In the course of implementing the GDP Guidelines special questions concerning temperature control are recurring. There exists an interesting questions and answers document of the German authorities on this issue.
Counterfeit medicines in the legal supply chain are increasingly becoming a problem. Experts are sure that counterfeiters will try more and more to sell fake medicines not only via the Internet, but through "infiltrating" them into the legal supply chain - meaning pharmaceutical wholesalers and pharmacies. Another case became known now. Read more in the news about the counterfeit drugs in the legal supply chain.
The EMA has formulated recommendations for the implementation of the requirements of the Guideline ICH Q3D for drugs which are already on the market. Read more about what the agency expects in the recently published document concerning "Elemental impurities in marketed products".
The MHRA revised their Data Integrity Guidance in the short term. Read in this news what the current "GMP data integrity definitions and guidance for industry" requires with regard to the GMP compliant handling of data and records.
Data Integrity has become one of the most important GMP compliance issues in the past two years. This has enormous consequences for the concerned companies but also for companies and authorities in EU and US. Again the US FDA has identified a company that violates regulations and put patients at risk. The company IPCA was already known for not meeting the GMP requirements. Read more about the GMP findings at IPCA and the consequences for companies and authorities dealing with Indian partners.
All Stakeholders dealing with Medicinal Products need to be registered and have to comply with GDP requirements. The MHRA has established a formalized procedure and also lists the brokers on their webpage. Read more about the Guideline for Brokers of Medicinal Products
The ZLG in Germany has published a new Aide Mémoire recently that provides inspectors with a guideline for the supervision of sterile manufacturers. Read more about the content of this New ZLG- Aide Mémoire for the supervision of sterile manufacturers.
Current scientific data on the occurance and risk of Posttransfusion Purpura (PTP) were published on the Advancing Regulatory Sciences site of the US Food and Drug Administration. Read more about the Data on Posttransfusion Purpura (PTP).
The FDA finalized the Guidance on "Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products". Read more about the new FDA Guidance.