PDA Letter

PDA Letter
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PDA Letter

 •  September 19

Four Months After PDA EU Annex 1 Workshop, Revision Still Eagerly Anticipated At the 2017 PDA Europe Revision of Annex 1 workshop, European regulators estimated a summer release of the long-awaited draft revision of the EMA guidance on GMPs for the manufacture of sterile drug products. Andrew Hopkins, MHRA, and Beate Reuter, Landesamt fur Soziale...

PDA Letter

 •  September 13

How Biogen optimized the Laboratory Asset Management Process As more companies seek to modernize operations, it goes without saying that they are taking another look at existing practices. In 2015, Biogen’s QC leadership developed a “Lab of the Future” vision for its laboratory operations with a goal to streamline and significantly automate the...

PDA Letter

 •  September 11

The European Medicines Agency (EMA) is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA is essential to the functioning of the single market for medicines in the EU. The agency will need to be relocated in the context of the UK's withdrawal from the EU. There have been 19 offers to host...

PDA Letter

 •  September 6

NNE’s Alex Severin discusses how to design for flexible engineering at the 2nd PDA Europe Annual Meeting in Berlin. Continuous Microbial Monitoring: Four Points to Consider Pfizer’s Jeffrey Weber discusses how biofluorescent particle counting can benefit a manufacturer’s operations. Cell and Gene Therapies: 5 Keys to Industrialization Karen Walker...

PDA Letter

 •  August 29

Visual inspection of injectables has become one of the most dynamic functions in pharmaceutical manufacturing. Advances in technology have given us a remarkable ability to assess the contents of individual parenteral units with increasing sensitivity. Noninvasive technology allows us to confirm the adequacy of container closure. Enhanced orthogonal...

PDA Letter

 •  August 29

The drive for patient-centric solutions and the emergence of novel drug products has led to the need for early understanding of container closure and delivery system suitability. A therapeutic product is fit for use when it meets established quality criteria with appropriate correlations between drug product quality and clinical performance. But...

PDA Letter

 •  August 29

Data integrity has been well established as a fundamental regulatory expectation under cGMP. Naturally, data integrity also applies to bacterial endotoxin testing (BET).

PDA Letter

 •  August 29

Aseptic processing presents many risks to sterile product. How can manufacturers address these risks to effectively prevent contamination?

PDA Letter

 •  August 29

Central to recent debates about disinfectant validation is whether value is added by individual facilities performing studies, or if a large central study could be relied upon to demonstrate the efficacy of biocides. Regulators expect disinfectant validation to be conducted by facilities in the pharmaceutical, biotech, medical device and 503B...

PDA Letter

 •  August 22

Implementation of an effective pharmaceutical quality system (PQS) is essential for a company to achieve product realization, establish and maintain a state of control, and facilitate continual improvement (1). According to ICH Quality Guideline Q10: Pharmaceutical Quality System, companies that apply the principles and concepts of ICH Q8:...