Newsletter | August 1, 2019

08.01.19 -- 4 Trends In Recent FDA Warning Letters To OTC Drugmakers -- And How To Avoid Them

Featured Editorial
4 Trends In Recent FDA Warning Letters To OTC Drugmakers — And How To Avoid Them
By Alan D. Greathouse, The FDA Group, LLC

A recent flurry of warning letters issued to manufacturers of OTC drug and health products has revealed similar deficiencies related to current good manufacturing practice (cGMP) and quality management expectations.

Equipment Change Control For GMP Production Facilities: Proving It All Works
By Greg Weilersbacher, Eastlake Quality Consulting

The first article in this two-part series outlined the six primary stages of equipment change control and discussed the first two stages: (1) determining the equipment utility/IT requirements and (2) preinstallation assessment, utility evaluation, and remediation. This article describes the final four stages of this process: (3) evaluating the impact of new equipment installation on previously validated utilities, (4) executing validations for new equipment, (5) review of equipment turn-over packages and validation reports, and (6) performing change control effectiveness checks.

Industry Insights
Viral Clearance: 7 Chromatography Column Considerations
Article | By Linnea Troeng, GE Healthcare Life Sciences

Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging. Here are seven things to consider while performing your next chromatography viral clearance study.

Factors To Consider During Tablet Compaction Scale-Up
Article | By Kevin Queensen, Natoli Engineering Company, Inc.

How factors such as R&D vs. production press, as well as compaction dwell time, can affect your scale-up.

Is Your Biologic At Risk For Protein Aggregation? Part 1
Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne Contract Manufacturing

This is the first installment in a three-part series that examines what causes protein aggregation and practical steps you can take to mitigate the risk.

Overcoming Challenges Associated With Biologic Drug Formulation And Development
Article | By Victoria Morgan, West Pharmaceutical Services, Inc.

Biologic manufacturing subjects the formulation to different stresses and conditions that may compromise quality and stability. Recently, the requirement for the development of subcutaneous formulations for high-dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges, including degradation. Read about how wearable technology offers new alternatives that were not previously possible due to historically binding parameters for formulators.

Bioprocess Containers: Materials Of Construction
White Paper | Thermo Fisher Scientific

Several characteristics are important to the performance of bioprocess containers (BPCs), including biological compatibility, physical and mechanical properties, and extractables and leachables (E&L).

Managing The Challenges Of Controlled Room Temperature Requirements
White Paper | Pelican BioThermal

Controlled room temperature cold chain packaging has many uses, but this versatile product also has challenges that are unique due to its requirement that the payload be kept between 15° C and 25° C.

The Role Of pH And Residue In Pharmaceutical Cleaning
White Paper | Alconox, Inc.

A great deal is known about how pH affects aqueous critical cleaning. Typically, alkaline cleaners are used on oily residues and acidic cleaners are used on inorganic residues.

A QbD Approach To Continuous Tablet Manufacture: Utilizing The FT4 Powder Rheometer And The GEA ConsiGma Twin-Screw, High-Shear Granulator
Application Note | Micromeritics Instrument Corporation

In order to maximize the benefit of continuous processing, and obtain regulatory approval, it is necessary to establish the link between the processing parameters and the product attributes — something that is difficult to achieve due to the insensitivity of many traditional methods for powder and granule testing. This study summarizes initial work between Freeman Technology and GEA, which has explored the relationship between granule properties and variation in formulation and processing parameters in a continuous manufacturing environment.

The Criticality Of API CDMO Selection: Insights From A Client
Case Study | Thermo Fisher Scientific

4SC AG, a clinical-stage biopharmaceutical company partnered with Thermo Fisher Scientific Pharma Services, has an experienced team that helped them overcome active pharmaceutical ingredient (API) manufacturing hurdles, leading toward commercial success.

  Clinical Trial Supply Southeast 2019

October 2 and 3, 2019 | Durham, NC

CTS Southeast will return to North Carolina in 2019 to look at ongoing regulations, enhancing the supply chain, and making sure the right systems are in place. Top trial sponsors and regulatory bodies such as GSK, G1 Therapeutics, PRA Health Sciences, GS1, and many more came together to share their insights into achieving a compliant and error-free supply chain.

Benchmarking The Pharma Industry’s Market Research Function
ISR Reports
AEROTRAK Remote Particle Counters: Models 7310-A3F And 7510-A2F
TSI Incorporated
Introducing Seal-Sensor: A PTI Airborne Ultrasonic Technology
PTI Packaging and Inspection Systems
Elemental Impurities Emerge As New Compliance Challenge
By Adam C. Fox, senior vice president, Analytical Operations, Nitto Avecia Pharma Services
Scientific Search: Intelligent Knowledge Management
Dassault Systemes Americas
Life Science Leader Magazine

Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.