Newsletter | November 5, 2019

11.05.19 -- Are Good Manufacturing Practices No Longer Good Enough?

Featured Editorial
Are Good Manufacturing Practices No Longer Good Enough?
By Mark F. Witcher, Ph.D.

Janet Woodcock’s recent quote on the state of pharmaceutical development — “It’s not working…” — should not be a surprise to anyone. The industry has been struggling for years with long development times, high product failure rates, and frequent quality problems. But, Ms. Woodcock’s further statement — “and, it won’t work in the future” — is an especially troubling call for changes.

Can Regulatory And Pharmacopeial Compliance Practices Establish Quality?
By Saeed Qureshi, Ph.D., Principal, PharmacoMechanics

The stated mandate of the regulatory authorities (e.g., the FDA) and pharmacopeias (e.g., USP) is that they establish and monitor safety, efficacy, and quality of the manufactured drug products that patients need. It is important to note that at the manufacturing stage, safety and efficacy are seldom — in fact, almost never — established and/or measured. Establishing the quality of the manufactured products acts as a surrogate for the safety and efficacy; hence, claims are always limited to the quality aspect.

Industry Insights
Why Early Investment In A Scalable Manufacturing Process Is Critical
Article | By Enrico Corona and Jonathan Sutch, Thermo Fisher Scientific

The failure of drug compounds in mid- to late-stage development is far more common than anyone would like it to be. Only about 30 percent of compounds successfully transition from Phase 2 to Phase 3.

How To Leverage Microcurrent High-Voltage Leak Detection (HVLD) Technologies
Article | By Oliver Stauffer, PTI Packaging and Inspection Systems

Using HVLD in the pharmaceutical industry means leveraging test method development on some products to validate other products.

The Benefits Of Aqueous Critical Cleaning In Pharmaceutical Manufacturing
Article | By Malcolm McLaughlin and Jeff Phillips, Alconox, Inc.

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of efficacy, minimal surface contact, reduced residue potential, and easier cleaning validation.

Keys To Consistent Bioprocessing
Article | By Serena Fries Smith, Thermo Fisher Scientific

The development of a robust and consistent bioprocess requires a systematic and risk-based approach to identify the right process parameters and raw materials.

Recommended Mixing Equipment For Tablet Coatings
Application Note | By Christine Banaszek, Charles Ross and Son Company

Designed for high-speed powder dispersion, the Ross Solids/Liquid Injection Manifold Mixer is well-proven in the preparation of tablet coatings. 

Getting What You Need In A Laboratory Hood
Article | Flow Sciences Inc.

Understand what information you should be communicating to the manufacturer to ensure you get the best lab containment equipment, built correctly the first time.

An End-To-End, Semi-Continuous Process For mAb Production
Application Note | GE Healthcare Life Sciences

See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.

Rapid Large-Scale Mixing Of Clumped Powder In Pharma Manufacturing
Application Note | ILC Dover

For operations where low-shear and high product integrity are required traditional technologies pose a risk to the quality of the final product.

The Influence Of Roller Compactor Process Parameters On Granule Properties
Application Note | Micromeritics Instrument Corporation

Processing powder blends can present a number of challenges: component powders may be poorly flowing in the process, the blends may be susceptible to segregation, or the formation of agglomerates may affect homogeneity. It is essential to identify powder properties that can be applied to characterize dry granulates in a relevant way and to optimize dry granulation processes. This application note investigates how process parameters influenced the properties of the dry granulate of a placebo formulation.

How To Properly Test Your Industrial Metal Detector
White Paper | Mettler-Toledo Product Inspection

This white paper provides an explanation of the differences between validation, verification, and routine performance monitoring, as well as an overview of recommended test methods for different types of metal detection systems.

3 Trends That Could Improve Air Cargo Shipping In Pharma Supply Chain
White Paper | Pelican BioThermal

There are three technology trends that could help mitigate airfreight logistics risks, reduce costs related to transportation issues and/or temperature excursions, and deliver high-quality drugs safely.

The 3 Cs You Should Expect From Your Pharma Service Provider
White Paper | Ropack Pharma Solutions

When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.  

  PDA Regulatory Training Course Series

Following the 2019 PDA/FDA Joint Regulatory Conference, dive into the regulatory details with your choice of seven training courses! Choose from training courses on CMC regulatory requirements in drug applications, sterile manufacturing, root cause investigations, quality and compliance management for virtual companies, cybersecurity risk management, and change management.

Life Science Training Courses
Writing Effective 483 And Warning Letter Responses


Implementing A Robust Change Control Program: Key Elements For Process And Documentation Compliance

Nov. 6, 2019 | 1:00 PM EST

Measuring CAPA Effectiveness: Critical Tips In Getting The Right CAPA And Showing It Works

Nov. 12, 2019 | 1:00 PM EST

21 CFR Part 11: Understanding The ERES Regulation For Compliance Success

Nov. 13, 2019 | 1:00 PM EST

Essentials Of Disinfectant Efficacy Testing: Ensuring Microbial Control

Nov. 14, 2019 | 1:00 PM EST

Preparing eCTD Submissions: A Step-By-Step Guide

Nov. 19, 2019 | 1:00 PM EST

Electronic Data Integrity In A GxP Environment: Managing The Data Life Cycle For Compliance

Nov. 20. 2019 | 1:00 PM EST

Establishing Appropriate Quality Metrics

Nov. 21, 2019 | 1:00 PM EST

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