Best Practices

The increased flow of data from laboratory studies requires a data management strategy to optimize study success.

Open communication and transparency coupled with technical expertise foster strong long-term manufacturing partnerships.

As mergers continue and operations become more complex, simplifying procedures and training can prevent costly morale, quality, and compliance problems.

Sharp has invested US$650,000 into enhancing its Interactive Response Technology (IRT) solution.

Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.

A look at some best practices to ensure that quality control is maintained in the client–vendor relationship.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has made two significant changes to its new 2019 Code of Practice with the aim of boosting business integrity on a global scale.

Mock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.

Preventing problems in implementing a manufacturing execution system requires upfront analysis and detailed planning.

The combination of translatable in-vitro and in-vivo assays, coupled with expertise in immunology and oncology helps facilitate the progression of novel oncology therapeutics from hit identification to investigational new drug submission.

Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.

Designing a mechanical integrity program using existing best practices can help pharmaceutical manufacturers comply with OSHA’s standard for process safety management.

How warehouse execution systems can help in case of a drug recall.

This article presents considerations for preventing hazards associated with dust in pharmaceutical production, particularly as relates to the United Kingdom's Control of Substances Hazardous to Health (COSHH) Regulations.

Materials used in the seals of split butterfly valves for aseptic pharmaceutical manufacturing should be chosen carefully.

An architect's evaluation early in a pharmaceutical facility relocation and design process can help identify potential problems.

Understanding what affects a measurement and implementing appropriate procedures will aid weighing accuracy.

Preventative maintenance of heat transfer fluid systems is important for reducing downtime in pharmaceutical manufacturing.

Regenerative thermal oxidation (RTO) has become a common solution to treat volatile organic compounds (VOC) and hazardous air pollutants (HAP) present in the emissions of many pharma production processes. Regenerative thermal oxidation devices used to treat halocarbons should be designed to prevent corrosion. Anguil Environmental Systems explains best practices for addressing potential fail points in the materials of construction when designing process emission handling systems.

Artificial intelligence offers a number of opportunities in pharmaceutical drug development and manufacturing, but there are barriers to overcome, notably around how well and how quickly the regulatory environment can adapt and keep pace with to the rapid changes.

Electronic systems allow biopharma manufacturing companies to meet data integrity requirements and optimize practices.

A rigorous approach to industrial security is essential for protecting intellectual property and product integrity in connected pharmaceutical operations.

Learn how to prevent common causes of product loss.

igital tracking of overall equipment effectiveness can improve efficiency.

Integrating EBRs with MES reduces time to market, cuts costs, and enhances compliance performance.

To prevent failure during lengthy use, tube life should be monitored and a preventive maintenance program enacted.

An enterprise quality management software system can minimize human error and help pharmaceutical manufacturers maintain standard operating procedures to prevent deviations from GMP resulting from not having or following written procedures.

The new ISPE Containment Manual is a summary of the process involved in the manufacture of highly active or highly hazardous pharmaceutical substances.

The pharmaceutical industry now has a way to accurately evaluate and compare dust collection systems that are self-cleaning

This article looks at five of the most common hurdles in packaging and labelling artwork and how to avoid them.