June 23rd 2025
Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.
May 7th 2025
Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations regarding nitrosamines.
May 3rd 2025
The European Union is discussing ways to reduce Europe’s over-reliance on imports of APIs.
May 2nd 2025
While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.
April 18th 2025
Calculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.
Mylan Pharmaceuticals Issues Voluntary Recall of Insulin Glargine Injection
Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.
INTERPHEX 2022 Moves Back to Spring-time Schedule
Exhibitors display primary packaging, secondary packaging, and machine innovations at this year’s INTERPHEX.
FDA Revives Initiative to Identify and Reward Quality Drug Operations
FDA is reviving efforts to establish a Quality Management Maturity program.
The Role of Technology in CAPAs
Pharmaceutical Technology asked Jeff Elton, PhD, CEO of ConcertAI, about the role technology plays in performing CAPAs.
Teva Issues Voluntary Nationwide Recall of IDArubicin Hydrochloride Injection USP 5 mg/5 mL
Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.
Using ddPCR to Asses CAR-T Cell Quality
Standardization is needed in CAR-T cell therapy development due to its inherent complexity.
Determining the Best Estimate of Probability of Passing Multiple Stage Tests: Part 2—Dissolution
The author introduces a practical approach to determining the best estimate of probability for passing multiple stage dissolution tests.
Technology and CAPA
Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. Pharmaceutical Technology asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.
Put a Cap on CAPAs
Data may be used to improve (or remove) a corrective action/preventive action.
FDA Maps Strategies to Advance Pharmaceutical Quality
Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages.
Verifying Compendial Methods
Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.
Common FDA 483 Observations for Combination Products
Any improper validation of methods is likely to result in regulatory agency deficiencies that range in degree of severity.
In-Use Testing of Cleanroom Garments
Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.
A Method Validation Framework for Combination Products
The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications.
Contextualizing Computer Validation
Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape.
A New Route to Pharma GDP Compliance and Standardization
A consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines.
The Importance of Batch Record Reviews During Audits
Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.
Accelerating Workforce Training on Single-Use Technologies
Training is crucial for supporting GMP operations in commercial-scale bioprocessing.
What’s in Your Quality Manual?
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.
The Data Relationship
As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.
Mylan Recalls Semglee Prefilled Pens
The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.
Lohxa Recalls Senna Syrup
The company is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups because of microbial contamination.
Without a Particle of Doubt
Particle analysis provides assurances of the quality and performance of the final dosage form in pharmaceutical development.
Automation Helps Streamline Glycosylation Monitoring Workflow
Sample preparation tends to be manually labor intensive, but automating this step helps streamline the glycosylation monitoring workflow.
Advancing Enzyme Analysis Through Automation
Persistent bottlenecks in biocatalyst development can be alleviated through fully automated enzyme analysis.
Continued Process Verification for Cleaning Validation– Challenges and Pitfalls
Continued process verification for a cleaning validation program begins once the validation study is complete.
Quality Still a Priority
As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.
Good Manufacturing Practice on Demand?
Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.
Using Tolerance Intervals to Assess Conformance to Requirements
The authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.
Not a Particle of Doubt
Particle analysis is a critical component of pharmaceutical development, providing assurances of the quality and performance of the final dosage form.