The traditional outlook on cleaning validation might look inexpensive and safe, but it can lead to serious problems in the long run. To modernize your cleaning validation strategy for 2023, here are four areas to focus on.
- Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues
- Frequent Deficiencies In GMP Inspections, Part 3
- Considerations For Sterility Test Methods When Working With CDMOs
- New Approaches For Drug Substance Freezing And Storage
- FDA Adopts ICH Final Guidance On Bioanalytical Method Validation
- AI/ML In Drug Discovery & Development: Potential And Challenges
- Calculating The Probability Of Passing The USP Dissolution Test
Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues
ASTM has published the revision of ASTM E3263 "Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues.” This article, written by the ASTM revision team itself, explains the reasons behind the revision and delves into the key updates.
Frequent Deficiencies In GMP Inspections, Part 3
Don't let cleaning and disinfection methods work against you. Without a system to track cleaning chemicals and equipment, how do you know they haven't expired?
Considerations For Sterility Test Methods When Working With CDMOs
Confirmation of microbial quality of drug products manufactured by CDMOs is a key component of product release. It is important to ensure that laboratory-specific method suitability testing is performed to ensure appropriate recovery of the presence of potential contaminants.
New Approaches For Drug Substance Freezing And Storage
The latest in drug substance-refrigeration technology gives the biopharmaceutical industry options for freezing and storing liquid DS. Here are some insights for optimizing setups based on application, facility, and budget.
FDA Adopts ICH Final Guidance On Bioanalytical Method Validation
The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.
AI/ML In Drug Discovery & Development: Potential And Challenges
Selecting the wrong target molecule or focusing on the wrong area of investigation can cause major delays and waste valuable time and resources. Artificial intelligence (AI) and machine learning (ML) can help drug discovery researchers minimize these missteps in a few key ways.
Calculating The Probability Of Passing The USP Dissolution Test
Dissolution tests are performed during drug manufacturing to ensure that the drug product meets the standards specified in the United States Pharmacopoeia (USP). This article calculates the probability of passing the USP dissolution test using Microsoft Excel, and it can be modified for any combination of Q, mean, and standard deviations.
FDA Seeks Comment On Delaying, Denying, Limiting, Refusing Inspections
The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.
PHARMA ONLINE WHITE PAPERS
Hot Melt Extrusion: Improving Solubility Of Poorly Soluble Compounds
As you create your hot-melt extrusion (HME) strategy to manufacture amorphous solid dispersions (ASDs), there are several considerations to ensure your plan is flexible, robust, and comprehensive.
The Importance And Role Of Data Integrity In The Life Science Industry1/6/2023
Data integrity is critical to ensure end products meet quality standards. Learn about data integrity, the importance of data governance, and key steps to getting started with data governance.
Pharma Analysis & Quality Control: Trends From The Rapid Pharma Evolution4/4/2022
We look into how the pharma analysis & QC community envisions future trends and explore if the challenges faced by your peers are the same as yours.
An Analysis Of Acceptable Particle Losses In Tubing2/1/2022
This paper addresses the various forces, the losses, and what are the acceptable results to allow for a better understanding what is acceptable particle loss in tubing.
Computer System Validation (CSV) To Computer Software Assurance (CSA)1/24/2023
Learn about the shift from Computer System Validation (CSV) to Computer Software Assurance (CSA) and the intent of this transition in approach to validation in the life science industry.
Sophisticated Formulation Approaches For Insoluble Drug Candidates1/24/2022
A sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
In pharmaceuticals, working effectively with contract development and manufacturing organizations (CDMOs) is an art as well as a science. Our latest e-book provides tips in selecting and working with a CDMO to accelerate the timeline for your drug development program through commercial manufacturing.More Content Collections