Process Validation

Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?

Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.

Pharma 4.0 envisions highly efficient automated processes, which could be continuous, batch, or a hybrid of these, driven by an integrated manufacturing control strategy.

Can an Irish analytics company and its CEO bring pharma closer to 21st-century practice?

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

The revised Akers-Agalloco aseptic risk assessment and mitigation method includes two sub-methods that can be used independently for risk assessment.

Instead of rigidly applying statistical tools, experts suggest that pharma embrace statistical thinking, but focus on reducing variability and adding value for patients.

Six years after the guidance, it’s time to change our quality assurance vocabulary.

The industry needs a single standard cleaning limit at 25 mg/m2.

The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.

Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.

FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.

Effective cleanroom disinfection programs require extensive testing and evaluation processes. A three-step process can help ensure that the cleanroom environment will satisfy regulatory requirements and be safe for biopharmaceutical manufacturing.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

The success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties. \

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

Experts discuss the key considerations in the development of an autoinjector.

This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.

The author discusses the collection and evaluation of data part of FDA’s definition of process validation.