- Title
- Evaluation of product x pre and post cpv implementation
- Creator
- Killian, Christopher Grant
- Subject
- Pharmaceutical industry
- Date Issued
- 2020
- Date
- 2020
- Type
- Thesis
- Type
- Masters
- Type
- MPharm
- Identifier
- http://hdl.handle.net/10948/46447
- Identifier
- vital:39577
- Description
- Purpose: Stage 3 of the pharmaceutical process validation lifecycle, is called continued process verification (CPV). CPV is the final stage of lifecycle management and is intended to provide ongoing assurance that during routine production that a process remains in a state of control. Since CPV is a relatively new focus area for regulators, many legacy products will not have undergone Stage 3 process validation. Therefore, an opportunity existed to review the impact and challenges of implementing CPV on a legacy product. Methodology: This study employed quantitative analysis to evaluate the impact of CPV on process stability and end product quality for Product X, a legacy product manufactured at a generics manufacturing facility. Initial Stage 3a CPV was used to review historical process data and identify special cause variation. Corrective and preventative actions were taken to address these statistical outliers and the impact of these process changes were evaluated in Stage 3b. Results: CPV implementation appeared to have an effect on process control, stability and capability for Product X. In Stage 3b, an increase in statistical outliers along with significant changes to process mean and standard deviation were seen for the critical process parameters, average mass and hardness. An improvement in process capability for the critical quality attributes, assay and dissolution, was also seen. Conclusion: The largest benefit of CPV implementation, especially for a legacy product, is the process knowledge gained. This provided opportunities for process improvement and ultimately benefited patient safety.
- Format
- xi, 128 leaves
- Format
- Publisher
- Nelson Mandela University
- Publisher
- Faculty of Health Sciences
- Language
- English
- Rights
- Nelson Mandela University
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NMU School of Medicinal Sciences
| Thumbnail | File | Description | Size | Format | |||
|---|---|---|---|---|---|---|---|
| View Details Download | SOURCE1 | Killian, CG 197108140 Treatise April 2020.pdf | 3 MB | Adobe Acrobat PDF | View Details Download |