Continuous Process Verification Protocol
1. Introduction/Background:
This protocol outlines the Continuous Process Verification (CPV) strategy for the manufacturing process
of [Product Name] powder in bottles. CPV is a science and risk-based approach that provides ongoing
assurance of process performance throughout the product lifecycle. It aims to proactively identify and
control variability to ensure consistent product quality within the defined Critical Quality Attributes
(CQAs) and Critical Process Parameters (CPPs).
2. Objectives:
- To establish a system for ongoing monitoring and evaluation of the validated manufacturing process.
- To provide evidence that the process remains in a state of control and consistently produces product
meeting pre-defined quality attributes.
- To detect and investigate any process deviations or trends that may impact product quality.
- To facilitate continuous improvement of the manufacturing process.
3. Scope:
This protocol covers all manufacturing steps from raw material dispensing to final product packaging for
[Product Name] powder in bottles. This includes:
- Raw material dispensing and handling
- Blending/Mixing
- Filling into bottles
- Capping/Sealing
- Labeling
- Packaging
4. CPV Team:
The CPV team will consist of representatives from the following departments:
- Production
- Quality Assurance
- Quality Control
- Engineering/Technical Services
5. Process Description:
[Provide a detailed description of the manufacturing process, including all steps, equipment used, and
process flow. Include a process flow diagram.]
6. Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs):
[List all identified CQAs and their target ranges. List all identified CPPs and their operating ranges.
Provide justification for the selection of CQAs and CPPs, referencing relevant development studies and
risk assessments. This is crucial and should be well-defined.]
Example Table:
CQA Specs CPP Operating range
Blend Uniformity Blending time
Fill Weight Blending speed
Drying time and
Moisture content temperature
Assay
Microbial Count
7. Monitoring Plan:
Detail the monitoring plan, including what parameters will be monitored, how frequently. This should
address both CPPs and CQAs.
Example Table:
Monitoring
Monitoring Frequency
CQA Frequency CPP
Blend Uniformity Every batch Blending time Every X bottles
Fill Weight Every X bottles Blending speed
Every batch Drying time and
Moisture content temperature
Assay Every batch
Microbial Count Every X batches
8. Data Analysis and Trending:
- Data will be collected and analyzed using statistical process control (SPC) methods (e.g., control charts).
- Trends, shifts, and outliers will be investigated.
- Appropriate control limits will be established and periodically reviewed.
- Data analysis software will be used to facilitate data management and analysis.
9. Deviation Management:
- Any deviation from the defined CPP operating ranges or CQA specifications will be documented and
investigated according to the site's deviation management procedures.
- The impact of the deviation on product quality will be assessed.
- Corrective and Preventive Actions (CAPA) will be implemented to address the root cause of the
deviation and prevent recurrence.
10. Change Control:
- Any changes to the manufacturing process, equipment, materials, or control strategy will be managed
through the site's change control system.
- The impact of the change on product quality will be assessed.
- Revalidation or requalification may be required.
11. Acceptance Criteria:
The process will be considered to be in a state of control when:
- All CPPs are maintained within their specified operating ranges.
- All CQAs meet their defined specifications.
- Data exhibits stable trends within established control limits.
- Deviations are promptly investigated and addressed.
Report
1. Executive Summary:
This report summarizes the Continuous Process Verification (CPV) data for [Product Name]
powder in bottles for the period of ………., to ………….. The data indicates that the
manufacturing process remained generally in a state of control during this period, with all
Critical Quality Attributes (CQAs) meeting their pre-defined specifications. One minor deviation
was observed for fill weight, which was promptly investigated and addressed through corrective
action.
2. CPP and CQA Performance:
Process
Target Average Standard Number of
CPP/CQA Capability
Range/Specification Value Deviation Deviations
(Cpk)
Blending Speed
20-30 25.2 1.5 1.2 0
(RPM)
Blend
Uniformity ≤ 5% 2.8 0.7 1.3 0
(RSD%)
Fill Weight (g) 100 ± 5 100.2 2.1 1.0 1
Assay (%) 98-102 99.5 0.8 1.4 0
Moisture
≤3 2.1 0.2 1.5 0
Content (%)
3. Deviation Summary:
One deviation was recorded during this reporting period:
Deviation Number: 2024-001
Date of Deviation: February 15, 2024
Description: Fill weight of one bottle within a batch was measured at 94g, below the
lower specification limit of 95g.
Root Cause: Intermittent malfunction of the filling machine's nozzle.
Corrective Action: The filling machine nozzle was inspected and repaired. The affected
batch was quarantined and sampled more extensively. All other bottles in the batch met
specifications.
Preventive Action: Preventative maintenance schedule for the filling machine nozzles
was reviewed and enhanced.
4. Trending Analysis:
(Example, in addition should include charts)
Blending Speed: Blending speed remained consistent throughout the quarter, with no
significant trends observed. Control charts indicate the process is well within control
limits.
Fill Weight: While one deviation occurred, the overall fill weight data shows a stable
trend. Control charts are being monitored closely for any signs of drift. A slight upward
trend in average fill weight was noted and will be further investigated.
Blend Uniformity: Blend uniformity results consistently met specifications and show a
stable trend.
(Include actual control charts, histograms, or other relevant graphs here)
5. CAPA Effectiveness:
The CAPA implemented for the fill weight deviation (2024-001) appears to be effective. No
further fill weight deviations related to the nozzle malfunction have been observed since the
repair and preventative maintenance enhancements. The effectiveness of the preventive action
will continue to be monitored.
6. Recommendations:
Continue close monitoring of the fill weight process, particularly the slight upward trend
in average fill weight.
Review the effectiveness of the enhanced preventative maintenance schedule for the
filling machine nozzles.
