Comprehensive Texture and Chewability Validation in Chewable Tablets Manufacturing
All equipment used in this process validation must be duly qualified and validated for its intended use and performance specifications. Equipment qualification (IQ/OQ/PQ) is assumed to be completed prior to this process validation.
Introduction to Texture and Chewability Validation
Texture and chewability are critical quality attributes in the manufacturing of chewable tablets. These factors directly influence patient acceptance, compliance, and overall therapeutic efficacy. Texture refers to the physical feel of the tablet in the mouth, including hardness, smoothness, and friability, while chewability relates to how easily the tablet breaks down under mastication without causing discomfort.
Validating these attributes during the manufacturing process ensures that the final product meets the predefined quality standards and performs consistently batch-to-batch. This validation is a fundamental component within the broader framework of process validation in pharmaceutical manufacturing, aimed at maintaining compliance with current Good Manufacturing Practices (cGMP).
Role of Texture and Chewability Validation in cGMP and Consistency
Within the cGMP framework, process validation is essential to demonstrate that manufacturing processes reliably produce products meeting predetermined quality criteria. For chewable tablets, texture and chewability form part of these criteria because they affect both the safety and efficacy of the dosage form.
Step 1: Define the critical areas impacting texture and chewability, such as raw material quality, granulation parameters, compression force, and excipient ratios.
Step 2: Establish control strategies to monitor these parameters, ensuring they stay within validated limits.
Step 3: Implement in-process testing frequently during pilot and commercial batches to detect any variations that could affect tablet texture.
Step 4: Use validated analytical techniques, including texture analyzers and sensory evaluation panels, to quantitatively and qualitatively assess the tablets’ chewability.
Ensuring consistency in these attributes reduces batch failures, enhances patient satisfaction, and supports regulatory compliance.
Quality Target Product Profile (QTPP) and Its Relevance
The Quality Target Product Profile (QTPP) for chewable tablets defines the desired quality characteristics to achieve safety and effectiveness. Texture and chewability are integral to the QTPP, as they influence ease of administration and dosing accuracy.
Step 1: Develop a QTPP with clear specifications for hardness, friability, disintegration time, and organoleptic properties.
Step 2: Align texture and chewability attributes with therapeutic goals and patient demographics—for example, pediatric or geriatric patients typically require softer tablets.
Step 3: Use the QTPP as a foundation to identify critical quality attributes (CQAs) related to texture that must be tightly controlled during manufacturing.
Desired Attributes of Chewable Tablets
To validate texture and chewability effectively, it is essential to understand the desired physical and sensory attributes:
- Soft yet stable texture: Tablets should resist breaking during handling but soften sufficiently for comfortable mastication.
- Uniform hardness: Consistent hardness values ensuring comparable chewing resistance across batches.
- Appropriate friability: Minimal tablet crumbling during packaging and transport while maintaining chewability.
- Acceptable mouthfeel: No gritty or sharp sensations to support patient compliance.
- Palatability: Taste masking and smooth texture to enhance ease of use, particularly for pediatric formulations.
Step 1: Define the acceptable numeric ranges for hardness and friability based on formulation and clinical data.
Step 2: Use sensory evaluation methods, including taste panels and mouthfeel scoring, to objectively assess chewability during development and validation phases.
Impact on Quality Target Product Profile (QTPP)
Texture and chewability have a direct bearing on critical parameters listed in the QTPP:
- Dosage accuracy: Proper chewability ensures uniform breakdown and bioavailability.
- Patient adherence: Poor texture may lead to aversion and non-compliance.
- Stability: Optimal texture helps maintain tablet integrity throughout shelf life.
Step 1: Integrate tests measuring texture attributes into routine quality control to monitor batch conformity with QTPP.
Step 2: Adjust formulation or process parameters in response to deviations to prevent drift from the QTPP requirements.
Critical Quality Attributes (CQAs) for Texture and Chewability
Identification of relevant CQAs is vital for establishing a robust texture and chewability validation protocol. Key CQAs include:
- Tablet Hardness – Usually measured using a tablet hardness tester, hardness affects chew resistance and mechanical stability.
- Friability – Determined via friabilator testing, ensures tablets do not lose mass or crumble excessively during handling.
- Disintegration Time – Influences how rapidly the tablet breaks down during chewing and subsequent dissolution.
- Texture Profile Analysis (TPA) – Quantitative method using texture analyzers to simulate mastication forces and assess tablet deformation.
- Moisture Content – Moisture impacts tablet softness and shelf-life; controlled through validated drying processes and packaging.
Step 1: Develop validated test methods corresponding to each CQA to ensure reliable, reproducible measurements.
Step 2: Set specification limits for each attribute based on clinical and formulation data.
Step 3: Monitor these CQAs during process validation and commercial production to confirm consistent quality.
Key Properties for Measurement and Control
Measuring key physical properties accurately is paramount in texture and chewability validation. These properties include:
- Compression Force Consistency: Regulates the tablet hardness and density, impacting chewability.
- Particle Size Distribution: Affects texture by influencing tablet cohesion and smoothness.
- Excipients’ Functional Characteristics: Such as binder type and concentration, which modulate tablet firmness and chew resistance.
- Environmental Parameters: Temperature and humidity can alter tablet texture post-manufacturing.
Step 1: Implement in-process controls to monitor these properties continuously or at defined intervals.
Step 2: Employ statistical process control tools to detect trends and ensure parameters remain within validated ranges.
Step 3: Correlate these physical property measurements with observed texture and chewability results to refine control strategies.
Summary
Texture and chewability validation in chewable tablet manufacturing is a multi-faceted process essential for ensuring product quality. Through clearly defined QTPP, identification of CQAs, and rigorous measurement of critical physical properties, manufacturers can establish a validated, robust process that delivers consistent product performance. Adherence to cGMP and process validation protocols protects patient safety and supports regulatory compliance, ultimately enhancing therapeutic outcomes and patient satisfaction.
Quality Target Product Profile (QTPP) and Its Importance
The Quality Target Product Profile (QTPP) outlines the desired attributes and performance criteria of the chewable tablet, serving as a foundation for establishing critical quality attributes (CQAs). Key characteristics within the QTPP related to texture and chewability include tablet hardness, dissolution rate, mouthfeel, and disintegration time. Meeting the specified QTPP ensures the product achieves its intended therapeutic effect with high patient acceptability.
Step 1: Define texture and chewability parameters in the QTPP based on patient demographic and dosage requirements.
<Step 2: Align formulation development and process parameters to target these attributes effectively.
Step 3: Incorporate validated testing methods in the manufacturing process to continuously assure compliance with the QTPP.
Desired Attributes of Chewable Tablets
Chewable tablets must possess several sensory and mechanical properties to meet market and regulatory expectations. Desired attributes include:
- Optimal hardness: Sufficient to withstand handling but soft enough to be easily chewed.
- Smooth texture: Free from grittiness or chalky feel.
- Consistent friability: Low enough to avoid breaking during packaging but allowing proper disintegration upon chewing.
- Palatability: Pleasant taste and mouthfeel to improve patient compliance.
- Uniform chewability: Tablets should break down uniformly without leaving large residues.
Validating these properties requires both instrumental measurement and sensory evaluation, integrated into the process validation protocol.
Impact of Texture and Chewability on Critical Quality Attributes (CQAs)
Texture and chewability directly influence several CQAs, including uniformity of dosage, dissolution profile, and mechanical integrity. Variations in texture may lead to inconsistent dose release or patient discomfort, undermining therapeutic effectiveness.
Step 1: Identify texture-related CQAs such as hardness, friability, and disintegration time.
Step 2: Set acceptance criteria for these CQAs based on clinical and regulatory expectations.
Step 3: Monitor these attributes throughout process development and commercial manufacturing using validated methods.
Step 4: Investigate and control process variables that significantly impact texture and chewability to ensure batch-to-batch consistency.
Key Properties to Monitor During Validation
The following physical and mechanical properties are critical indicators of texture and chewability during process validation:
- Hardness testing: Using calibrated hardness testers to measure resistance to crushing.
- Friability assessment: Evaluating tablet weight loss after exposure to mechanical stress.
- Disintegration time: Measuring the time taken for a tablet to break down under simulated chewing conditions.
- Texture profile analysis (TPA): Employing texture analyzers to assess parameters such as chew firmness and cohesiveness.
- Sensory evaluation: Conducting controlled mouthfeel and chewability testing with trained panels.
Step 1: Establish validated SOPs for each test method.
Step 2: Perform validation runs to confirm that these properties fall within preset specifications.
Step 3: Incorporate real-time monitoring tools where feasible to detect deviations early and reduce product variability.
Risk Assessment and FMEA in Texture and Chewability Validation
Begin the validation process by conducting a comprehensive Failure Mode and Effects Analysis (FMEA) focused on chewable tablet texture and chewability attributes. Identify potential failure points such as improper granulation, inconsistent compression force, binder distribution variability, moisture content deviations, and storage conditions affecting tablet integrity.
For each failure mode, assess Severity, Occurrence, and Detectability on a standardized scale (e.g., 1 to 10). Severity relates to impact on patient compliance and product efficacy, Occurrence refers to the likelihood of occurrence in manufacturing, and Detectability concerns the probability of failure identification during in-process or final testing.
Calculate Risk Priority Numbers (RPN) by multiplying Severity, Occurrence, and Detectability scores. Prioritize high RPNs for immediate control measures, focusing on variables influencing tablet texture and chewability such as compression force, particle size distribution, and lubricant levels.
Design of Experiments (DoE) for Critical Parameter Identification
Design and implement a factorial Design of Experiments (DoE) to systematically investigate critical process parameters (CPPs) impacting chewable tablet texture and chewability. Key CPPs include:
- Compression force and dwell time
- Granulation moisture content
- Binder concentration and type
- Lubricant concentration
- Particle size distribution of excipients and active ingredients
Choose a suitable experimental design (e.g., full factorial or response surface methodology) to evaluate linear, quadratic, and interaction effects. Use chewability test data, texture profile analysis (TPA), and sensory panel results as response variables.
Critical Process Parameter (CPP) Selection and Control Strategy Development
From DoE results, identify CPPs that significantly affect texture parameters such as hardness, friability, chew resistance, and mouthfeel. Establish control limits based on statistical analysis and product performance requirements.
Develop a control strategy incorporating real-time monitoring of CPPs, process analytical technology (PAT) tools (e.g., near-infrared spectroscopy for moisture and content uniformity), and inline compression force sensors. Establish alarms and corrective actions for deviations.
Acceptable Ranges and Process Limits Definition
Define acceptable operational ranges for each CPP that ensure consistent chewable tablet texture and chewability characteristics. For example:
- Compression force: 10-15 kN, dependent on tablet formulation
- Moisture content: 2.0-3.5% w/w at granulation stage
- Binder concentration: within ±5% of the target value
Set these limits through a combination of empirical data from pilot batches and DoE outcomes to capture the Design Space.
Sampling and Decision Points for Texture and Chewability Monitoring
Integrate strategic sampling points at critical stages of manufacturing to monitor texture and chewability attributes:
- Granulation moisture content measurement post-granulation
- Hardness and friability testing on intermediate and final tablets
- Chewability testing using mechanical texture analyzers or trained sensory panels on representative samples
- In-process control data (e.g., compression force logs)
Implement acceptance criteria and decision trees to accept, rework, or reject batches based on conformance with texture and chewability specifications.
Process Flow and Stepwise Workflow Execution
Follow a clear, stepwise process to validate texture and chewability consistency in chewable tablet production:
- Pre-Process Setup: Complete equipment qualification (IQ/OQ/PQ). Ensure all devices related to compression, granulation, and drying are calibrated and validated for performance.
- Raw Material and Excipient Verification: Verify identity, particle size distribution, moisture content, and functionality, especially of binders and lubricants.
- Granulation: Control parameters including moisture addition, mixing time, and binder incorporation. Monitor granule size and moisture content.
- Drying: Validate drying profile to achieve target moisture content without compromising granule integrity.
- Compression: Set CPPs such as dwell time and compression force within determined acceptable ranges. Monitor tablet hardness and thickness inline if possible.
- Post-Compression Evaluation: Conduct friability and chewability testing on sample tablets immediately post-production and after stability time points.
- Packaging and Storage: Validate that packaging materials and conditions maintain tablet texture and chewability through shelf life.
Protocol Design for Process Performance Qualification (PPQ)
Design a comprehensive PPQ protocol including:
- Objectives clearly stating confirmation of texture and chewability consistency
- Scope addressing all process steps from granulation to packaging
- Defined acceptance criteria based on finished product specifications and DoE findings
- Detailed sampling plans and test methods, including mechanical texture analysis and sensory evaluation
- Data collection templates capturing CPPs, in-process parameters, and final product quality attributes
- Predefined corrective and preventive actions for out-of-specification (OOS) results
- Plan for statistical analysis correlating process parameters and product texture/chewability results
Batch Execution and Evaluation
During PPQ batch manufacturing, strictly adhere to validated process parameters and control strategies:
- Document and monitor CPPs in real time, ensuring operation within predefined limits.
- Collect samples for testing of tablet hardness, friability, and chewability at scheduled intervals.
- Perform mechanical texture profile analysis (e.g., hardness, cohesiveness, springiness) on representative tablets.
- Conduct chewability assessments using trained sensory panels or instrumental methods, comparing results to historical data and specifications.
- Compile all process and quality data for comprehensive evaluation post-batch completion.
- Analyze batch data statistically to confirm process consistency and control over texture and chewability attributes.
- Document deviations, investigate root causes, and implement corrective actions as needed.
Conclude PPQ by preparing a validation report summarizing findings, confirming that the chewable tablet manufacturing process consistently produces tablets meeting texture and chewability requirements, and defining any continuing verification activities.
Establishing Acceptable Ranges for Texture and Chewability Attributes
Define acceptance criteria for each texture and chewability attribute based on clinical considerations, regulatory guidelines, and historical batch data. Typical parameters and ranges include:
- Hardness: 4–8 kp, balancing mechanical strength with chewability
- Friability: Less than 1% weight loss to minimize tablet fragmentation
- Disintegration Time: Typically under 2 minutes in simulated saliva fluid
- Chew Resistance and Mouthfeel: Qualitative descriptors derived from sensory panels
Establish these ranges as in-specification criteria in the validation protocol to confirm batch compliance.
Process Flow and Stepwise Workflow for Texture and Chewability Validation
Outline the manufacturing process steps with critical checkpoints impacting texture and chewability:
- Raw Material Receipt and Testing: Ensure particle size, moisture limits, and excipient specifications are met.
- Granulation: Control moisture and binder levels to achieve optimal granule size distribution.
- Drying: Validate moisture removal to prevent tablet softening or brittleness.
- Milling and Blending: Achieve uniform particle size and content distribution.
- Compression: Monitor compression force, speed, and tablet weight variation.
- Coating (if applicable): Control coat thickness for mouthfeel consistency.
- Packaging and Storage: Validate conditions to maintain texture integrity.
Sampling and Decision Points during Validation
Define sampling plans at each critical stage:
- Granulation: Sample for moisture content, particle size, and binder uniformity.
- Tablet Compression: Sample tablets at start, middle, and end of batch runs for hardness, friability, and chewability tests.
- Finished Product: Conduct batch-level texture profile analysis and sensory testing.
Use statistical sampling plans (e.g., ANSI/ASQ Z1.4 Level II) and apply acceptance criteria for batch disposition decisions.
Process Performance Qualification (PPQ) and Protocol Design
Design the PPQ protocol to robustly demonstrate reproducibility of texture and chewability attributes under commercial manufacturing conditions:
- Execute minimum three consecutive batches under validated process parameters.
- Full characterization of texture via mechanical testing (hardness, friability) and sensory panel evaluation.
- Process monitoring data logging, including CPP tracking and PAT tool outputs.
- Deviation management and investigation procedures defined for any excursions beyond established limits.
Include acceptance criteria confirmation and statistical evaluation of batch-to-batch variability.
Batch Execution and Evaluation
Conduct batch manufacturing adhering strictly to the PPQ protocol steps and sampling schedule:
- Verify raw material conformity before batch initiation.
- Monitor CPPs continuously, maintaining process parameters within control limits.
- Collect texture and chewability test data at designated sampling points.
- Investigate and document any abnormalities or deviations immediately.
- Compile batch data for statistical analysis and final evaluation of compliance with specs.
Successful batches with all parameters within acceptance criteria confirm validation of texture and chewability in the chewable tablet manufacturing process.
Introduction to Texture and Chewability Validation in Chewable Tablets Manufacturing
Texture and chewability are critical quality attributes (CQAs) for chewable tablets, directly impacting patient compliance and product performance. The validation of these attributes ensures that the manufacturing process consistently produces tablets with the desired mechanical and sensory characteristics. This procedural guide outlines a systematic approach to validate texture and chewability in chewable tablets, focusing on equipment qualification, sampling, testing methods, acceptance criteria, and documentation protocols.
Preparation and Preliminary Activities
1.1 Confirm that all manufacturing and analytical equipment related to texture and chewability testing are fully qualified with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) completed.
1.2 Define and document the process parameters associated with tablet texture and chewability, including tablet hardness, friability, and deformation characteristics.
1.3 Develop a validation protocol specifying the documentary requirements, batch selection criteria, testing methods, acceptance criteria, and sampling plans.
Selection of Batches and Sampling Plan
2.1 Select a minimum of three consecutive commercial-scale batches for validation, ensuring they are manufactured under standard operating conditions.
2.2 From each batch, randomly select samples from three different time points—beginning, middle, and end of the production run—to verify process consistency and stability of texture attributes.
2.3 The sample size per batch should be statistically justified, commonly a minimum of 30 units per time point for hardness and chewability assessment.
Testing Methods and Instrumentation
3.1 Utilize calibrated texture analyzers equipped with appropriate probes to assess hardness, deformation load, and chewability profiles. Ensure calibration records are maintained.
3.2 Perform manual or automated friability testing according to compendial methods to evaluate tablet robustness.
3.3 Record chewability testing results based on sensory panel evaluations or instrumental texture profiling using standardized scales or algorithms for quantifying chew resistance and disintegration during mastication simulation.
Validation Execution and Data Collection
4.1 Conduct texture testing for all sampled tablets under controlled environmental conditions to limit variability.
4.2 Document raw data in the laboratory notebooks or electronic data capture systems immediately upon testing.
4.3 For each batch, generate a summary report including average values, standard deviations, and coefficient of variation (CV) for hardness, friability percentage, and chewability scores.
Validation Result Tabulation
| Batch Number | Test Parameter | Average Value | Standard Deviation (SD) | Relative Standard Deviation (RSD %) | Compliance Status |
|---|---|---|---|---|---|
| Batch 1 | Hardness (kg/cm²) | 12.8 | 0.35 | 2.73% | Pass |
| Batch 1 | Friability (%) | 0.45 | 0.05 | 11.11% | Pass |
| Batch 1 | Chewability Score (Sensory) | 8.2 | 0.52 | 6.34% | Pass |
| Batch 2 | Hardness (kg/cm²) | 13.1 | 0.42 | 3.21% | Pass |
| Batch 2 | Friability (%) | 0.48 | 0.06 | 12.50% | Pass |
| Batch 2 | Chewability Score (Sensory) | 8.0 | 0.40 | 5.00% | Pass |
| Batch 3 | Hardness (kg/cm²) | 12.9 | 0.37 | 2.87% | Pass |
| Batch 3 | Friability (%) | 0.44 | 0.04 | 9.09% | Pass |
| Batch 3 | Chewability Score (Sensory) | 8.3 | 0.48 | 5.79% | Pass |
Comparative Summary and Compliance Analysis
| Test Parameter | Overall Average | Overall RSD (%) | Specified Acceptance Criteria | Compliance | Optimum Range |
|---|---|---|---|---|---|
| Hardness (kg/cm²) | 12.93 | 2.94% | 10–15 kg/cm² | Compliant | 12–14 |
| Friability (%) | 0.46 | 10.90% | Not more than 1.0% | Compliant | 0.3–0.6% |
| Chewability Score (Sensory) | 8.17 | 5.71% | Minimum score of 7 | Compliant | 7.5–9.0 |
Analysis: The relative standard deviations for all parameters are below 15%, indicating acceptable process consistency. All measured values fall within the predetermined acceptance criteria and optimum ranges, confirming robust control over texture and chewability attributes.
Continued Process Verification and Routine Monitoring
7.1 Implement routine in-process and release testing for texture and chewability attributes on every manufacturing batch.
7.2 Establish control charts and trending reports to monitor parameter shifts or drifts.
7.3 Investigate any out-of-specification (OOS) results promptly and document corrective actions thoroughly.
7.4 Utilize data from recurring routine tests to update Annual Product Quality Reviews (APQRs) and support continuous improvement initiatives.
Documentation and Annexure Templates
8.1 Prepare a comprehensive validation report aggregating protocol, raw data, tabulated results, statistical analysis, and conclusions.
8.2 Maintain detailed records of sensory panel evaluations, equipment calibration certificates, and environmental conditions during testing.
8.3 Include standardized templates and annexures in the validation dossier to ensure traceability and regulatory compliance:
- Annexure I: Validation Protocol Template for Texture and Chewability
- Annexure II: Sampling Plan and Batch Selection Form
- Annexure III: Equipment Qualification and Calibration Records
- Annexure IV: Test Method Standard Operating Procedures (SOPs)
- Annexure V: Validation Results and Compliance Summary Form
Use these annexures as standardized documents during project execution to facilitate internal reviews and regulatory inspections.
Validation Result Tabulation and Data Analysis
5.1 Compile texture and chewability test results for all three batches in a Validation Result Tabulation Table, including hardness (N), friability (% weight loss), and chewability scores.
| Batch No. | Sampling Point | Hardness (N) | Friability (%) | Chewability Score |
|---|---|---|---|---|
| Batch 1 | Beginning | … | … | … |
| Batch 1 | Middle | … | … | … |
| Batch 1 | End | … | … | … |
| Batch 2 | Beginning | … | … | … |
| Batch 2 | Middle | … | … | … |
| Batch 2 | End | … | … | … |
| Batch 3 | Beginning | … | … | … |
| Batch 3 | Middle | … | … | … |
| Batch 3 | End | … | … | … |
5.2 Calculate the mean, standard deviation, and relative standard deviation (RSD) for hardness, friability, and chewability data across batches and sampling points to evaluate process variability and repeatability.
5.3 Compare results with pre-defined acceptance criteria to confirm compliance. Typical acceptance values:
– Hardness: within 5-8 kgf (~49-78 N),
– Friability: less than 1% weight loss,
– Chewability score: within established sensory panel range.
Comparative Summary and Optimum Analysis
6.1 Prepare a Comparative Summary Table contrasting results from the three validation batches to identify trends, outliers, or batch-to-batch variability.
| Parameter | Batch 1 (Mean ± SD) | Batch 2 (Mean ± SD) | Batch 3 (Mean ± SD) | Compliance Status | Optimum Range |
|---|---|---|---|---|---|
| Hardness (N) | … | … | … | Pass/Fail | 49–78 N |
| Friability (%) | … | … | … | Pass/Fail | <1% |
| Chewability Score | … | … | … | Pass/Fail | Defined sensory range |
6.2 Analyze RSD values to confirm process consistency; RSD ≤ 10% is typically considered acceptable for chewable tablet texture parameters.
6.3 Identify optimum process parameter ranges where texture and chewability consistently meet target profiles for enhanced patient acceptability.
Continued Process Verification and Routine Monitoring
7.1 Implement a Continued Process Verification (CPV) plan to systematically monitor texture and chewability during routine commercial manufacturing.
7.2 Define sampling frequency (e.g., first 3 lots per month) and key parameters to be tested—hardness, friability, and chewability—as part of routine quality control.
7.3 Document all results in CPV logs and trend charts to detect process drifts or deviations promptly.
7.4 Establish alert and action limits based on validation data to trigger investigations if parameter excursions occur.
Annual Product Quality Review (APQR) and Trending
8.1 Include texture and chewability data analysis in the APQR to evaluate long-term process performance and product quality consistency.
8.2 Perform trend analysis using statistical tools to identify gradual changes or shifts in texture attributes over time.
8.3 Correlate APQR findings with customer complaints or sensory feedback to support continuous improvement initiatives.
8.4 Update validation documentation and process controls as needed, supported by APQR outcomes.
Annexure I: Validation Protocol Template
Outline objectives, scope, batch selection, sampling methods, acceptance criteria, instrumentation, and responsibilities for texture and chewability validation.
Annexure II: Sampling Plan Template
Define sampling sizes, time points, and statistical justification for texture and chewability attribute evaluation.
Annexure III: Test Method SOP Template
Detail standardized procedures for hardness, friability, and chewability testing, including calibration and equipment operation steps.
Annexure IV: Validation Result Tabulation Template
Preformatted table to capture batch-wise texture and chewability testing outcomes for clear documentation and analysis.
Annexure V: CPV and Trending Log Template
Format to record ongoing monitoring data, trend charts, alerts, and corrective actions related to texture and chewability parameters.