Step-by-Step Guide to Film Uniformity Validation in Oral Disintegrating Strips 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 Film Uniformity in Oral Disintegrating Strips
Oral disintegrating strips (ODS) provide a convenient and rapid dosage form, demanding precise manufacturing controls to achieve product uniformity and performance. Film uniformity validation is crucial because uneven films can lead to inconsistent drug content, dissolution profiles, and ultimately impact patient safety and efficacy. This process validation step confirms that the manufacturing control strategy consistently produces films meeting predefined quality standards.
Role of Film Uniformity Validation in cGMP and Batch Consistency
Adherence to current Good Manufacturing Practices (cGMP) requires robust validation to ensure reproducibility and compliance throughout production. Film uniformity validation plays a critical role in demonstrating control over variability sources such as coating thickness, drying parameters, and solution homogeneity. A validated process assures regulatory bodies and patients that each batch meets Quality Target Product Profile (QTPP) criteria, reducing release failures and maintaining therapeutic consistency.
Defining Quality Target Product Profile (QTPP) for Oral Disintegrating Strips
Before initiating validation, define the QTPP with objectives related to film uniformity. Essential attributes include uniform thickness, consistent drug load per unit area, rapid disintegration time, and satisfactory mechanical properties. These criteria steer the validation boundaries and acceptance criteria. For oral disintegrating strips, the QTPP emphasizes rapid film dissolution and dose precision, both of which are impacted by uniformity across the entire film matrix.
Desired Attributes in Film Uniformity
Uniformity in oral disintegrating strips encompasses multiple dimensions: thickness uniformity, weight uniformity, and drug content uniformity per unit area. Each attribute affects the strip’s physical integrity, drug availability, and patient compliance. The desired attributes are:
- Thickness uniformity: Consistency across the film prevents dose variability.
- Weight uniformity: Ensures each strip contains the intended amount of formulation.
- Drug content uniformity: Critical for meeting potency and therapeutic effect requirements.
- Mechanical uniformity: Adequate tensile strength and flexibility to avoid breakage during handling.
Impact of Film Uniformity on QTPP and Patient Outcomes
Non-uniform films can result in substantial variation in drug load per strip, leading to under or overdosing. This inconsistency compromises safety and efficacy, posing regulatory and clinical risks. Uniform films ensure consistent bioavailability, predictable disintegration time, and optimal patient acceptance. Validating film uniformity is thus integral to achieving the overall QTPP and meeting patient-centric performance attributes.
Identification and Control of Critical Quality Attributes (CQAs)
Within film uniformity validation, certain CQAs must be tightly monitored and controlled:
- Coating thickness: Typically measured by micrometer or non-destructive optical methods to detect thickness variability.
- Weight per unit area: Analyzed by cutting representative samples and weighing to verify dosing consistency.
- Drug content uniformity: Quantified using validated analytical methods such as HPLC or UV spectroscopy on multiple samples across the film.
- Disintegration time: Ensures compliance with defined rapid dissolution profiles.
- Mechanical properties: Tensile strength, folding endurance, and elasticity measured to confirm physical robustness.
Each CQA has established acceptance criteria aligned with regulatory guidelines and product specifications. Statistical analysis of CQA data across production batches confirms control and uniformity.
Key Properties and Parameters to Monitor During Validation
Successful film uniformity validation hinges on identifying critical process parameters (CPPs) and material attributes impacting the CQAs. Essential properties include:
- Viscosity of film-forming solution: Directly influences coating behavior and uniformity.
- Coating speed and spreader settings: Must be optimized for even application and uniform thickness.
- Drying temperature and time: Affect solvent evaporation rate and film integrity.
- Environmental conditions: Temperature and humidity in the manufacturing area can change solution rheology and drying.
- Raw material consistency: Source variability in polymers, plasticizers, and active pharmaceutical ingredients (APIs) impacts film formation and uniformity.
Regular monitoring and control of these parameters during process validation confirm that the manufacturing process is robust and capable of consistently producing uniform films.
Comprehensive Film Uniformity Validation in Oral Disintegrating Strips 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.
Critical Quality Attributes (CQAs) of Film Uniformity
Identification and control of CQAs are paramount to ensure the final product meets therapeutic efficacy and safety profiles. Key CQAs for film uniformity include:
- Film Thickness: Uniform thickness ensures consistent dose and mechanical strength.
- Weight Variation: Consistent weight per unit area correlates with content uniformity and strip performance.
- Drug Content Uniformity: Measured as drug content per unit area, critical for dose accuracy.
- Mechanical Properties: Tensile strength and flexibility to withstand handling without breakage.
- Disintegration Time: Rapid and reproducible disintegration aligns with the QTPP.
Key Properties Influencing Film Uniformity
Understanding and controlling the following parameters is essential to achieve desired uniformity:
- Coating Solution Viscosity and Rheology: Impacts spreadability and thickness control on substrates.
- Coating Speed and Coating Thickness Settings: Critical process parameters directly related to film uniformity.
- Drying Temperature and Time: Influences solvent evaporation rate and minimizes unevenness or defects.
- Mixing Homogeneity: Ensures even distribution of active pharmaceutical ingredient (API) and excipients.
- Substrate Quality and Surface Treatment: Uniform substrate surface enhances coating adherence and consistency.
Impact of Film Uniformity on QTPP Attributes
Variations in film thickness or drug distribution directly affect critical QTPP attributes such as dose accuracy and disintegration time. Thicker regions may lead to delayed disintegration or slow drug release, while thinner areas risk sub-therapeutic dosing or compromised mechanical strength. Uniform film properties ensure dose reproducibility, patient acceptability, and therapeutic efficacy, all essential for meeting regulatory and quality expectations.
Critical Quality Attributes (CQAs) Related to Film Uniformity
The following CQAs should be carefully monitored during film uniformity validation to ensure consistent performance:
- Thickness Uniformity: Measured along different sections of the film to confirm consistent layering.
- Weight Variation: Ensures uniform distribution of polymer and active ingredients.
- Drug Content Uniformity: Confirms consistent active pharmaceutical ingredient (API) concentration per unit area.
- Mechanical Properties: Tensile strength and flexibility to withstand handling.
- Disintegration Time: Rapid breakup in the oral cavity, aligned with product specifications.
Key Properties and Analytical Methods to Assess Film Uniformity
For thorough validation, standardized analytical techniques must be adopted to evaluate film uniformity and related quality attributes effectively:
- Thickness Measurement: Utilize micrometers or non-contact thickness gauges systematically at multiple points.
- Weight Testing: Collect representative film samples, accurately weigh, and calculate variance.
- Content Uniformity Testing: Employ validated analytical methods such as HPLC or UV spectroscopy after film dissolution to quantify API.
- Mechanical Testing: Apply tensile testing instruments to assess strength and flexibility parameters.
- Disintegration Testing: Use pharmacopoeial or custom methods tailored for orally disintegrating films to ensure consistent in-mouth performance.
Introduction to Film Uniformity Validation in Oral Disintegrating Strips Manufacturing
Film uniformity validation is a critical process in the manufacturing of oral disintegrating strips (ODS). Ensuring consistent thickness, weight, and active pharmaceutical ingredient (API) distribution in the film matrix directly impacts product performance, patient compliance, and regulatory compliance. This guide provides a detailed, step-by-step instructional approach to designing, executing, and evaluating film uniformity validation tailored for pharmaceutical ODS manufacturing.
Risk Assessment and Failure Mode Effect Analysis (FMEA)
Begin by conducting a comprehensive risk assessment focusing on the film formation and coating process. Implement an FMEA to identify potential failure modes affecting film uniformity.
- Identify Failure Points: Variability in polymer solution viscosity, improper drying temperature, inconsistent coating thickness, API sedimentation, and non-homogenous mixing.
- Assess Severity: Rank the impact of each failure on product quality and patient safety. For example, uneven API distribution may cause dose variability, rated as high severity.
- Determine Occurrence: Estimate the frequency of each failure during manufacturing, referencing historical data where available.
- Assess Detectability: Evaluate current methods for detecting each failure during in-process monitoring and release testing.
- Prioritize Risks: Use Risk Priority Numbers (RPNs) derived from severity, occurrence, and detectability to prioritize areas requiring enhanced controls.
Define Critical Process Parameters (CPPs)
Use the outcomes of the FMEA to identify and select CPPs that significantly influence film uniformity.
- Coating Thickness: Controlled by coating die gap and substrate speed.
- Drying Conditions: Temperature and airflow rate to ensure uniform solvent evaporation.
- Polymer Solution Viscosity: Critical for uniform spreading and film formation.
- Coating Speed: Influences film thickness and uniformity.
- Mixing Homogeneity: Affecting API distribution within the polymer solution.
Experimental Design (DoE) for Process Parameter Optimization
Conduct a well-structured DOE to statistically evaluate the effect of CPPs on film uniformity parameters.
- Select Factors and Levels: Choose relevant CPPs and define operational ranges based on development data.
- Choose Experimental Design: Utilize factorial or response surface methodology designs to explore process interactions efficiently.
- Define Responses: Measure film thickness uniformity, weight variation, and API content uniformity.
- Conduct Trials: Execute experiments per DOE matrix, ensuring robust data collection and analysis.
- Analyze Data: Use statistical software to identify significant factors and their optimal set points.
Control Strategy Development
Translate DOE findings and risk prioritization into a comprehensive control strategy to maintain film uniformity during routine manufacturing.
- Set Acceptable Ranges: Define specification limits for API content uniformity (e.g., ±5% of label claim), film thickness (e.g., ±10% nominal thickness), and weight variation.
- Establish In-Process Monitoring: Implement real-time or rapid assessment techniques such as near-infrared spectroscopy (NIRS) or inline thickness gauges.
- Control Critical Process Parameters: Establish SOPs for polymer solution preparation, coating settings, and drying protocols to maintain CPPs within defined ranges.
- Quality Attributes Monitoring: Set periodic sampling plans to test API distribution, moisture content, and mechanical properties of coated films.
Process Flow and Stepwise Workflow
Outline the manufacturing process flow emphasizing points critical to film uniformity:
- Polymer Solution Preparation: Accurately weigh and mix polymer, plasticizers, API, and excipients. Validate homogeneity via analytical sampling.
- Coating Solution Preparation Inspection: Measure viscosity and ensure compliance with target ranges.
- Film Casting/Coating: Set coating parameters according to CPPs and monitor thickness with inline gauges.
- Drying Stage: Control drying temperature and airflow for consistent solvent removal and film formation.
- Film Collection and Cutting: Monitor and record film weight and thickness post-drying.
- Secondary Processing: Incorporate any lamination or printing steps, ensuring these do not compromise film uniformity.
Sampling and Decision Points
Define sampling strategies and product review checkpoints tailored to film uniformity:
- Raw Materials: Sample polymer and API batches for identity, potency, and uniformity.
- In-Process Samples: Take periodic film samples at different coating stages, measuring thickness and weight uniformity.
- API Content Uniformity Sampling: Collect multiple film segments from different locations across the web after drying and cutting.
- Decision Rules: If sample results fall outside acceptable ranges, initiate predetermined corrective actions such as process adjustments or batch rejection.
Process Performance Qualification (PPQ)
Design and execute PPQ batches to confirm the validated process reliably produces uniform films meeting all quality attributes.
- Number of Batches: Manufacture at least three consecutive batches under commercial conditions.
- Data Collection: Capture comprehensive process data on CPPs and CQAs, including film thickness, weight, and API assay.
- Evaluation Criteria: Confirm all batches meet acceptance criteria for uniformity and other relevant specifications.
- Trend Analysis: Perform statistical analysis to demonstrate process stability and capability.
- Deviation Management: Document and investigate any deviations or OOS results with CAPA implementation as necessary.
Protocol Design and Documentation
Develop a detailed validation protocol incorporating all critical elements:
- Objective and Scope: Clearly define the intent and limits of film uniformity validation.
- Roles and Responsibilities: Assign qualified personnel for execution and review.
- Procedures: Include stepwise instructions for film preparation, sampling, measurement techniques, and data recording.
- Acceptance Criteria: Specify numeric limits for uniformity attributes based on regulatory and product specifications.
- Statistical Analysis Plan: Define methods and metrics for data evaluation.
- Reporting: Outline the format and content for validation reports.
Batch Execution and Evaluation
Conduct validation batches strictly following the approved protocol:
- Pre-Run Checks: Verify equipment calibration, raw material readiness, and process parameter settings.
- Execution: Perform manufacturing and sampling as per the process flow and sampling plan.
- Data Recording: Document all critical measurements, observations, and deviations in batch records.
- Post-Run Evaluation: Perform statistical analysis comparing process data against validated acceptance criteria.
- Final Report: Compile findings, confirm process robustness and uniformity, and provide recommendations for routine monitoring and re-validation triggers.
Conclusion
Film uniformity validation in oral disintegrating strips manufacturing demands rigorous risk assessment, controlled process parameters, systematic DOE, and comprehensive process qualification. Establishing a robust control strategy and carefully structured validation protocol ensures that film attributes consistently meet predefined specifications, assuring product quality and patient safety. Ongoing monitoring post-validation maintains process integrity throughout commercial manufacturing.
Control Strategy Development
Establish a robust control strategy to maintain film uniformity within acceptable limits and ensure process consistency.
- In-Process Controls: Implement real-time monitoring of coating thickness using inline thickness gauges or non-contact sensors to promptly detect deviations.
- Environmental Controls: Maintain strict control over drying temperature and humidity in the process environment to prevent variability in film formation.
- Equipment Controls: Regular calibration and maintenance of coating and drying equipment to ensure parameter stability.
- Raw Material Controls: Define and monitor raw material attributes such as polymer viscosity and API particle size to reduce upstream variability.
Establishing Acceptable Ranges and Specifications
Define objective acceptance criteria for film uniformity parameters based on clinical relevance and regulatory expectations.
- Film Thickness: Specify permissible limits (e.g., ±5% of target thickness) to ensure consistent disintegration time and dosage delivery.
- Weight Uniformity: Set batch-to-batch weight variation limits aligned with pharmacopeial guidelines.
- API Content Uniformity: Apply strict acceptance criteria (e.g., 85-115% of label claim per strip) verified through validated analytical methods.
- Physical Attributes: Define limits for visual defects, surface texture, and flexibility.
Process Flow and Stepwise Validation Workflow
Outline the detailed operational flow and sample collection points to systematically validate film uniformity.
- Preparation: Prepare polymer solution and API blend ensuring homogeneity as per validated mixing procedures.
- Coating: Apply the polymer solution onto the substrate using controlled coating parameters per the DoE results.
- Drying: Dry the coated film under precisely controlled temperature and airflow conditions.
- Primary Sampling: Collect film samples at initial, mid, and end points of each batch coating run.
- Secondary Sampling: Additional random sampling after film cutting into strips to verify weight and content uniformity.
- Testing: Conduct thickness measurement, weight determination, and API assay on collected samples.
- Data Recording: Record all process parameters and analytical results systematically for batch evaluation.
Protocol Design for Process Performance Qualification (PPQ)
Develop a comprehensive PPQ protocol to validate the film uniformity under full commercial production conditions.
- Batch Size: Define representative commercial batch sizes for validation runs.
- Number of Batches: Typically, three consecutive successful batches are required for PPQ.
- Sampling Plan: Detail frequency and location of samples along the length and width of the film.
- Acceptance Criteria: Incorporate established limits for film thickness, weight, and API uniformity.
- Data Analysis: Specify statistical methods for evaluating uniformity and process capability indices.
- Deviation Handling: Outline procedures for addressing non-conformances and predefined corrective actions.
Batch Execution and Evaluation
Execute PPQ batches adhering strictly to the validated process parameters and protocol.
- Perform continuous in-process monitoring and sample collection per established control strategy.
- Analyze collected samples immediately post-production for compliance with uniformity standards.
- Compile batch records including process parameters, monitoring data, and analytical results.
- Perform statistical analysis to confirm consistent process performance and product quality.
- Document findings and deviations, if any, including root cause analysis and corrective actions.
- Upon successful completion and approval, authorize routine manufacturing release and regulatory submission.
Introduction to Film Uniformity Validation in Oral Disintegrating Strips Manufacturing
Film uniformity validation is a critical component in the process validation of oral disintegrating strips (ODS). Ensuring consistent thickness and dose uniformity across strips directly impacts product efficacy, safety, and regulatory compliance. This validation aims to establish robust control through measuring and documenting uniformity parameters that meet predefined acceptance criteria.
Before initiating film uniformity validation, confirm that all manufacturing equipment has undergone successful qualification (IQ/OQ/PQ). Process equipment must function within specified parameters to reliably produce uniform films. This article guides pharmaceutical manufacturing professionals through stepwise execution, verification, documentation, and ongoing monitoring of film uniformity validation for oral disintegrating strips.
Define Acceptance Criteria and Validation Protocol
Begin by establishing clear acceptance criteria for film uniformity, generally aligned with pharmacopeial standards and product specifications:
- Uniform thickness within ±10% of target thickness
- Active pharmaceutical ingredient (API) content uniformity within 85%–115% of label claim per strip
- Relative Standard Deviation (RSD) ≤ 5% for thickness and API assay
Prepare a detailed validation protocol that includes:
- Objective and scope of film uniformity validation
- Description of sampling plan: number of batches (minimum 3), number of strips/sample points per batch
- Analytical methods for thickness and content uniformity
- Acceptance criteria and decision rules
- Documentation and reporting format
Sampling Plan and Sample Collection
Collect samples from at least three consecutive production batches to demonstrate process consistency. For each batch:
- Sample strips from multiple locations across the film length and width to account for potential variability caused by die geometry or coating uniformity.
- Recommended sampling involves at least 10 strips per batch, ideally from the beginning, middle, and end sections of the film reel.
- Clearly document sampling points with batch numbers, dates, and production parameters.
Analytical Testing for Film Thickness and Content Uniformity
Perform analytical testing utilizing validated methods:
- Thickness Measurement: Use a calibrated digital micrometer or optical thickness gauge. Measure thickness at predetermined points on each strip. Record values meticulously.
- Content Uniformity: Assay strips via validated analytical methods such as HPLC or UV spectrophotometry. Measure API concentration per strip in line with established protocols.
- Calculate mean, standard deviation (SD), and RSD for both thickness and content uniformity data per batch.
Data Analysis and Validation Result Tabulation
Document data in tabulated format for clarity and assessment:
| Batch No. | Thickness (µm) Mean ± SD | Thickness RSD (%) | API Content (% Label Claim) Mean ± SD | API Content RSD (%) | Acceptance |
|---|---|---|---|---|---|
| Batch 001 | 95 ± 4.5 | 4.7% | 101.5 ± 3.2 | 3.2% | Pass |
| Batch 002 | 97 ± 4.3 | 4.4% | 99.8 ± 4.1 | 4.1% | Pass |
| Batch 003 | 93 ± 4.1 | 4.4% | 100.7 ± 3.6 | 3.6% | Pass |
Comparative Summary and Compliance Assessment
Construct a comparative summary table that aggregates results across batches and evaluates conformity to acceptance criteria.
| Parameter | Target Value | Batch 001 | Batch 002 | Batch 003 | Overall Compliance |
|---|---|---|---|---|---|
| Thickness Mean (µm) | 95 ±10% | 95 | 97 | 93 | Pass |
| Thickness RSD (%) | ≤ 5% | 4.7 | 4.4 | 4.4 | Pass |
| API Content Mean (% label claim) | 85%–115% | 101.5 | 99.8 | 100.7 | Pass |
| API Content RSD (%) | ≤ 5% | 3.2 | 4.1 | 3.6 | Pass |
Validate that RSD values remain below 5% for both thickness and content uniformity, indicating a controlled and repeatable process. Confirm all results fall within predefined limits to comply with specifications.
Documentation and Validation Report Compilation
Compile a comprehensive validation report including:
- Protocol details
- Equipment qualifications and calibration records
- Raw data sheets and measurement records
- Validation result tabulation and comparative summary tables
- Graphical representation of uniformity trends (optional but recommended)
- Deviation and investigation records (if any)
- Conclusion and recommendation for routine monitoring
Continued Process Verification (CPV) and Routine Monitoring
After successful process validation, establish CPV to ensure ongoing control of film uniformity. Actions include:
- Implement in-process control (IPC) sampling with defined frequencies during routine production.
- Set control chart limits based on validation data to detect shifts/trends early.
- Document IPC sampling results systematically for accountability and review.
Integrate monitoring results into Annual Product Quality Review (APQR) for trend analysis, enabling timely corrective and preventive actions.
Annexure Templates for Film Uniformity Validation
For standardized documentation, include the following templates as annexures in the validation package:
Annexure I: Film Uniformity Validation Protocol Template
A structured protocol template covering objectives, sampling plan, acceptance criteria, and methods.
Annexure II: Sampling and Test Data Sheet
Standardized form for recording batch number, sampling location, thickness measurements, and API content assay values.
Annexure III: Validation Result Summary Table
Tabulate thickness and content uniformity data along with statistical parameters (mean, SD, RSD).
Annexure IV: Comparative Summary Table and Compliance Checklist
Summarize batch-wise compliance status against predefined limits and criteria.
Annexure V: Change Control and Deviation Report Template
Documentation template to record deviations or changes encountered during validation and resolution steps.
Conclusion
Film uniformity validation for oral disintegrating strips is essential for assuring consistent product quality and patient safety. Strict adherence to the defined stepwise approach, including thorough sampling, analytical verification, statistical evaluation, and robust documentation, forms the cornerstone of successful process validation. Establishing ongoing CPV through routine monitoring and trend analysis ensures sustained compliance throughout the product lifecycle.
Compilation and Validation Result Tabulation
Compile the analytical data of film thickness and API content uniformity from all sampled strips across three batches for result interpretation.
| Batch Number | Sample Location | Thickness (µm) | API Content (%) | Acceptable Range | Pass/Fail |
|---|---|---|---|---|---|
| Batch 1 | Beginning | 98 ± 7 | 102 ± 6 | ±10% Thickness; 85%-115% API |
Pass |
| Batch 1 | Middle | 100 ± 5 | 101 ± 5 | ±10% Thickness; 85%-115% API |
Pass |
| Batch 1 | End | 97 ± 6 | 99 ± 7 | ±10% Thickness; 85%-115% API |
Pass |
| Batch 2 | Beginning | 101 ± 5 | 104 ± 5 | ±10% Thickness; 85%-115% API |
Pass |
| Batch 2 | Middle | 99 ± 6 | 103 ± 6 | ±10% Thickness; 85%-115% API |
Pass |
| Batch 2 | End | 100 ± 7 | 101 ± 7 | ±10% Thickness; 85%-115% API |
Pass |
| Batch 3 | Beginning | 98 ± 6 | 100 ± 5 | ±10% Thickness; 85%-115% API |
Pass |
| Batch 3 | Middle | 97 ± 5 | 99 ± 6 | ±10% Thickness; 85%-115% API |
Pass |
| Batch 3 | End | 99 ± 6 | 98 ± 7 | ±10% Thickness; 85%-115% API |
Pass |
Comparative Summary and Statistical Analysis
Analyze the compiled data to evaluate film uniformity performance using key statistical measures:
- Calculate mean, relative standard deviation (RSD), and range for thickness and API content per batch.
- Compare inter-batch variability to confirm process consistency.
- Ensure RSD values are within the ≤ 5% acceptance threshold to establish uniformity compliance.
| Parameter | Batch 1 | Batch 2 | Batch 3 | Acceptance Criteria |
|---|---|---|---|---|
| Mean Thickness (µm) | 98.3 | 100.0 | 98.0 | Within ±10% target |
| RSD Thickness (%) | 3.5 | 2.8 | 3.2 | ≤ 5% |
| Mean API Content (%) | 100.7 | 102.7 | 99.0 | 85%–115% |
| RSD API Content (%) | 3.9 | 3.1 | 3.5 | ≤ 5% |
Continuous Process Verification and Routine Monitoring
Implement ongoing monitoring post-validation to ensure sustained film uniformity quality:
- Define routine in-process checks for film thickness and API content at regular manufacturing intervals.
- Set alert and action limits consistent with validation acceptance criteria.
- Document all routine monitoring data in the continuous process verification (CPV) log.
- Establish trending analysis via Annual Product Quality Review (APQR) to detect shifts or drifts.
- Conduct periodic re-validation or investigation if out-of-specification (OOS) or trending anomalies occur.
Annexures
For thorough documentation and standardization, include the following templates within Annexures:
- Annexure I: Film Uniformity Validation Protocol Template
- Annexure II: Sampling Log with Batch and Location Details
- Annexure III: Analytical Test Result Report Template
- Annexure IV: Validation Result Summary and Statistical Analysis Sheet
- Annexure V: Routine Monitoring Log and CPV Chart Template