Assignment 7: Method validation, calibrations, and verifications

1) (a) Why “Validation” is important for pharmaceutical manufacturing?

(b) What are the types of validation commonly used in pharma industry and what are the
benefits out of each of these types to the industry?

1. Importance of Validation in Pharmaceutical Manufacturing

(a) Why is Validation Important for Pharmaceutical Manufacturing?

Validation in pharmaceutical manufacturing is a systematic approach to ensure that processes,
equipment, and systems produce consistent and reliable results. Validation is critical because it:
1. Ensures Product Quality and Safety: Validation guarantees that the products meet
predetermined specifications and quality attributes. It ensures the safety, efficacy, and quality of
the pharmaceutical products, thereby protecting patient health.
2. Regulatory Compliance: Regulatory agencies like the FDA, EMA, and WHO require
validation as part of good manufacturing practices (GMP). Validation demonstrates compliance
with these regulatory standards, helping to avoid legal issues and penalties.
3. Risk Mitigation: By validating processes and systems, manufacturers can identify and mitigate
potential risks that could affect product quality. This proactive approach prevents costly recalls
and production downtime.
4. Efficiency and Cost-Effectiveness: Validation helps in optimizing processes, leading to more
efficient production. It reduces variability, waste, and rework, ultimately saving costs.
5. Market Confidence: A validated manufacturing process builds trust with regulators, healthcare
providers, and patients. It ensures that the products are consistently of high quality, enhancing
the company's reputation.

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(b) Types of Validation Commonly Used in the Pharma Industry and Their Benefits

1. Process Validation
Definition: Process validation confirms that the manufacturing process can consistently produce
a product that meets its predetermined specifications and quality attributes.
Benefits
1. Consistency: Ensures uniformity in product quality and performance.
2. Efficiency: Optimizes the manufacturing process, reducing waste and rework.
3. Compliance: Demonstrates adherence to regulatory requirements.

Example: A pharmaceutical company validates its tablet manufacturing process. During

validation, the company runs three consecutive batches under defined conditions and tests the
tablets for uniformity, dissolution rate, and potency. The consistent results confirm that the
process reliably produces high-quality tablets.

2. Equipment Validation (Qualification)

Definition: Equipment validation ensures that all equipment used in the manufacturing process
performs as intended.
Types: Installation Qualification (IQ), Operational Qualification (OQ), and Performance
Qualification (PQ).
Benefits
1. Reliability: Confirms that equipment operates correctly and consistently.
2. Safety Ensures equipment is safe to use and complies with safety standards.
3. Efficiency Reduces downtime and maintenance costs.

Example: A company installs a new high-performance liquid chromatography (HPLC) system.

IQ confirms that the equipment is installed correctly. OQ verifies that the HPLC operates within
specified parameters. PQ ensures that the HPLC produces reliable and accurate results during
routine use.

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3. Cleaning Validation
Definition: Cleaning validation verifies that the cleaning processes used to remove residues
from manufacturing equipment are effective.
Benefits
1. Product Safety: Prevents cross-contamination between batches.
2. Quality Assurance: Ensures no residual active ingredients or cleaning agents remain.
3. Regulatory Compliance: Meets regulatory standards for cleanliness.

Example: After producing a batch of antibiotics, the equipment is cleaned. Samples from
equipment surfaces are tested for residual antibiotics. Cleaning validation confirms that the
cleaning process effectively removes residues, ensuring that the next product batch is not
contaminated.

4. Analytical Method Validation

Definition: Analytical method validation ensures that the analytical procedures used to test
products are accurate, specific, and reproducible.
Benefits
1. Accuracy: Ensures test results are correct and reliable.
2. Reproducibility: Confirms that methods produce consistent results across different
laboratories and analysts.
3. Regulatory Acceptance: Complies with regulatory requirements for testing methods.

Example: A pharmaceutical company develops a new method to quantify the active ingredient in
a tablet. The method is validated by assessing parameters like accuracy, precision, specificity,
linearity, and robustness. Validation confirms that the method reliably quantifies the active
ingredient.

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5. Computer System Validation (CSV)
Definition: CSV ensures that computerized systems used in manufacturing and quality control
operate as intended and comply with regulatory requirements.
Benefits:
1. Data Integrity: Ensures that data generated and maintained by computer systems are
accurate and secure.
2. Regulatory Compliance: Meets regulatory requirements for electronic records and
signatures.
3. Operational Efficiency: Reduces errors and improves productivity by ensuring reliable
system performance.
Example: A company implements a new laboratory information management system (LIMS).
CSV involves testing the LIMS for functionality, security, data integrity, and performance.
Validation confirms that the LIMS accurately manages laboratory data and complies with
regulations like 21 CFR Part 11.

Conclusion
Validation is a cornerstone of pharmaceutical manufacturing, ensuring that products are
consistently high quality, safe, and effective. By employing various types of validation—process,
equipment, cleaning, analytical method, and computer system—pharmaceutical companies can
optimize their operations, comply with regulatory standards, and maintain market confidence.
Through rigorous validation practices, the industry ensures that patients receive reliable and
effective medications.

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Q2. Discuss about the main characteristics that should be considered in Analytical Method
Validation with a brief description of each characteristic and why “Analytical Method
Validation” is important to pharmaceutical industry

Introduction
Analytical method validation is a fundamental component of pharmaceutical quality assurance. It
ensures that the analytical methods used for testing drugs and their ingredients are accurate,
reliable, and reproducible. This process is critical in confirming that a drug product meets its
intended specifications for quality, safety, and efficacy. In the pharmaceutical industry,
adherence to validated analytical methods is essential for regulatory compliance, as it directly
impacts product approval and market entry.
Importance of Analytical Method Validation
Ensures Accuracy and Reliability
Accuracy and reliability are paramount in pharmaceutical testing because they ensure that the
test results truly reflect the properties of the drug substance or product. Without validated
methods, test results could be inaccurate, leading to potential risks for patients if the medication
is either ineffective or harmful.

Compliance with Regulatory Standards

Regulatory agencies like the FDA, EMA, and WHO mandate the validation of analytical
methods to ensure that pharmaceutical products meet strict quality standards. Compliance with
these regulations is necessary for product approval and market authorization. Analytical method
validation demonstrates that a company adheres to these regulatory requirements.

Enhances Data Integrity

Validated methods provide confidence that the data generated during drug testing is accurate and
reliable. This is essential for maintaining data integrity, which underpins the trustworthiness of
the entire drug development process. Data integrity is crucial for regulatory submissions and
audits.
Facilitates Reproducibility
Reproducibility is critical in ensuring that the results obtained by one laboratory can be
replicated by another. Validated analytical methods ensure that different analysts or laboratories
can obtain consistent results, which is essential for multi-site studies and global drug distribution.

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Optimizes Efficiency
By validating analytical methods, pharmaceutical companies can optimize their testing
processes, reducing the need for rework and minimizing errors. This leads to more efficient
operations and cost savings.

Main Characteristics of Analytical Method Validation

Analytical method validation involves several key characteristics, each addressing different
aspects of method performance. These characteristics ensure that the method is fit for its
intended purpose.

1. Accuracy
Description: Accuracy refers to the closeness of the test results to the true value. It is determined
by comparing the results obtained by the analytical method to a known reference or standard.
Importance: Accurate results are essential for determining the true concentration or potency of a
drug substance. Inaccurate results can lead to incorrect dosing, potentially causing harm to
patients or rendering the medication ineffective.
Example: In the validation of a method for determining the concentration of an active
pharmaceutical ingredient (API) in a tablet, accuracy is assessed by spiking the tablet matrix
with known quantities of the API and measuring the recovery rate.

2. Precision
Description: Precision refers to the closeness of repeated measurements under the same
conditions. It is typically evaluated in terms of repeatability and reproducibility.

Importance: High precision ensures that the method produces consistent results, which is critical
for quality control and regulatory compliance.

Example: Precision is evaluated by performing multiple measurements of the same sample under
identical conditions. The standard deviation or relative standard deviation (RSD) of the results is
calculated to assess precision.

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3. Specificity
Description: Specificity is the ability of the method to measure the intended analyte without
interference from other substances present in the sample.
Importance: Specificity is crucial for ensuring that the method can accurately identify and
quantify the target analyte in the presence of excipients, impurities, or degradation products.
Example: For a method intended to quantify a drug substance in a formulation, specificity is
demonstrated by showing that the method can distinguish the drug substance from other
components in the formulation.

4. Linearity
Description: Linearity refers to the method's ability to produce results that are directly
proportional to the concentration of the analyte within a given range.
Importance: Linearity is important for ensuring that the method can accurately quantify the
analyte across different concentrations, which is necessary for dose-response studies and quality
control.
Example: Linearity is assessed by analyzing samples with known concentrations of the analyte
and plotting the results against the concentrations. The correlation coefficient (R^2) of the
calibration curve indicates linearity.

5. Range
Description: The range is the interval between the upper and lower levels of the analyte that the
method can accurately and precisely measure.
Importance: The range defines the limits within which the method is effective, ensuring that it
can be used for various concentrations encountered during drug development and manufacturing.
Example: The range is established by demonstrating acceptable accuracy, precision, and linearity
across the specified interval, typically covering the expected concentrations in the product.

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6. Detection Limit (LOD)

Description: The detection limit is the lowest amount of analyte that the method can reliably
detect but not necessarily quantify.
Importance: LOD is important for ensuring that trace levels of impurities or contaminants can be
detected, which is crucial for safety and quality control.
Example: LOD is determined by analyzing samples with decreasing concentrations of the analyte
until the signal is distinguishable from the background noise.

7. Quantitation Limit (LOQ)

Description: The quantitation limit is the lowest amount of analyte that the method can
quantitatively measure with acceptable accuracy and precision.
Importance: LOQ is important for ensuring that the method can accurately quantify low levels of
the analyte, which is essential for potency assays and impurity profiling.
Example: LOQ is determined by analyzing samples with known concentrations of the analyte
and assessing the precision and accuracy at the lowest level that meets predefined criteria.

8. Robustness
Description: Robustness refers to the method's ability to remain unaffected by small, deliberate
variations in method parameters, indicating its reliability under varied conditions.
Importance: Robustness ensures that the method performs consistently under different
conditions, which is important for practical application in different laboratories and
environments.
Example: Robustness is evaluated by varying parameters such as temperature, pH, or solvent
composition and observing the effects on the method's performance.

9. System Suitability

Description: System suitability tests are used to verify that the analytical system is functioning
correctly before and during the analysis.

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Importance: These tests ensure that the system is capable of producing valid results, providing a
check on the overall performance of the analytical method and equipment.

Example: System suitability tests might include checks for parameters like resolution, tailing
factor, and theoretical plates in chromatography.

Integration and Application of Analytical Method Validation in the Pharmaceutical

Industry

Case Study: Validating a HPLC Method for API Quantification

Background: A pharmaceutical company is developing a new drug and needs to validate a high-
performance liquid chromatography (HPLC) method for quantifying the active pharmaceutical
ingredient (API) in tablet formulations.
Steps Involved:
1. Method Development: Initial method development includes selecting the appropriate column,
mobile phase, flow rate, and detection wavelength.
2. Accuracy: The method is tested by spiking the tablet matrix with known amounts of the API
and calculating the recovery rates. Results show an average recovery rate of 99%, indicating high
accuracy.
3. Precision: Repeatability is assessed by analyzing six replicate samples of the same
concentration. The relative standard deviation (RSD) is found to be 0.5%, demonstrating high
precision.
4. Specificity: The method is tested with blank samples, placebo samples (without API), and
spiked samples. The API peak is well-resolved from any other peaks, confirming specificity.
5. Linearity: Calibration standards ranging from 0.1 to 1.0 mg/mL are prepared and analyzed.
The calibration curve shows a linear relationship with an R^2 value of 0.999.
6. Range: The method is validated across the specified range, showing acceptable accuracy and
precision at all tested concentrations.
7. LOD and LOQ: The LOD is determined to be 0.01 mg/mL, and the LOQ is 0.03 mg/mL,
based on signal-to-noise ratios of 3:1 and 10:1, respectively.
8. Robustness: The method's robustness is tested by making deliberate changes to the mobile
phase composition and flow rate. The method remains reliable under these variations.
9. System Suitability: System suitability tests include checks for resolution, tailing factor, and
theoretical plates, all of which meet the predefined criteria.

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Outcome: The HPLC method is successfully validated and is used for routine quality control
testing of the new drug, ensuring that the API content in the tablets is accurate and consistent.

Impact of Analytical Method Validation

1. Regulatory Approval: The validated method is submitted as part of the regulatory dossier,
facilitating the approval process for the new drug.
2. Quality Assurance: Consistent and reliable testing ensures that each batch of tablets meets the
required quality standards, reducing the risk of product recalls.
3. Operational Efficiency: The robust method minimizes rework and retesting, improving overall
efficiency in the quality control laboratory.
4. Patient Safety: Accurate and reliable quantification of the API ensures that patients receive the
correct dosage, enhancing the drug's efficacy and safety.

Conclusion

Analytical method validation is a cornerstone of pharmaceutical quality assurance. By ensuring

that analytical methods are accurate, precise, specific, linear, robust, and reliable, pharmaceutical
companies can maintain high standards of product quality and safety. Validation not only meets
regulatory requirements but also enhances operational efficiency and data integrity. As
demonstrated in the case study, a validated method provides confidence in the analytical results,
supporting successful regulatory approval and ensuring that patients receive safe and effective
medications.

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Q3. 3) (a) Briefly describe what is meant by “Calibration”? (b) What are the main
objectives of Calibration? (c) Why it is important to have a regular calibration program for
equipment used in pharmaceutical manufacturing industry?

3. Calibration in the Pharmaceutical Manufacturing Industry

(a) What is Calibration?

‘Calibration’ in the context of pharmaceutical manufacturing refers to the process of comparing

the measurement device or instrument (such as analytical instruments, scales, meters, etc.)
against a standard reference of known accuracy. The goal is to ensure that the instrument
provides accurate and reliable measurements within specified tolerances.

(b) Main Objectives of Calibration

Calibration serves several critical objectives:

1. Ensuring Accuracy: Calibration verifies that instruments provide accurate measurements

consistent with known standards. This is crucial for maintaining product quality and safety in
pharmaceutical manufacturing.

2. Ensuring Reliability: Calibration ensures that instruments produce reliable results over time. It
helps identify and correct any deviations or inaccuracies before they affect product quality or
compliance.

3. Compliance: Many regulatory agencies, such as the FDA and EMA, require calibrated
instruments as part of Good Manufacturing Practices (GMP). Compliance with these standards is
essential for product approval and market acceptance.

4. Minimizing Risks: Proper calibration reduces the risk of producing out-of-specification

products or conducting inaccurate tests. It enhances overall process control and quality
assurance.

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 (c) Importance of Regular Calibration Program for Equipment in Pharmaceutical
Manufacturing

Regular calibration of equipment is crucial for several reasons:

1. Quality Assurance: Calibration ensures that equipment performs within specified accuracy
limits. This is critical for ensuring the quality and consistency of pharmaceutical products. For
example, in the production of medications, precise measurements of ingredients and process
parameters are essential to meet formulation specifications.

2. Regulatory Compliance: Regulatory agencies mandate that pharmaceutical manufacturers

maintain calibrated equipment to ensure the accuracy and reliability of manufacturing processes.
Non-compliance can lead to regulatory sanctions, including product recalls and legal penalties.

3. Risk Management: Regular calibration helps identify equipment drift or performance issues
early. Detecting and correcting these issues promptly minimizes the risk of producing defective
products or conducting inaccurate tests, thereby protecting patient safety and company
reputation.

4. Data Integrity: Calibrated equipment generates reliable data that is critical for decision-making
in pharmaceutical manufacturing. Accurate measurements support product quality assessments,
process optimization, and regulatory submissions.

5. Operational Efficiency: By maintaining calibrated equipment, pharmaceutical companies can

optimize production processes, reduce waste, and improve overall operational efficiency.
Reliable equipment performance reduces downtime and rework associated with out-of-
specification results.

Example Scenario: Importance of Calibration in Tablet Manufacturing

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Background: A pharmaceutical company manufactures tablets using a high-speed tablet press.
The company implements a regular calibration program for critical equipment, including the
tablet press.

Impact of Calibration
1. Ensuring Dosage Accuracy: The tablet press is calibrated to ensure that each tablet
contains the correct amount of active pharmaceutical ingredient (API). This accuracy is
crucial for patient safety and therapeutic effectiveness.
2. Meeting Regulatory Standards: Regulatory agencies require the tablet press to be
calibrated regularly to ensure compliance with GMP standards. Calibrated equipment
provides assurance that tablets meet quality and potency specifications.
3. Minimizing Production Risks: Calibration detects and corrects any deviations in tablet
weight or hardness promptly. This reduces the risk of producing out-of-specification
tablets and avoids costly rework or product recalls.
4. Enhancing Data Integrity: Calibrated equipment generates reliable production data,
supporting batch release decisions and regulatory submissions. Accurate data ensures that
the tablets meet required quality standards.

Conclusion
Calibration is a critical process in pharmaceutical manufacturing that ensures equipment
accuracy, reliability, and compliance with regulatory standards. By implementing a regular
calibration program, pharmaceutical companies can enhance product quality, maintain regulatory
compliance, and minimize production risks. Calibration supports data integrity, operational
efficiency, and ultimately, patient safety by ensuring that pharmaceutical products meet stringent
quality specifications.

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Q4. 4) (a) What is the importance of raw material testing in pharmaceutical manufacturing
industry? (b) What are the challenges faced by the industry in testing of raw materials for
pharmaceutical production?

(a) Importance of Raw Material Testing

Raw material testing plays a crucial role in ensuring the quality, safety, and efficacy of
pharmaceutical products.
1. Quality Assurance: Raw material testing verifies the identity, purity, and quality of incoming
materials used in pharmaceutical production. This ensures that only materials meeting specified
standards are used, thereby maintaining product consistency and performance.
2. Compliance with Standards: Regulatory authorities, such as the FDA and EMA, require
pharmaceutical manufacturers to conduct thorough testing of raw materials to ensure compliance
with Good Manufacturing Practices (GMP). Compliance with these standards is essential for
product approval and market acceptance.
3. Risk Mitigation: Testing helps identify potential contaminants, impurities, or deviations in raw
materials that could compromise product quality or safety. Early detection allows manufacturers
to take corrective actions to prevent issues during production.
4. Process Control: By establishing quality specifications and conducting routine testing,
manufacturers can control and monitor the entire production process more effectively. This
reduces variability and ensures consistent product quality.

5. Cost Efficiency: Effective raw material testing helps prevent production failures, rejections, or
recalls due to non-compliant materials. This reduces waste and associated costs, optimizing
overall manufacturing efficiency.

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(b) Challenges Faced by the Industry in Raw Material Testing for Pharmaceutical
Production

Despite its importance, raw material testing in the pharmaceutical industry presents several
challenges:
1. Availability of Qualified Suppliers: Ensuring a consistent supply of high-quality raw materials
from reliable suppliers can be challenging. Manufacturers must carefully qualify and audit
suppliers to ensure they meet stringent quality standards.
2. Complexity of Testing Requirements: Raw materials used in pharmaceutical production often
require complex testing protocols to verify identity, purity, potency, and microbiological safety.
Developing and validating these tests can be time-consuming and resource-intensive.
3. Analytical Method Validation: Validating analytical methods used for raw material testing is
crucial to ensure accurate and reliable results. Method validation requires expertise, specialized
equipment, and adherence to regulatory guidelines (e.g., ICH guidelines).
4. Sampling Variability: Ensuring representative sampling of raw materials can be challenging
due to variations in material properties, particle size distribution, and heterogeneity. Proper
sampling techniques are essential to obtain accurate test results.
5. Regulatory Compliance: Meeting regulatory requirements for raw material testing, including
pharmacopeial standards (e.g., USP, Ph. Eur.), can be demanding. Manufacturers must stay
updated with evolving regulations and ensure compliance throughout the testing process.
6. Time Constraints: Timely testing of raw materials is crucial to avoid delays in production
schedules. Laboratories must balance the need for rapid testing with the requirement for
thorough analysis to maintain product quality and safety.
7. Cost of Testing: The cost associated with raw material testing, including equipment,
personnel, and consumables, can be significant. Managing testing costs while ensuring thorough
analysis and compliance with standards is a continuous challenge.

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Example Scenario: Challenges in Testing Active Pharmaceutical Ingredients (APIs)

Background
A pharmaceutical company imports an active pharmaceutical ingredient (API) from an overseas
supplier for use in manufacturing tablets.
Challenges Faced
a) Supplier Qualification: Ensuring that the API supplier meets GMP standards and
provides consistent quality materials.
b) Identity Testing: Verifying the identity of the API using appropriate analytical
techniques, such as spectroscopy or chromatography.
c) Impurity Profiling: Detecting and quantifying impurities in the API, which requires
sensitive analytical methods and reference standards.
d) Microbiological Testing: Ensuring the API is free from microbial contamination through
microbiological testing, including sterility and endotoxin testing.
e) Compendial Compliance: Testing the API against pharmacopeial monographs (e.g., USP,
Ph. Eur.) to ensure compliance with specified standards.

Impact
Effective raw material testing ensures that the API meets quality specifications before use in
tablet manufacturing. It mitigates risks associated with potential impurities or contaminants,
ensuring the safety and efficacy of the final product.

Conclusion
Raw material testing is essential for maintaining the quality, safety, and efficacy of
pharmaceutical products. While it presents challenges such as supplier qualification, complex
testing requirements, and regulatory compliance, effective testing programs help mitigate risks
and ensure compliance with GMP standards. By addressing these challenges through robust
quality control measures and adherence to regulatory guidelines, pharmaceutical manufacturers
can uphold high standards of product quality and patient safety.

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