Testing Types
Method Validation & Verification Testing

Method Validation & Verification Testing

Scientifically rigorous method validation and verification studies to demonstrate analytical performance, regulatory compliance, and suitability for routine pharmaceutical testing.

Terms and Conditions

I. Confidentiality:

PLS Analytical ("PLSA") maintains strict confidentiality with its clients.

Formal Confidentiality agreements may be initiated by the client or by PLS Analytical.

II. Financial Information

Payment in advance is required for clients whose credit has not been established with PLSA.
Payment terms are “NET 15 days from receipt of the results”. Buyer agrees to pay all costs, including, but not limited to attorney and accounting fees and other expenses of collection resulting from any default by buyer in any of the terms of this contract.
Purchase orders or valid credit card information are REQUIRED. Orders submitted without this information may cause delays in testing.
For third party billing a signed purchase order must be received from the party paying for the service.
A surcharge of 50% or greater will be added for EXPRESS service. Express is subject to prior approval and availability.
Pricing is designed for single samples. Project discounts may be available. Quotations will be provided free of charge.
A minimum billing of $25.00 will be charged on all samples including those samples cancelled at the customer's request.
Clients that request Raw Data will have a copy sent to them electronically (at no charge) along with their report. There may be a surcharge for copies of the raw data and report when requested after initial sending is completed.
Additional charges may be assessed (e.g. hazardous samples, composite fee).
Shipping costs will be charged to clients that would like containers, coolers or ice packs returned.
Liability of PLSA is limited to an amount no greater than the amount invoiced.

III. Sample Submission:

Fill out the Sample Submission Form COMPLETELY, including product name, lot number, test, methods, and the amount of samples sent. Incomplete information may cause a delay in providing services.
All results will be reported by the method supplied and/or identified. If a limit is not supplied, we will default to associated compendia limits, or “Report Results” when compendial limits are not available.
All samples should be labelled with company name, product name and lot number. Samples received without a lot number will be sent back to the client for proper labeling. Hazardous Substances must be appropriately labeled for the protection of office and laboratory personnel.
- Shipping carton exterior must be labeled as to the hazard enclosed; caustic, cytotoxic, antineoplastic, explosive, corrosive, toxic, or carcinogenic, etc.
- Safety Data Sheet (SDS) must be provided for all Hazardous samples.
- Additional charges may be applied.
- Please place Sample Submission Form, SDS and any other correspondence submitted, in an envelope and place at the top of the box or affixed to the outside of the box. Failure to use the PLSA Submission Form for Analytical Services may delay results.

IV. Retention and Disposal:

Samples are retained for a period of 30 days after completion of analysis.
Special PRIOR arrangements must be made to return or retain samples under other conditions.
Unless alternate arrangements have been made, raw data will be retained for 6 years after final report date.

IMPORTANT

Turnaround Times:
- In calculating turnaround times, pending all appropriate documentation is in order; if the sample is received before 10 am then the day the sample is received is Day 1 otherwise it will be on the next business day.
- Standard TAT is 10 Business days.
- Express Service is subject to prior approval, availability and surcharges.
- For International orders, please allow sufficient time for samples to clear customs.
Please pack samples appropriately to prevent breakage.
Because transportation of materials to our facilities can have significant impact on the moisture content of client sample materials, PLS Analytical will not accept client-provided Loss on Drying/Moisture content results. When required for testing, the Loss on Drying/Moisture Content will be performed at PLS Analytical and will be billed to clients at a flat rate. Please contact our Customer Service Team for current associated costs.
If growth is obtained during microbial enrichment testing, a gram stain will be performed and billed to the client. Please contact our Customer Service Team for current associated costs.
For Questions regarding the above information please contact our Client Services Department at 732-698-5050.

I confirm that I have read and accept the terms and conditions.

Sample Submission Form

Submitter Information

Date

Company Name / Address

Contact Name

Billing

Send Invoice To

If differentSame as Report

Name and email for invoicing

Order References

PO Number*

Quote Number*

Turn Around Time

StandardRush

Express, needed byInclude Raw Data

Controlled substance

Yes No

Microbiology sample suitability

YesNo

Analytical sample: method verification required

YesNo

Special Instructions

Fill The Sample Columns

SAMPLE NAME	LOT # (ONE LOT PER LINE)	METHOD (MUST BE PROVIDED)	TEST REQUESTED (MUST BE PROVIDED)	SPECIFICATION (MUST BE PROVIDED)	QUANTITY

Required for Testing to Begin Customer Initials and Date

Method Validation

What is Method Validation?

Analytical method validation establishes that a test method consistently generates accurate, reliable, and reproducible results for its intended purpose. It demonstrates that an analytical procedure is scientifically suitable for evaluating the quality, identity, purity, strength, or performance of pharmaceutical materials and products.
Method validation is performed for newly developed analytical procedures, modified methods, and product-specific methods used throughout pharmaceutical development, manufacturing, stability studies, and quality control.

Method Validation Services

PLS Analytical provides comprehensive analytical method validation services for both client-provided methods and in-house developed analytical procedures across pharmaceutical drug substances, drug products, packaging materials, and medical devices.

For client-provided methods, we begin with a feasibility assessment to confirm successful implementation using qualified instrumentation and laboratory conditions. Based on the assessment and client requirements, a validation protocol is developed before executing studies in accordance with applicable ICH, USP, FDA, and client-specific guidelines.

For methods developed in-house, our scientists design, optimize, and validate analytical procedures to meet the intended application. Validation studies evaluate key performance characteristics including specificity, accuracy, precision, linearity, range, robustness, detection capability, and quantitation capability to demonstrate suitability for routine quality control and stability testing.

Our capabilities support validation of analytical methods for:

Assay
Related substances and impurity profiling
Nitrosamine impurities
Dissolution
Content and blend uniformity
Particle Size Distribution (PSD)
Residual solvents
Elemental impurities
Cleaning validation
Extractables and Leachables (E&L)
Preservatives and antioxidants
Identification testing
Residue analysis
Stability-indicating methods
Other chromatographic and spectroscopic analytical procedures

What is Method Verification?

Analytical method verification confirms that an established or compendial analytical procedure performs as intended under a specific laboratory’s operating conditions. Rather than validating a new method, verification demonstrates that an existing validated procedure can be successfully implemented using qualified instrumentation, trained analysts, and laboratory-specific systems.

Method verification is commonly performed for USP, EP, BP, and other compendial procedures, as well as validated client-provided methods, prior to routine quality control and regulatory testing.

Method Verification Services

PLS Analytical provides analytical method verification services for compendial and client-provided validated methods across pharmaceutical drug substances, drug products, packaging materials, and medical devices.

Each project begins with a feasibility assessment to confirm successful implementation using qualified instrumentation, reference standards, reagents, and laboratory conditions. Based on the assessment and project requirements, a verification protocol is developed and executed in accordance with USP 〈1226〉 and applicable client-specific requirements.

Verification studies are designed according to the intended use of the analytical procedure and may include evaluation of:

Specificity

Accuracy

Precision

Linearity (where applicable)

Range (where applicable)

Detection Limit (LOD)

Quantitation Limit (LOQ)

System suitability

Our verification capabilities support a broad range of analytical methods, including assay, impurity profiling, dissolution, content and blend uniformity, residual solvents, elemental impurities, nitrosamine impurities, extractables and leachables (E&L), cleaning verification, identification testing, preservatives, antioxidants, and other chromatographic and spectroscopic procedures.

Method Validation

What is Method Verification?

Method verification is commonly performed for USP, EP, BP, and other compendial procedures, as well as validated client-provided methods, prior to routine quality control and regulatory testing.

Method Verification Services

Verification studies are designed according to the intended use of the analytical procedure and may include evaluation of:

Specificity
Accuracy
Precision
Linearity (where applicable)
Range (where applicable)
Detection Limit (LOD)
Quantitation Limit (LOQ)
System suitability

Why it Matters

Reliable method validation and method verification are essential to ensure that analytical methods consistently generate accurate, precise, and reproducible results throughout the product lifecycle. Properly validated and verified methods provide confidence in analytical data, support regulatory compliance, facilitate successful method transfer, and help ensure the quality, safety, and efficacy of pharmaceutical products.

At PLS Analytical, our experienced scientists and well-trained analysts perform method validation and verification using qualified instrumentation, robust documentation practices, and a comprehensive quality review process. We prioritize client requirements, maintain clear communication throughout the project, and are committed to delivering high-quality results within agreed timelines. Our scientific expertise and customer-focused approach enable us to provide reliable analytical solutions that support product development, quality control, stability studies, and regulatory submissions.

Testing Services

Demonstrate analytical performance with confidence

PLS Analytical performs method validation and verification studies to support product development, routine quality control, technology transfer programs, stability studies, and regulatory submissions.

1. Analytical Method Validation

Analytical method validation evaluates the performance characteristics of newly developed, modified, and product-specific analytical procedures. Scientifically robust data supports regulatory submissions, product-specific methods, quality programs, and demonstrates fitness for intended use.

2. Method Verification Studies

Method verification studies evaluate the performance of compendial and previously validated analytical methods under laboratory-specific conditions. Scientifically robust data supports USP and pharmacopeial methods, technology transfer, routine implementation, and regulatory compliance.

Advantages

Built for reliable, regulatory-ready analytical performance

Method validation and verification studies provide documented evidence that analytical procedures generate accurate, reproducible, and scientifically defensible results.

Reliable Analytical Data

Validation and verification activities establish confidence in analytical performance, ensuring that testing results can support quality decisions, product release, and regulatory documentation.

Reduced Compliance Risk

Demonstrating method suitability helps minimize regulatory observations, data integrity concerns, analytical investigations, and quality-related delays.

Improved Lifecycle Performance

Well-characterized analytical methods support consistent performance throughout development, technology transfer, commercial manufacturing, and ongoing quality programs.

Regulatory Compliance

Method validation and verification studies support compliance with ICH Q2(R2), USP guidance USP <1225> Validation of Compendial Procedures, USP <1226> Verification of Compendial Procedures, FDA expectations, and global pharmaceutical quality standards. Documentation generated through these studies helps support regulatory submissions, inspections, audits, and lifecycle quality management.

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