Testing Types
Method Transfer Testing

Method Transfer Testing

Structured analytical method transfer studies to demonstrate method performance, reproducibility, and readiness across laboratories, manufacturing sites, and testing environments.

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

Overview

What is Analytical Method Transfer?

Analytical method transfer is the process of demonstrating that an analytical procedure can be successfully implemented in a different laboratory while maintaining consistent performance and data quality. At PLS Analytical, method transfer studies help manufacturers ensure analytical continuity across technology transfer programs, manufacturing sites, and contract testing laboratories.

What is Method Transfer Testing?

PLS Analytical performs structured method transfer studies to confirm that analytical procedures can be reproduced reliably within the receiving laboratory. Depending on the method and regulatory requirements, studies may include comparative testing, replicate sample analysis, co-validation activities, method verification, and protocol-driven performance assessments. These evaluations support assay methods, impurity testing, dissolution procedures, stability-indicating methods, microbiological testing, and other product-specific applications.

Why it Matters

Analytical methods often support quality decisions across multiple laboratories, manufacturing facilities, and contract testing organizations. Successful method transfer helps ensure consistent analytical performance when products move between development, commercial manufacturing, or external testing partners, reducing the risk of inconsistent results, release delays, and compliance challenges.

PLS Analytical delivers scientifically structured method transfer programs aligned with USP <1224>, FDA expectations, and global pharmaceutical quality systems, helping manufacturers support technology transfer activities, regulatory submissions, inspections, and long-term quality assurance.

Testing Services

Ensure analytical consistency across laboratories and manufacturing sites

PLS Analytical performs method transfer studies to support technology transfer programs, laboratory onboarding, manufacturing site changes, and commercial quality operations.

1. Comparative Method Transfer Studies

Comparative method transfer studies evaluate analytical performance between transferring and receiving laboratories through direct comparative testing. Scientifically robust data supports inter-laboratory transfers, commercial manufacturing programs, contract testing partnerships, and analytical continuity.

2. Method Verification Following Transfer

Method verification following transfer evaluates the performance of transferred analytical procedures within the receiving laboratory environment. Scientifically robust data supports USP and compendial methods, previously validated procedures, newly established testing laboratories, and routine implementation.

3. Technology Transfer Support

Technology transfer support evaluates the successful implementation of analytical procedures during development programs, manufacturing expansion, and commercial site transitions. Scientifically robust data supports site transfers, product commercialization, multi-site quality operations, regulatory compliance, and analytical continuity.

Advantages

Built for reliable, seamless analytical transitions

Method transfer studies provide documented evidence that analytical procedures can be successfully implemented across laboratories while maintaining performance, consistency, and compliance.

Consistent Analytical Performance

Transfer studies help ensure that analytical procedures generate equivalent results regardless of laboratory location, equipment platform, or testing personnel.

Reduced Operational Risk

A structured transfer process minimizes the likelihood of transfer failures, analytical discrepancies, investigation burden, and delays in routine testing activities.

Faster Laboratory Readiness

Documented transfer protocols and verification activities accelerate laboratory onboarding and support efficient implementation of analytical procedures.

Regulatory Compliance

Method transfer studies support compliance with USP 〈1224〉 Analytical Procedure Transfer guidance, FDA expectations, and global pharmaceutical quality requirements. Documentation generated during transfer activities helps support inspections, audits, technology transfer programs, and regulatory submissions.

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