1. Mailing and Physical Address and Phone Numbers:

• West Coast Analytical Service, Inc. (only location)
• 9240 Santa Fe Springs Rd.
• Santa Fe Springs, CA 90670
• 562-948-2225
• Fax 562-948-5850
• Web site http://www.wcas.com

2. Person responsible for questionnaire completion:

• Dr. D.J. Northington, Technical Director
• 562-948-2225 x 103

3. Products and services:

We primarily offer analytical chemistry services, i.e. chemical testing services, for the pharmaceutical, nutraceutical, and environmental industries.

4. Date established: 1984

5. Number of employees: approximately 40

6. Quality Assurance (QA) and Quality Control (QC):

Our company operates routinely under FDA GMP as a quality control laboratory. QA is an independent monitoring function of the operations, reporting directly to the President. QC is the function performed during the tests to monitor precision, accuracy, and other analytical testing criteria. QC is performed by the analysts as they are performing the tests.

WCAS has a QA Manual and a formal QA Program in compliance with California Environmental Laboratory Accreditation Program (ELAP) and FDA GMP regulations. The QA Manual is reviewed annually. We are also capable of FDA and EPA GLP compliance when the study is properly setup before hand.

7. ISO Certification: 

No, but most lab accrediting authorities who audit WCAS comply with ISO Guide 25.

8. FDA Registration Number: 2030726/LOS

9. CA ELAP Certificate: 

Certificate #1268, accredited since the beginning of the ELAP program in the mid 1980’s.

10. Is WCAS subject to inspection or audit:

Yes. FDA has audited our lab twice. Our last inspection report is available at FDA 483. In one case the audit was triggered by a drug application, but FDA did a general systems audit.

CA ELAP also inspects our lab every 2 years.

EPA has audited our lab once in response to a pesticide application in which data from a GLP project was submitted in support of the application.

Clients routinely visit our labs for audits. We average about 2-3 audits per month.

11. QA Policies

A) Raw Materials Control, Supplier Qualification.

While we do not test incoming raw materials against their specifications, we do compare them against a second source. For example, if a copper standard is used, the test will include a comparison to a reference sample, usually an NIST SRM or other well documented reference sample. In the case of reagents used in titrations, these are standardized frequently, usually with every use, against primary standards. In the case of general reagents, which may effect % recovery or blank contamination, these are monitored with every batch of test samples.

In most cases we do not audit subcontractor laboratories or vendors. We believe that this would be a confidentiality problem or a conflict of interest problem, since most subcontractors would also be competitors. We have audited Watson Brothers who certify our weights and balances annually.

B) Instrument Calibration.

There are three pieces of laboratory equipment that fall under the category of metrology performed by QA. These include thermometers, mechanical pipettes, and balances. In each case, the calibration is checked periodically with weights and measures traceable to NIST, all covered in SOPs. Other instruments are calibrated at the time of use for particular tests according to methods or SOPs.

C) Training.

Training records are kept according to GMP regulations. Training is usually conducted "on-the-job", teaming a qualified analyst with one in training. Training is also conducted in QA Meetings every other month, at which time regulations, new or updated SOPs, and other QA issues are covered. Training is also conducted on specific instrument or analytical specialties like HPLC or ICPMS during both in-house and external seminars. Training records are explained in SOP 140.

D) Document Control.

The manner in which SOPs and copies of SOPs are reviewed, revised, distributed, and tracked is explained in SOP 101.

E) Customer Complaints.

See SOP 190. Any complaint which expresses serious concern over the quality of our data, or significantly questions a result is logged on a complaint form and an investigation conducted. We attempt to resolve the conflict with the client.

F) Retest / OOS Policy.

See SOP 2230. The OOS investigation is only conducted if the client has supplied the material specification with the analytical request.

Out of control QC parameters do not cause an OOS investigation. These are handled separately through QC procedures including data package signature forms and corrective action forms.

G) Traceability.

All test measurements are traceable to NIST through the use of traceable weights and measures, as well as the use of reference samples from NIST, USP, USEPA, USGS, etc..

H) Client notification of QC problems.

Reports include precision and accuracy data. Any out of control data which may affect data quality is identified in the report.

I) Planned and unplanned deviations from methods and SOPs.

For GLP purposes, planned deviations require preparation of amended SOPs and Study Director approval. No such requirement exists for GMP.

Unplanned deviations are common because either the sample matrix is not covered by the method, there are unexpected interferences, or the method is poorly written. In any case, unplanned deviations (and planned deviations for GMP) in methods or SOPs are documented in the sample preparation bench sheet, the analysis bench sheet, and the data package signature page.

Note that because of problems with sample matrixes, methods, and new scientific information, WCAS reserves the right to modify methods in our standard Terms and Conditions. Modifications are not made lightly and are documented. Significant modifications in sensitive regulatory areas are made with prior approval of the client.

J) Record retention.

Raw data is stored for 5 years. We realize that this is not long enough for many of our clients, however it would be difficult to track the data retention requirements for every product and client. Therefore we recommend that clients order a GMP data package to store themselves. This data package includes copies of all hard copied raw data, complete explanations of sample preparation and analysis, and an independent QA review of all QC parameters. Such a report is generally priced at 25% of the analytical costs, or a minimum of $250 per test method.

K) Instrument Qualification.

See SOP 2250.  Equipment goes through Installation Qualification (IQ) during installation. This generally includes documentation that the equipment meets all manufacturer and WCAS specifications and any installation requirements.

Annually the equipment is Operationally Qualified (OQ). The point of OQ is to demonstrate that methods are transferable, that any calibrated flows or temperatures are accurate, and that comparable results are achievable on similar systems.

Performance Qualification (PQ) is performed during the analysis of samples. This includes documenting systems suitability criteria, calibration, and other quality control parameters.

L) Method Validation.

Not all methods and SOPs have been validated. Methods from compendial sources such as USP, ACS, and EPA do not require validation. Instead they generally require system suitability or an initial demonstration of performance.

Methods which are developed by WCAS may be validated. However, each method should be fully validated on the clients product or material. See SOP 2220 for minimal validation requirements. Contact us for a price quote and validation protocol.

M) Expiration dates.

Both GMP and GLP require adherence to expiration dates. Expiration dates are documented on reagents and standards. Standards where stability is questionable have been put through a stability study.  See SOP 2100.

N) Sample storage and disposal.

Samples are stored according to label requirements or EPA protocols. Refrigerators, freezers, and room temperature storage areas are monitored with min/max thermometers, and the readings are checked each work day. Samples are kept in storage for 30 days after the report is mailed. The report will include a post card for the client to return with sample disposal or return instructions. Samples are not generally stored for extended periods of time.

O) Approval of test data.

Senior analysts review and approve all data before it can be released. Any QC outliers must be documented and approved by a Project Manager or the QA Officer prior to release. Any results which are outside of material specifications undergo an OOS investigation. Any problems which affect data quality are identified in the report. The final report is reviewed and signed by two senior analysts, usually including the QA Officer.