1. Mailing and Physical Address and Phone Numbers:

• Exova Inc. (formerly West Coast Analytical Service, Inc.)
• 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:

• Lorraine Shelton, QA Officer
• 562-948-2225 x 107

3. Products and services:

We primarily offer analytical chemistry services (chemical testing services) for the pharmaceutical, dietary supplement, medical device, consumer product, and environmental industries.

4. Date established: 1984

5. Number of employees: approximately 40

6. Size of facility: 35,000 sq. ft.

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

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

We have a QA Manual and a formal QA Program certified as compliant with the California Environmental Laboratory Accreditation Program (NELAP recognized) and inspected for compliance with FDA cGMP regulations. The QA Manual is reviewed annually. We are also capable of FDA and EPA GLP compliance with pre-approval of the study protocol and QA witnessing of critical control points.

8. ISO Certification: 

We are not currently ISO certified, but our systems have been designed to comply with ISO 9001 and 17025.

9. FDA Registration:

Facility Establishment Identifier/Data Universal Numbering System Number: 3000203007/126601801

10. CA ELAP Certificate: 

Certificate #2652, accredited since the beginning of the ELAP program in the mid 1980’s.

11. Is the laboratory subject to inspection or audit:

Yes. FDA has audited our lab six times.

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.

12. QA Policies

A) Raw Materials Control, Supplier Qualification.

While we do not test incoming raw materials against their specifications, certificates of analysis are reviewed by QA as part of our incoming materials system. We also qualify working standards 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 (or other primary standard) traceable Certified Reference Material (CRM). In the case of reagents used in titrations, these are standardized frequently against standards traceable to a primary standard. In the case of general reagents, which may affect analyte recovery or blank contamination, these are monitored with every batch of test samples.

We do not audit our vendors. We do not subcontract analytical work, unless pre-approved by the client. It is the client's responsibility to then qualify the subcontract lab. We use ISO 17025 certified calibration service providers.

B) Analytical Instrument Qualification.

All analytical instrumentation is Operationally Qualified at least once per year. There are three categories of laboratory equipment that fall under the responsibility of in-house metrology: thermometers, mechanical pipettes, and balances. Calibration is verified periodically with weights and measures traceable to NIST, as formalized in our SOPs. Instrumentation is qualified before use and following major repairs (Installation Qualification and Operational Qualification). Complex analytical instrumentation is qualified holistically and/or calibrated at the time of use for particular tests according to system suitability criteria published in standard methods or SOPs (Performance Qualification).

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 during both in-house and external seminars. Efficacy of Training is established on an annual basis for elements of an analyst's curriculum, based on a review of the analyst's data, including performance during third-party proficiency testing. Training documentation is explained in SOP 140.

D) Document Control.

The manner in which controlled documents, including test methods, are reviewed, revised, distributed, and tracked is explained in SOP 101. Laboratory data is recorded on controlled worksheets or bound laboratory notebooks, issued by QA.

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 into a complaint database and an investigation conducted. We attempt to resolve the conflict with the client. Complaints are trended by QA and reported to management.

F) OOS and Laboratory Investigation Policy.

See SOP 2230. The OOS investigation is only conducted if the client has supplied a material specification with the analytical request or indicates that a sample result is out-of-trend or aberrant.

Out of control QC or system suitability parameters do not require an OOS investigation. These are handled separately through data review procedures and corrective action forms.

G) Traceability.

Test measurements are traceable to primary standards through the use of NIST traceable weights and measures, traceable secondary standards, and the use of primary standards from NIST, USP, USEPA, USGS, etc..

H) Non-Conformances (Deviations) and Corrective/Preventative Actions (CAPA)

Reports include QC data, including demonstration of precision and accuracy. Non-conformances (deviations) which may affect data quality are identified in the report, including an impact assessment. Planned deviations require client pre-approval. Unplanned deviations most commonly result from use of test methods that have not been validated in the client's particular sample matrix, resulting in unexpected interferences. Deviations from methods or SOPs are documented in the raw data package and corrected or justified. Each raw data package is reviewed by a second analyst or supervisor. In addition, GMP work is audited by QA. Laboratory errors are documented, corrective and preventative actions identified, and a root cause analysis performed. CAPAs are tracked to completion and trend analyses are performed by QA. Management is updated regularly on evolving trends and timeliness of NCR/CAPA closure.

I) Record retention.

Raw data is stored for five (5) years. We realize that this is not sufficient for many of our clients, however it would be difficult to track the data retention requirements for every product, industry, and client. Therefore we recommend that clients order a GMP data package in order to archive the raw data associated with testing themselves. This data package includes copies of all hard copy raw data, complete explanations of sample preparation and analysis, and documents an independent QA audit of the raw data. Complete data packages will be provided at an additional cost.

J) Method Validation.

Not all methods and SOPs have been validated in each potential matrix. Methods from compendial sources such as USP, ACS, and EPA may not require full validation. Instead they generally require demonstration of system suitability or another form of initial demonstration of performance (method qualification). Methods which are developed by our laboratory or a client may be validated on the client's product or material in accordance with USP <1225> and ICH 2Q (R1) or qualified per USP <1226> upon request. See SOP 2220 for minimum validation requirements. FDA requires non-compendial methods for in scope GMP work to be validated or transferred for each matrix. Contact us for a price quote and for assistance in developing a protocol.

K) 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.

L) 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, have audible alarms, 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.

M) Internal Audits.

QA performs data and system audits according to SOP 250.