Selleck Quality Manual
1. Selleck Quality Policy

5. Quality Manual

Selleck Chemicals is committed to being the leading global supplier for research,development, and manufacturing in life science and innovative technology. To achieve ourstrategic vision, we must meet and exceed customer requirements. We will realize this goalby establishing and maintaining outstanding Quality and Quality Assurance standards.

This document details the corporate quality policy, structure of the Company, and references
appropriate to Operating Procedures.

2. Product Dating Information Statement
Selleck Chemicals has programs to monitor, preserve, and protect the quality of ourproducts. For materials where shelf life information is a specific requirement, we havedefined expiration and retest periods in our specifications product level information
database which are used to generate corresponding expiration dates and recommend
re-test dates (batch level information). The Quality Release Date on the Certificate ofAnalysis is the original date the batch data was reviewed against specification. If a productwas retested as part of a recurring inspection or Recommended Retest, the actual Date
Retested will be additionally displayed on the Certificate of Analysis. This program reflects
Selleck Chemical’s commitment to providing materials that meet customer requirements.
When dating is indicated by month and year only, the product is expected to meet
specifications until the last day of the month.

3. Shipping Conditions & Recommended Long-Term
Storage
According to your experimental design, select a suitable solvent to prepare a concentrated
stock solution. The information of solubility can be found on the product page of our ebsite,which is tested by our Quality Control Department. For in vitro experiments, DMSO is oftenused to make stock solution. Afterwards, it is diluted to make the working solution (e.g.
1:1000 dilution in cell culture medium). A typical table for solubility is explained below:
INSERT TABLE HERE
1 Shipping Conditions
When there is short-term exposure (i.e. during shipment) to conditions other than thoserecommended for long-term storage that will not affect product quality, Selleck will ship at
ambient temperature. If you receive the product at room temperature, please rest assured,
the Selleck Quality Inspection Department has conducted experiments to verify that thenormal temperature placement of one month will not affect the biological activity of powder
products. After collecting, please store the product according to the requirements
described in the datasheet.

(1) Document Control
Quality Management System policies and procedures are maintained under document
control. Procedures include administration, manufacturing, analytical methods, equipment
operation and others.
(2) Training
The policy of Selleck Chemicals is to ensure that all personnel are trained andexperienced to the extent necessary to undertake their assigned activities andresponsibilities effectively. The company generally procures and recruits employees
capable of meeting the technical, skill, experience, and educational requirements ofSelleck Chemicals' activities.
All staff and senior employees are responsible for recommending the training needs ofothers, and for ensuring that all employees allocated specific tasks are suitably qualified
and experienced to execute those tasks. Once training needs are identified, it is then theresponsibility of the Directors to provide the training necessary. Full records aremaintained of all training undertaken by employees.
(3) Customer Complaints
Customer complaints are communicated to the appropriate site for review andinvestigation. These locations have procedures that define how the complaint isinvestigated and, when applicable, corrected for. The procedures define the actions
necessary to accomplish field corrections or to implement a recall on particular products.
In the event of a recall, affected customers will be identified and contacted.

6. Supply Chain
Our suppliers’ materials & services can be qualified using a combination of criteria such as
assessment questionnaires, on-site audits, historical performance (quality, on-time delivery),
and/or third party accreditation. New and alternative suppliers are qualified when necessary
to maintain product supply, purity, and competitiveness.

7. QA/QC Staffing
The Selleck Quality Assurance / Quality Control program staffs over 35 employees.

2 Recommended Long-Term Storage
The storage conditions that Selleck’s publications and labels recommend for products aredeliberatively conservative. For many products, long-term storage at low temperatures will
increase the time they are expected to remain in specification, and are therefore labeledaccordingly.

Organic Chemistry Lab 1
Organic Chemistry Lab 2

Manufacturing Facility

Organic Chemistry Lab 3
Organic Chemistry Lab 6
Biochemistry/Molecular Biology Lab

The recommended long-term storage temperature for different types of products isdifferent, please store according to the instructions of each product.

VP

Quality Control Department

Analytical Chemistry Lab

NMR LABHPLC LAB
Mass LAB

Bio Test Lab

Puchasing/Sourcing Department
Warehousing System

Warebouse 1
Warebouse 2
Warehouse 3

4. Quality System

General Manager

Sales Department
VP

Customer Service Department
Tech Support Department

The Quality System applies to all activities of the Company, and is fully documented andstructured in the chart 1.

Marketing Department
ManagerChemistry Tech Support
Biochemistry Tech Support
Logistics Department
Pricing System
Public Relations

IT Department
ManagerChart 1

Phone: 03-5615-9297
FAX: 03-5615-9298

www.selleck.co.jp

Account
Human Resource

Departmental Organizational Structure

info@selleck.co.jp

8. Process Control

9. Product/Batch Documentation

The Selleck Quality Assurance / Quality Control program staffs over 35 employees.

(1) Product Specifications & Certificate of Analysis (C of A)
The majority of Selleck products have established product specifications. A product'sspecification information may be found on the Certificate of Analysis, catalog listing, and/oron the label. Certificates of Analysis report batch level information including:(1) Procedures
Documentation exists for providing appropriate instructions for producing and testing final
products. If changes to the manufacturing or testing process are warranted, the work
instruction document(s) will reflect the procedural change.
(2) Equipment
Critical equipment, defined as equipment where monitoring and output are controlled andrecorded, is maintained in a calibration and testing program. Where applicable, traceablestandards are utilized. Documented procedures exist for equipment operation, calibration,and maintenance, and can also include how the equipment is cleaned. Equipment andusage records are maintained and available. Equipment tags are also employed to further
indicate equipment calibration and maintenance status.
(3) Quality Records
Where appropriate, quality records for a product’s lifecycle within Selleck Chemicals aremaintained and available. Quality records may include: customer inquiries, including orders
and complaints, raw material information, in-process manufacturing and testing data,
packaging, final quality analysis, batch disposition, training, and equipment. A product andbatch numbering system is employed to allow for traceability throughout the entire process.
(4) Nonconformance
When a batch is determined to be nonconforming to product specifications, the batch is"flagged" in our electronic systems and may also be physically labeled and/or segregatedto reflect this "blocked" status to prevent shipment. Procedures exist to describe thisprocess.

Phone: 03-5615-9297
FAX: 03-5615-9298

Formula and formula weight
CAS numberStability
Molecular structure
Analytical test results
Certificates of Analysis are available upon request from our Technical Services Group atwww.selleck.co.jp.
(2) Analytical Test Methods
Some of the analytical methods used by the Quality Control groups to test Selleck products
are available. Specific analytical methods can be requested from our Technical Servicegroup.
(3) Product Information Sheets
Certain products include a product information sheet, which provides general productinformation or specific product usage instructions. Product Information Sheets can befound at www.selleck.co.jp, requested from our Technical Service group, and included inthe shipment.
(4) Container Label
Product information provided on the container label include:
Product and batch number
Product name
Physical chemical properties
Material is available for retest for batches that are in stock. Sample quantity availability willvary depending upon the product. Certain products may have retained material frombatches no longer available. Inquire for availability on specific products.

www.selleck.co.jp

info@selleck.co.jp