Pharmco Product, Inc. SOP # : 8-2-4-A Rev 2.

1 10/16/06 EF

Subject: In Process & Final Inspection & Testing

-1-
SOP 8-2-4-A

Created by QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002

1.) Scope:
Policy and procedure for testing of in-process and Finished Product samples as
well as final inspection of finished goods.

2.) Normative References:

SOP 4-2-2 Quality Manual
SOP 6-2-2-A Hazardous Communication Program
SOP 6-2-2-C Chemical Hygiene Plan
SOP 7-5-1-A Product Files
SOP 7-5-1-C General Manufacturing Procedure
SOP 7-5-1-E & 8-2-4-A Sample Collection
SOP 7-5-2-A Validation of Product and Processes
SOP 7-5-3-A Lot, Batch & Serial Numbering System
SOP 7-5-3-B Retain Sample Program
SOP 7-5-3-C & 4-2-3-I Certificates of Analysis
SOP 8-1-0-A General Laboratory Procedure
SOP 7-5-1-G cGMP Procedures
WI Test and Re-test Procedures
WI Handling OOS Results
Form QA304 Non-Conforming Product

3.) Terms and Definitions:

In Process Sample: Sample taken during the compounding process. The
process may not be completed. The in-process sample is used as a measure
against conformity to product specifications.

Finished Product Sample: Sample of the completed product after the material
has reached the final container.

COA: Certificate of analysis. The actual chemical analysis for that particular lot
of chemicals.

COA Template: The original or master document for COAs for each chemical.
The template lists each specification required in the chemical product
monograph, i.e. the product Grade designation. The template also lists the
product limits (maximum and minimum requirements) for each specification. The
Pharmco Product, Inc. SOP # : 8-2-4-A Rev 2.1 10/16/06 EF

Subject: In Process & Final Inspection & Testing

-2-
SOP 8-2-4-A

Created by QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002

template lists a set of data for these specification (results) from some previous
testing review. The COA Template in most cases should (but does not
necessarily have to) match the specifications on the product label.

Product File: Product documentation verifying origin of manufacturing site,

receipt, source, quality review and ultimate disposition for each lot of chemicals
moving through our facility. Product files are used for all chemicals. The
information in each product file is as listed on FormQA100. Product files are also
the vehicles by which the correct labels are produced for finished product
manufactured from in-bound raw material. Product files are also the vehicles by
which labels are generated for all third party vendors manufacturing product and
private labeling for Pharmco.

Batch Record: Document that details the materials and production processes
for a particular production run.

Pure Ethanol: Any ethanol product that consists of pure ethanol or a mixture of
pure ethanol and water.

Denatured Ethanol: Ethanol that is rendered unfit for drinking purposes as

designated by the Bureau of Alcohol Tobacco and Firearms (BATF)

Specially Denatured Alcohol: Specially denatured alcohol (SDA) is a type of

denatured alcohol. SDA is often used in industry. If a customer wants to
purchase more than 5 gallons of SDA in one year, that customer must obtain a
permit from the BATF.

Completely Denatured Alcohol: Completely denatured alcohol (CDA) is a type

of denatured alcohol. Due to its odor and other properties, the use of CDA is
limited. A customer does not need a permit to purchase this type of alcohol.

Cut Alcohol: Pure Ethanol that has been blended with water to reduce the proof
of the finished product.

Ethanol Solvents: Ethanol based formulas approved by the Bureau of Alcohol,

Tobacco and Firearms for use as a solvent.
Pharmco Product, Inc. SOP # : 8-2-4-A Rev 2.1 10/16/06 EF

Subject: In Process & Final Inspection & Testing

-3-
SOP 8-2-4-A

Created by QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002

Reagent Solvents: Non Ethanol Based Solvents which are single component
chemical liquids, i.e. Acetone, IPA, Methanol.
4.) Flow Charts:
QUALITY PLANNING, REAGENTS AND SPECIALTY CHEMICALS, AND NEW PRODUCTS

Established
Products: ISO
Reagents and New Product
Committees
Specialty
Chem icals

Non-routine VP Reagents
order, special or Yes & Specialty
new Chemicals
requirements ?

No

Quality Plan
ISO SOP's

Quality
Assurance
and Document
Control

Quality Control
Laboratory

Labels
Product File
Generated

Label Request
Production

Packaging Yes
?

No

Customer
Pharmco Product, Inc. SOP # : 8-2-4-A Rev 2.1 10/16/06 EF

Subject: In Process & Final Inspection & Testing

-4-
SOP 8-2-4-A

Created by QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002

QUALITY PLANS

Marketing Idea
example: we want to Customer Request
manufacture electronic requiring extra resources
grade chemicals not currently available

Quality Plan
Request

VP R&S

Fills out form

and circulates

No No further
Approved?
action

Yes

QA & DC ISO SubCommittee

Notes added to File Decides how resources

Product File will be obtained to meet
the product requirement

QA & DC

Verifies all
actions are
completed

Normal
Processes
Pharmco Product, Inc. SOP # : 8-2-4-A Rev 2.1 10/16/06 EF

Subject: In Process & Final Inspection & Testing

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SOP 8-2-4-A

Created by QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002

BULK PRODUCTS INSPECTION AND TESTING

Other Bulk
Chemicals
Bulk Ethanol
[In Tanks and/or
Filling Lines]

Quality Quality
Control Control

Product File Product File

Approval Approval Approval

Production Production

Sample Sample Sample

Batch Record
Batch Record

Pure Ethanol
SDA Products Product

Customers Customers
Pharmco Product, Inc. SOP # : 8-2-4-A Rev 2.1 10/16/06 EF

Subject: In Process & Final Inspection & Testing

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SOP 8-2-4-A

Created by QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002

REAGENT AND SPECIALTY, AND NON-BULK CHEMICALS INSPECTION AND TESTING

VP Reagents
& Specialty
Chemicals

Pharmco PO Supplier
for Raw
Materials

Drums Arrive

Quality Control, Quality

Assurance & Document Validation/QC
Control Quarantine

Label Room

Released from
Product File Release Label Quarantine

Process / Packaging at
Package No
3rd Party
On-Site? Location

Yes

Batch Record

Production
Batch Record
Labels

Product to
Customer
Pharmco Product, Inc. SOP # : 8-2-4-A Rev 2.1 10/16/06 EF

Subject: In Process & Final Inspection & Testing

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SOP 8-2-4-A

Created by QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002

New Products

Marketing Customer
Information Request

VP R&S

Decides to
manufacture
new product

VP F&A
Creates a catalog New File
entry, with all created in
product Open
specifications, Systems,
label, including
catalog #, cost, additional
selling price information
(DOT, etc)

New product
Generates a entered into
PO computer
system

Product file
generated
(SOP 2.5)

Standard
Procedures
Pharmco Product, Inc. SOP # : 8-2-4-A Rev 2.1 10/16/06 EF

Subject: In Process & Final Inspection & Testing

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SOP 8-2-4-A

Created by QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002

5.0) Text:
Monitoring and Measurement of Product
In accordance with the 9001:2000 standard, Pharmco must monitor and measure
the characteristics of the product to verify that product requirements have been
met. This is required during appropriate sages of the product realization process.
Evidence of conformity with acceptance criteria indicating the person authorized
to release the product is maintained in the quality control dept. in accordance
with 4.2.4 of this standard.
Product release and service delivery cannot proceed at Pharmco until all other
requirements have been satisfied.

Sampling and Testing of In-process Materials

Quality Control has the responsibility and authority to ensure:
* Written procedures are established to assure batch uniformity and integrity of
all products. These shall include:

1.) In process controls

2.) Tests to be conducted on samples of in-process materials of each
batch.
3.) Parameters required for mixing and compounding properly
4.) Specifications for that particular product.

Pharmco complies with all the above parameters. In process samples are sent
to our QC laboratory for analysis. Samples are marked RM (Raw Material), IP
(In Process) or FP (Finished Product) by the operator in order designate the type
of sample. The batch record for that product also accompanies the sample or is
already in the possession of QC.

Testing of all in-process samples is documented. The data is attached to the

Certificate of Analysis and included in the Product File for that Lot.

If the sample does not conform, the lab immediately notifies production.
Production will continue to mix the product or re-work the material.
Pharmco Product, Inc. SOP # : 8-2-4-A Rev 2.1 10/16/06 EF

Subject: In Process & Final Inspection & Testing

-9-
SOP 8-2-4-A

Created by QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002

In the event that the material has been altered beyond conformity, a non-
conformity report will be issued. The procedure specified in SOP 8-3-0-A
Control of Non-Conforming Product will be followed. Refer to SOP 7-5-1-C
General Manufacturing Procedures, SOP 8-2-4-A In Process & Final
Inspection and Testing, and 7-5-1-G cGMP Procedures for additional
information.

Product Inspection (Finished Product/ Post-pack Inspection)

It is the Responsibility and Authority of Production and Quality Management to
ensure that:
* Final inspection is performed on packaged items for, label, lot and package
correctness.

* Final Inspection and testing is done

Finished Product Samples will be sent to the lab for analysis. The above
procedures will be followed.

First saleable container form the batch will be sampled and send to the
laboratory for analysis.

In many cases of pure solvent, the in-process sample is taken to the lab in
the final package and will thereby be considered the in-process and Final
Sample.

When product is packaged from drums that have already been released:
In this case, a small retention sample is taken for Identification (IR) and
retention.

Completion of the final inspection constitutes the shipping release. The person
responsible for shipping will:
1. Confirm that the laboratory evaluation is completed and approved
2. Confirm that the product, amount and labels agree with the bill of lading

Once the shipping release is completed, the production operator will sign the bill
of lading. The order can then be shipped.
Pharmco Product, Inc. SOP # : 8-2-4-A Rev 2.1 10/16/06 EF

Subject: In Process & Final Inspection & Testing

- 10 -
SOP 8-2-4-A

Created by QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002

Refer to SOP 7-5-1-C General Manufacturing Procedures, and 7-5-1-G

cGMP Procedures for additional information.

For Rules on re-testing Rejected Samples refer to WI Test and Retest

Procedures and Handling OOS Results

General Parameters
All bulk solvents brought in to Pharmco are sampled and tested according to
Testing and evaluation of incoming raw materials). Once the material has been
approved certain grades of material can be packed without re-evaluation.
Specifically, if solvents are packaged for Reagent ACS grade, re-testing is not
warranted. It can be done if requested for other reasons (if the water
specification is critical for instance). If a UV component of a finished product is
required (as is the case for all General Use HPLC grade solvents manufactured
at the Brookfield facility), then re-testing for those parameters must be performed
prior to release. If the product is certified as USP then testing of in-process and
final package samples will be performed. Re-testing of material is therefore
product specific and performed according to the specifications listed on the COA
Template. VP QM will review those requirements on a case-by-case basis in
accordance with the quality review being conducted for all products.

Products are re-tested for all line changes. Therefore, if the product remains in a
dedicated system and has already been tested through the line and in the
package, not further testing will be warranted unless specifically requested.

Pure Ethanol will follow a similar logic depending upon the end use of the product
and will be determined by the VP Operations. All bulk Ethanol is evaluated for
USP and ACS specifications if it is put into our storage tanks. If a tank truck of
material is brought into the facility and not off-loaded and is used to create an
SDA, then clearly full USP testing for Pure Ethanol is not warranted as this is not
the intended grade of resale. Similarly if ethanol is used from the storage tank
and filled on the automated filling line, retesting will only be necessary to ensure
that product contamination has not occurred. Full testing is not warranted but
only those parameters (GC, UV, Spec. Gravity and Water) deemed critical to
product performance.
Pharmco Product, Inc. SOP # : 8-2-4-A Rev 2.1 10/16/06 EF

Subject: In Process & Final Inspection & Testing

- 11 -
SOP 8-2-4-A

Created by QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002

Expiration Dates and Re-testing of Inventory

Expiration dates for alcohol are a function of the customer end use and
packaging. This will be evaluated and issued on a case-by-case basis.
In general, Pure 190 and 200 proof, pure, ethanol is rated with a shelf life of 36
months from the date of manufacture.

Most but not all SDAs have a rating of up to 5 years.

The UV component of Pure Ethanol is extremely sensitive and can fail within 3
months depending on the package. Therefore, shelf life is a function of customer
application.

Product integrity is highly susceptible to storage condition. All products should

be tightly sealed and stored in a consistently cool, dry area. It is the end users
responsibility to monitor the storage conditions and their effects on the products.

Variances to this expiration date policy are documented on a case-by-case basis.

Note that these expiration dates are based on industry experience with
Pharmcos products and packaging materials.

See SOP 7-5-3-C for information on expiration dates on COAs.

Pharmco has a rapid turn over of products in inventory. However, if products are
stored in inventory for longer than these recommended periods, the products
must be re-tested before they are shipped.

Records
Records of the final inspection and testing procedure will be maintained for a
minimal period of 3 years. These records will be stored in the Quality Control
Department until they are archived.

QC Data Sheets
Final inspection and testing data generated in the Quality Control Laboratory will
be recorded on the appropriate QC Data Sheets. When no appropriate QC data
sheet is available, the data generated will be recorded and included with the
Batch record or product file.
Pharmco Product, Inc. SOP # : 8-2-4-A Rev 2.1 10/16/06 EF

Subject: In Process & Final Inspection & Testing

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SOP 8-2-4-A

Created by QC/ Edited by Paul DiMarco Approval/Effective Date: 01/01/2002

Certificates of Analysis
A Certificate of Analysis will be generated for each sample that meets the
product specifications.

Shipping Release
The shipping release consists of: verification that all quality tests are complete;
and verification that the shipment matches the bill of lading. The shipping
release must be done before an order can be shipped. This is explained in
greater detail in SOP 7-5-1-C General Manufacturing Procedure.

Revision History
Revision Revision Date Revised Reason for Revision
# by
Revision History EF
started on
10/16/06
2.1 10/16/06 EF Start revision history, check for accuracy, add
reference to work instructions. Retraining is
not required on this revision.

This printed document was printed on: 3/12/2007.

This printed document is valid for 5 days after the print date. All obsolete documents must
be appropriately marked or discarded.