E-708

Creating New Packaging Component Specifications

Section E — Materials Management Revision 0 7 pages

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1.0 Purpose

The purpose of this SOP is to describe the procedure used in maintaining and reviewing new
incoming packaging component specifications documentation to ensure both required quality
standards and regulatory requirements are met for safe food contact (Dietary Supplement),

Cosmetic and OTC products.

2.0 Scope

This procedure applies to all packaging components /materials used to contain food related
product/material or any other finished product material manufactured by Ion Labs, Inc.

3.0 Responsibility

3.1 It is the responsibility of Purchasing, Process Engineers, Quality Control and Quality
Assurance, or designee to manage and ensure overall compliance with this procedure.

SZ It is the responsibility of Purchasing to send as well as notify the Process Engineer of
any updates on vendor provided documentation associated with packaging components
including: technical drawing specifications, regulatory information indicating the
container is safe for food /product contact (Certificate of Compliance), and the PO
containing the Packaging Component ID number based on the type of component.

33 It is the responsibility of the Process Engineer or designee to create an internal
packaging component specification sheet based off of the documentation provided for
each component, and to ensure that this documentation is approved and signed by
Quality. The Process Engineer will notify Quality Control Management when
documentation is completed and approved. The Process Engineer will maintain all
records of all packaging component specifications including the Packaging Component
index.

3.4 It is the responsibility of the Quality Systems Manager or designee to ensure

documentation submitted containing the data and specifications for each packaging
component is approved by Quality and submitted electronically to Document Control.
These approved documents will be made available to the Quality Control Supervisor and
Incoming Inspection Department.

Sa It is the responsibility of Quality Assurance to ensure the completed packaging
component specification meets all internal and regulatory requirements prior to approval.

3.6 It is the responsibility of Production, Quality Systems, Quality Assurance and Document

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Creating Ne S w tt aa P nn a dd c a k r a d g O i p n e g r a C t o iin m ng g p o P n P r e o n ce t d u S r p e e cifications SFOaP sNo Re0 v | Pa2g oef 7

Control management to ensure this procedure is implemented and followed.

4.0 Definitions

4.] Packaging Component — any type of packaging component (bottles, caps, scoops,
desiccants, etc.) used as a final packaging container that comes into contact with finished
product.

4.2 PO - Purchase Order provided by Purchasing.

4.3 Packaging Component ID — an internal number assigned by Accounting to identify a
type of packaging component.

4.4 Packaging Component Specification Form — an internal specification form listing
component description, component dimensions, the packaging component ID, and
manufacturer.

4.5 Certificate of Compliance - (C of C) - regulatory documentation used to ensure
component coming into contact with finished product is safe for food use.

4.6 Packaging Component Index — a reference document listing the Packaging Component
ID and its description based on specification.

4.7 AVL — Approved Vendor List

5.0 References

5.1 E-101, SOP, Warehouse and Inventory Control

5.2 E-601, SOP, Vendor Qualification

5.3 C-502, SOP, Record Storage, Retention, and Destruction

6.0 Procedure

6.1 Purchasing will notify the Process Engineer or designee upon receiving a new packaging
component. The Process Engineer will initiate the creation of a new packaging
component specification sheet according to documentation provided consisting of: PO
containing Packaging Component ID and product description, technical specifications
and drawings for materials associated with the component, and CofC compliance
documentation acknowledging if the component is safe for food use/intended use (i.e.

meets FDA Food, Drug and Cosmetic Act Federal Regulations).
6.1.1 The Process Engineer will verify with Purchasing if the packaging component

supplier is an approved vendor on the Approved Vendor List prior to proceeding
with creating the specification.

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Standard Operating Procedure SOP No | Rev Pave tor?
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6.1.1.1 Ifthe vendor providing the component is not on the list, Purchasing will
initiate a Vendor Evaluation Form (E-601-F2) and forward on to the
Quality Specialist begin the vendor qualification process.

6.1.1.2 Upon completion of the vendor qualification, the Quality Specialist will
notify the Process Engineer and Purchasing of adding the new vendor to
the Approved Vendor List.

6.2 Creation of the Packaging Component Specification Sheet

6.2.1 Create a new folder in Technical Drawing and Specifications located on the F:
drive, naming the folder by Packaging Component ID assigned via PO and save
all technical documents provided by Purchasing electronically into this folder for
reference. (F'/Doc Control Only/Technical Drawings and Specifications).

6.2.1.1 Print a hardcopy of all technical documentation received by Purchasing.
Examine the required documentation is present including all regulatory
(CofC) information. If not provided, request Purchasing to contact
vendor to provide a copy.

6.2.1.2 Write the Packaging Component ID on all hardcopies of the
documentation associated with the corresponding Packaging
Component ID. (Example: Bottle — PB0050; Cap — PC0100; Scoop —
PK0200). Highlight documentation indicating the component is safe
for food / intended use for quick reference.

6.2.2 Open the corresponding template form (See Attachment 8.1) based on the type of
packaging component to be completed and save into the newly assigned
Packaging Component ID folder (Example: PC0244 Packaging Component
Specification Form).

6.2.2.1 Enter all pertinent specification information for the component into the
Packaging Component Specification Form using the technical and

regulatory documentation provided.

Note: Review all fields for accuracy noting all dimensions (significant
figures), units of measure (convert mm to inches if applicable),
as well as all other fields agree with what is listed on the
technical documentation. Should the documents not be in
English or translatable, contact Purchasing for additional
information.

6.2.2.2 The Process Engineer or designate will sign off on the Packaging
Component Specification Form and attach all technical/regulatory
documentation to present to Quality for final review.

6.3 Completing the Packaging Component Specification Review Process

6.3.1 Upon completion of the documentation, the Quality Specialist or designee will

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Standard Operating Procedure SOPNo | Rev
Creating New Packaging Component Specifications E-708 0 Page 4 of 7

verify if the packaging component was purchased from a qualified vendor as
listed on the AVL, examine the documentation for accuracy and completeness of
the Packaging Component Specification form, and assure that all other required
regulatory information is provided to ensure the component is safe for food
use/intended use.

6.3.2 Upon approval, the Quality Specialist or designee will sign and date the
Packaging Component Specification form, returning all documentation to the
Process Engineer or designate to file.

6.3.2.1 The Process Engineer or designee will ensure all documentation
returned from Quality is approved with signature and date prior to
creating an electronic file.

e The Process Engineer will scan the verified documentation and
create an electronic file (PDF) including all required documentation
and save it to the original Packaging Component ID folder.

e The electronic copy of the data and specifications for this
documentation will be forwarded to the Quality Systems Manager.

e The original hardcopies of the approved documentation scanned
will be retained by the Process Engineer and available for reference.

6.4 Updating the Packaging Component Index for New Components

6.4.1 The Process Engineer or designee will update the Packaging Specification
Component Index to reflect the new component (to include Item ID, Category,
and description.

6.4.1.1 Based on the component type, the new component will be added and
saved to the corresponding spreadsheet. (F:/Doc — Control

Only/Technical Drawings and Specifications/Packaging Component
Specification Index).

6.4.1.2 A hardcopy of the Packaging Component Specification Index will be
updated, printed and stored in the designated Packaging Component
Specification binder as a reference guide for Quality, Production and
other departments (as applicable) each time a new packaging
component is added to the library.

6.5 Records will be retained per SOP C-502 (Record Storage, Retention, and Destruction).

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7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 06/14/18 | New procedure. N/A L. Erickson 8.0 Attachments | - | - |

8.1 Example of Packaging Component Specification Sheet — Bottle (PB)
8.2 Example of Packaging Component Specification Sheet — Cap (PC)

8.3. Example of Packaging Component Specification Sheet - Scoop (PK)

Attachment 1 - Example of Packaging Component Specification Sheet — Bottle (PB)

Packaging Component Specification
400cc Cobalt Blue PET Packer Round 45/400 Bottle

Specification Item Value
Height: 5.125 + .050

Width: 2.875 + .030

Mouth Opening: 1.631 +.015
Weight (gr): 37.3 & 2

Chemical Composition: PET
Color: Cobalt Blue

Suitability of Material: Confirmed

*Technical Drawing Attached from Paradigm Packaging

Ref. No. PBO175

Reviewed and Approved By:

QC Manager / Designate Date

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Attachment 2 - Example of Packaging Component Specification Sheet — Cap (PC)

Packaging Component Specification
Black Ribbed Mold-Rite Cap 45/400 Lift and Peel

Specification Item Value

Height: 0.445" + .010
Width: 1.865” +.010

Weight (gr): 39 £15
Chemical Composition: Polypropylene

Color: Black
Type: Ribbed with Smooth Top Cap Lift and Peel

Suitability of Material: Confirmed.
“Technical Drawing Attached from Mold-Rite Plastics Inc.

Ref. No. PCO153

Reviewed and Approved By:
QC Manager/ Designate Date

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Attachment 3 - Example of Packaging Component Specification Sheet—Desiccant (PK)

Packaging Component Specification
1.0 Gram Silica Gel Desiccant

Specification Item Value
Width: 0.9251" + .0787°

Length: 1.4960” +.0787

Net Weight 1.0gr + 10%
Packaging Type: Tyvek®

Composition: Silica Gel
Color: White

Suitability of Material: Confirmed
*Technical Drawing Attached from DryPak Industries

Ref. No. PKOLOS

Reviewed and Approved By:

Quality Managet/Designee Date