B-904

Packaging Procedure

Section B — Manufacturing Revision 10 13 pages

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1.0 Purpose

The purpose of this procedure is to outline all packaging processes performed at Ion labs, Inc.

2.0 Scope

This procedure applies to all packaging operations at Ion Labs, Inc.

3.0 Responsibility

3.1. It is the responsibility of Production (Packaging) Personnel to strictly follow this
procedure.

3.2 It is the responsibility of Production Management to implement this procedure and to
ensure that all involved personnel have been properly trained to follow this procedure.

3.3. It is the responsibility of QA Inspectors to ensure that this procedure is being followed.

4.0 Definitions

4.1 BPR — Batch Production Record

42 PITT -— Pallet Inspection Transfer Ticket

4.3 QA — Quality Assurance

4.4 PPE -—Personal Protective Equipment

4.5 CCP — Critical Control Point

46 eGMP-—Current Good Manufacturing Practices.
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5.0 References

5.1 A-108, SOP, Good Manufacturing Practices and Personal Hygiene

5.2 C-707, SOP, Critical Control Point Specifications

5.3. _B-905, SOP, Quality Control Inspection Process

5.4 C-105, SOP, Protocol and Report Documentation Requirements

5.5 E-803, SOP, Inspection of Palletized In-Process and Finished Product

5.6 B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment

5.7. G-207, SOP, Calibration Verification and Operation of Scales

5.8 C-707-F8, Form, CCP 5 — Blister Packaging Startup

5.9 C-707-F11, Form, CCP 8 — Pouch Packaging Startup

6.0 Procedure

6.1. Packaged Only Product Packouts

6.1.1 For packaged only batches, previously manufactured product is received and

issued as a raw material.

6.1.2 Premade product will be tested for microbial contamination at a minimum.

Additional testing will be performed as requested by the customer or as deemed
necessary by the QC Laboratory.

6.1.3 Single instance production runs of premade product will be managed through
protocol unless otherwise stated. Refer to SOP C-105 Protocol and Report

Documentation Requirements.

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6.2 Issuance and Return of Packaging Components

6.2.1 All required packaging components as outlined in the BPR must be collected

from the warehouse and issued to the batch.

6.2.2 After the packaging process has completed, all boxes containing packaging

components must be closed well by sealing the internal plastic bag, taping
closed the outer container, and/or securing plastic container lids. Once sealed,

Production must call a Warehouse employee immediately so that all components

can be returned electronically in Batchmaster and physically to the warehouse.

6.3 General Packaging Requirements

6.3.1 Ensure that all packaging areas, equipment, and utensils are clean and that all
appropriate cleaning has been documented as outlined in SOP B-111 Cleaning

of Manufacturing/Production Areas and Equipment.

6.3.2 If using a scale, ensure that the calibration has been verified and documented in

Redzone. Refer to SOP G-207 Calibration Verification and Operation of Scales.

6.3.3 Check the calibration stickers on all equipment that is to be used to ensure that

calibration has not expired. Report any expired calibration to the QA department
and remove the equipment from service.

Note: Do not use equipment with expired calibration.

6.3.4 Ensure that the packaging area is clear of all materials from the previous batch.
This includes, but is not limited to, the BPR, in-process materials, packaging

components, printed packaging, and associated documentation.

6.3.5 Identify the packaging room and equipment with a product detail tag.

6.3.6 Prior to the start of a packaging run, the operator and QA inspector must check
all materials and product containers for the following:

6.3.6.1 Check the material ID number against the BPR.

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6.3.6.2 Check the description of the material against the BPR.

6.3.6.3 Check the batch number against the BPR.

6.3.6.4 Ensure that the material has been released for use.

6.3.6.5 Ensure that the packaging components have been released or approved

by Quality for at risk use.

6.3.6.5.1 An issuance report must be generated prior to room startup

which outlines the release status of each lot of packaging
material to be used. The QC Laboratory must approve to

use at risk any lot of packaging material that is in

quarantine status.

6.3.6.6 The operator must verify that the quantity of material available is the

correct quantity for the production run.

Note: If any confirmation is not met, notify Production and Quality

Management.

6.3.7 If the entire quantity of any component is not in the packaging room at the

startup, operator must verify any subsequent delivery and notify QA inspectors
to perform additional verification. If a new lot of packaging material is issued to

the batch, a new issuance report must be generated and verified.

6.3.8 Personnel and visitors must follow cGMP guidelines as per SOP A-108 Good

Manufacturing Practices and Personal Hygiene. Personnel must follow all safety

precautions by wearing appropriate PPE.

6.3.8.1 Personnel must be garbed appropriately with frocks and/or lab coats,

hairnets, shoe covers and/or dedicated shoes, beard covers (if
applicable), dust masks, and gloves.

Note: For powder bottle filling areas only, gloves must be a
minimum thickness of 0.08mm. This should help to prevent

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contamination of the product due to ripped gloves during
the filling process.

6.3.9 All product (excluding certain liquid products) must pass through the metal
detector without indication of metal. Refer to SOP C-707 Critical Control Point

Specifications.

6.3.9.1 Liquid products are evaluated by product to determine if metal

detection can be performed. Due to the nature of some liquid form

products, metal detection cannot be performed.

6.3.10 All packaging procedures outlined in the BPR must be strictly followed.

6.3.11 During the packaging process, all reasonable precautions must be taken to
ensure that the packaging process does not contribute contamination from any

source.

6.3.12 If, during the packaging process, any problem with the packaging equipment

occurs, stop the machine and immediately notify the department supervisor to
take the necessary action.

6.3.13 The operator performing checks must record initials, date and time that checks
are performed and status of each check. If a check reveals an out of specification

result, a notation must be made in the BPR of actions taken to correct the issue.

6.3.14 All knives and cutting instruments are to be controlled, cleaned and well
maintained. Knives and cutting instruments will be cleaned once a week or

during scheduled room cleanings. These instruments will be only issued by the
Facility Manager.

6.4 For bulk packaging, follow the requirements that have been specified in the Packaging
Profile and BPR.

6.5 Bottling Procedure

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6.5.1 The operator performs four bottle checks at startup and every 60 minutes (+15
minutes) excluding shift downtime for breaks, etc. unless stated otherwise in the

individual batch record until the end of the bottling run to ensure product

quality.

6.5.2 The QA inspector performs an audit of the documents, the manufacturing area

to ensure compliance with the batch record and all applicable procedures.. Refer
to SOP B-905 Quality Inspection Process.

6.5.3 For tablets and capsules:

6.5.3.1 Verify the bottle count and ensure that the product in the bottle meets

all required quality standards.

6.5.3.1.1 Tablets must be consistent in size, color, and shape and

must be free of chips, breaks, capping, foreign matter, and
discoloration.

6.5.3.1.2_ Capsules must be fully locked and consistent in size, color
and powder quantity and must be free of folding, dimpling,

and tears.

6.5.4 For powders and liquids:

6.5.4.1 Verify bottle fill weight and ensure that the product in the bottle is free

of foreign matter and consistent in color.

6.5.5 For gummies:

6.5.5.1 Verify the bottle count and ensure the gummies are consistent in size,
color, shape, there is not a lot of excess on the sides, and they are free

of foreign matter.

6.5.5.2 Verify scale calibration and document in Red Zone. Gummy count will

be verified by weight.

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6.5.6 Ensure that the bottle contains space filler as specified.

6.5.7 Ensure that the bottle contains a desiccant or scent tab as specified.

6.5.8 Ensure that a neckband or clear full body sleeve is present and correctly oriented
as specified.

6.5.9 Ensure that the cap is threaded and sealed properly. Perform cap torque test as
specified in the BPR.

6.5.10 Complete the yield calculation reconciliation in the BPR. Move the packaged
product to the designated area until the product is released for shipment or

further processing by QA inspector.

6.6 Blistering Procedure

6.6.1 Ensure that Form C-707-F8 CCP 5 — Blister Packaging Startup has been

completed and approved before starting the run.

6.6.2 The packaging operator performs three blister checks at startup and every 60

minutes (+15 minutes) unless stated otherwise in the individual batch record
until the end of the blistering run to ensure product quality.

6.6.3 The QA inspector performs an audit of the documents, the manufacturing area
to ensure compliance with the batch record and all applicable procedures. Refer

to SOP B-905 Quality Inspection Process.

6.6.3.1 Verify the blister count and ensure that the product in the blister meets

all required quality standards.

6.6.3.1.1 Tablets must be consistent in size, color, and shape and

must be free of chips, breaks, capping, foreign matter, and

discoloration.

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6.6.3.1.2 Capsules must be fully locked and consistent in size, color
and powder quantity and must be free of folding, dimpling,

and tears.

6.6.3.2 Ensure that the blister cavities are formed uniformly and the foil is

sealed with dots notably distinguished and even from each side of the

blister cavity.

6.6.3.2.1 Operator will perform a blister submersion leak test at

startup and during routine inspections of the blistering
process.

6.6.3.3 Ensure that all required blister coding is legible and correct.

6.6.3.4 Complete the yield calculation reconciliation in the BPR. Notify the

Warehouse for them to move the packaged product to the designated
area until the product is released for shipment or further processing by

QA.

6.7 Pouching Procedure

6.7.1 Ensure that Form C-707-F11 CCP 8 — Pouch Packaging Startup has been
completed and approved before starting the run.

6.7.2 The packaging operator performs three pouch checks at startup and every 60
minutes (+15 minutes) excluding shift downtime for breaks, etc. unless stated

otherwise in the individual batch record until the end of the pouching run to

ensure product quality.

6.7.3 The QC inspector performs an audit of the documents, the manufacturing area to

ensure compliance with the batch record and all applicable procedures Refer to
SOP B-905 Quality Inspection Process.

6.7.4 For tablets and capsules:

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6.7.4.1 Verify the pouch count and ensure that the product in the pouch meets
all required quality standards.

6.7.4.1.1 Tablets must be consistent in size, color, and shape and
must be free of chips, breaks, capping, foreign matter, and

discoloration.

6.7.4.1.2 Capsules must be fully locked and consistent in size, color
and powder quantity and must be free of folding, dimpling,

and tears.

6.7.5 For powders and liquids:

6.7.5.1 Verify pouch fill weight and ensure that the product in the pouch is
free of foreign matter and consistent in color.

6.7.6 Ensure that the pouches are formed uniformly and the pouch has no large
wrinkles or other visual defects. Pouches must be fully sealed on all sides and

properly aligned on all corners.

6.7.7 If needed, a packaging operator or QA inspector will perform a submersion leak

test at startup and during routine inspections of the pouching process. Ensure
that all required pouch coding is legible and correct.

6.7.8 Complete the yield calculation reconciliation in the BPR. Move the packaged

product to the designated area until the product is released for shipment or
further processing by QA.

6.8 Labeling, Shrink Sleeving, and Cartoning Procedure

6.8.1 All labels, shrink sleeves, cartons, and display trays must be released by Label

Control and issued by the Warehouse, and must be the correct item for the job.

6.8.2 All label and carton part numbers must be verified against the BPR.

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6.8.3 A representative sample of the item that is to be used must be affixed in the
BPR and confirmed by QA before the packaging process begins.

6.8.3.1 For Labels, Each time a new spool is added to the line, a representative
sample from the spool will be examine to ensure it is the correct label

and must be affixed to the batch record with the operator’s initials and

date and time.

6.8.4 Labeling instructions stated in the BPR must be strictly followed.

6.8.5 The packaging operator performs four checks at startup and every 60 minutes
(£15 minutes) excluding shift downtime for breaks, etc. unless stated otherwise

in the individual batch record until the end of the run to ensure product quality.

6.8.6 The QA inspector performs an audit of the documents, the manufacturing area

to ensure compliance with the batch record and all applicable procedures Refer
to SOP B-905 Quality Inspection Process.

6.8.7 At the end of bottling, labeling and/or cartoning lines, packaging personnel will
visually examine each unit for conformance as detailed below:

6.8.7.1 Bottled product is 100% visually inspected to ensure coding is legible,
the batch number is present and correct, and shelf life is present and

correct as required by BPR

6.8.7.2 Bottled product is 100% visually inspected for label or shrink sleeve
presence on the bottle with no visible wrinkles, and proper orientation

on the bottle (refer to Attachment 1 for label orientation).

6.8.7.3 Bottled product is 100% visually inspected for the presence of a

neckband or clear full body sleeve as applicable.

6.8.7.4 Cartoned product is 100% visually inspected to confirm carton integrity

and elegance. An insert will also be confirmed at this time and if
applicable.

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6.8.8 A copy of the product coding must be made and placed in the associated BPR.

6.8.9 Complete the yield calculation reconciliation in the BPR. Notify QC and move

the packaged product to the designated area until the product is released for
shipment by QC. Pallets should be identified with Hold — Pending Release tags.

6.9 Tertiary Packaging and Palletizing

6.9.1 Product will be packed into a master case outlined in the BPR and a master case

label will be applied.

6.9.2 Generic master case labels are generated by Production Control personnel and
contain the following information at a minimum:

6.9.2.1 Batch number

6.9.2.2 Product name

6.9.2.3 Shelf life

6.9.2.4 Quantity per master case

6.9.3 Customer specific master case labels are generated by Quality Assurance
personnel and contain information provided by the customer and outlined in the

Packaging Profile and on the Shipping Label Request Form (as applicable).

6.9.4 Master case and pallet labels must be reviewed and approved prior to being

applied and a representative sample must be placed in the BPR.

6.9.5 Master cases will be placed onto the pallet as outlined in the BPR and all special

palletizing instructions must be followed.

6.9.6 The pallets should be properly identified by a PITT that includes the product

name, customer name, batch number, pallet number(s), and quantity. Refer to
SOP E-803 Inspection of Palletized In-Process and Finished Product.

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6.9.7 Each original white copy of the PITT will be placed in the BPR for
accountability.

6.10 After the completion of the production run, cleaning of the room/area and equipment
must be performed according to the appropriate procedures and documented as outlined

in SOP B-111 Cleaning of Manufacturing/Production Areas and Equipment.

6.11 Final release of the batch will be dependent on product meeting all required finished
product specifications as outlined on the finished product test ticket.

7.0 Revision History CCR #

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 2 | 07/21/14 | 7.9.1.1.2, and 7.12. Added section 7.8, Changed QC inspection from 30 minutes to hour. | 14-0584 | V. Iltcheva |
| 3 | 06/18/15 | Added PITT requirements. Added requirements for material confirmation. | 15-0524 | E. Cummings |
| 4 | 03/10/16 | Added reference to cutting instruments and knives. | 16-0216 | S. Millar |
| 5 | 11/10/16 | Added requirements to verify any materials brought to packaging rooms. Added inspection sheet. 77g Tt Scheduled review: complete rewrite. 19-0660 K. Burris | 16-0826 | E. Hasanbasic |
| 7 | 08/02/21 | Added gummy bottling procedure. CC- | 21-0307 | K. Blozousky |
| 8 | 10/07/21 | Added note in step 6.3.7.1 to specify glove requirements. CC- Updated procedure to reflect current practices. Added additional | 21-0376 | K. Burris |
| 9 | 05/20/22 | definitions and references. Updated format and logo. CC- 1. Updated Header with current Logo 2. Update references to QC and QC inspectors to QA as appropriate 3. Update 6.5.2, 6.7.3, and 6.8.5 to change the hourly checks to and audit of the dpcuments 4. Update 6.7.7 to include a packaging operator as party that may perform cheel 5. Update 6.8.2 to include part before number 10 ovr il3pdate 6.8.7 to specify personnel responsibilities at the end of varioub CC_25-9277 S. Orlovic packaging lines and add “as required by BPR” 7. Update 6.9.3 to read Quality Assurance 8. Update 6.5.1, 6.6.2, 6.7.2 and 6.8.5 to 60 minutes unless specified in BPR 9. Update 6.3.6.5 to specify Quality will release packaging components 10. Remove “and QA inspector” from 6.3.13 and update 6.6.3.2. ] to operator 1 Update 65-52 i f-te-d: inRed. te-specify-te-doeumentin Red Zone 12. Update 6.6.3.4 to change from notify OA to WH 8.0 Attachments 8.1 Attachment 1 — Example of Correct Label Orientation | 22-0220 | K. Blozousky |

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Attachment 1 — Example of Correct Label Orientation

- Too High Centered Too Low