B-905
Quality Inspection Process
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1.0 Purpose
The purpose of this procedure is to provide direction for quality inspection of products during
the manufacturing/packaging process for products manufactured by Ion Labs, Inc.
2.0 Scope
This procedure is applicable to the inspection of products manufactured and packaged by Ion
Labs, Inc. The procedure applies to inspections conducted by the quality department as well as
production personnel to ensure and monitor product quality.
3.0 Responsibility
3.1 ‘It is the responsibility of Production personnel to:
3.1.1 Follow this procedure during production inspections, cleaning activities, and
startup activities.
3.2 ‘It is the responsibility of QC Inspectors to:
3.2.1 Follow this procedure during QC audits, cleaning activities, and startup
activities as applicable.
3.2.2 Report observed risks to Quality Management.
3.3 It is the responsibility of Quality Management to:
3.3.1 Assess risks and distribute quality resources appropriately.
3.3.2 Approve corrective action to Alert Observations.
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3.3.3. Approve AQSD.
3.4 It is the responsibility of Production Management to:
3.4.1 Establish and execute corrective action to Alert Observations.
3.4.2 Approve AQSD.
3.4.3. Ensure that production personnel follow inspection processes identified in
manufacturing and packaging batch records.
4.0 Definitions
4.1 Alert Level Observations — an observation that meets acceptance limits but is not well
centered or would benefit from action in order to maintain acceptable product
4.2 Action Level Observation — an observation that is outside of acceptance limits or
otherwise requires action before product is acceptable
4.3 BPR - Batch Production Record
4.4 Inspection — an inspection or check conducted by Production and/or Quality personnel
4.5 Interval Based Inspection — inspection or check conducted at specific intervals
4.6 Inspection/check — both terms refer to the act of evaluating product quality, adherence
to procedure, and/or conformance to established specifications, and are used
interchangeably in this procedure
4.7 AQSD — Approved Quality Standard Definition; a quality standard defined in writing
outside of a batch and approved by signature according to the formatting requirements
of this procedure
4.8 AQL — Acceptance Quality Limit; the maximum number of defective units, beyond
which a batch is rejected
4.9 QC — Quality Control
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4.10 PDT — Product Detail Tag
4.11 Redzone (RZ) — a software application used to collect data during the production
process; used to track production data, as well as cGMP data
4.12 Data Sheet — an RZ component of the RZ Compliance Module, configured to collect
data
4.13 PQC — Process Quality Check: Details are provided within this procedure
4.14 PQV — Process Quality Verification: Details are provided within this procedure
4.15 Critical Defect — Any condition found which poses the possibility of causing injury of
harm to, or otherwise endangering the life or safety of, the end user of the product or
others in the immediate vicinity of its use.
4.16 Major Defect — Any condition found adversely affecting the product’s marketability
and sale-ability or adversely affecting its required form, fit, or function, and which is
likely to result in the end user returning it to the source from which purchased for
replacement or refund.
4.17 Minor Defect — Any condition found which while possibly less than desirable to the
end user of the product, does not adversely affect its required marketability, sale-ability,
form, fit, or function and is unlikely to result in its return to the source from which
purchased.
5.0 References
5.1 B-905-F1, Form, QC Audit Form
3.2 B-905-F2, Form, AQL — Inspection Form for Critical Defects
5.3 B-905-F3, Form, AQL — Inspection Form for Major Defects
5.4 B-905-F4, Form, AQL — Inspection Form for Minor Defects
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30 B-905-F5, Form, AQL — Inspection Form
5.6 B-108, SOP, Reprocessing Procedure
3.7 B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment
5.8 E-704, SOP, AQL Statistical Sampling Plan
a9 21 CFR part 111, 114, 117, 210, 211 - as applicable to Dietary Supplements, Cosmetics
and OTC (reference FDA CFR - Code of Federal Regulations Title 21 for specific part
reference)
5.10 C-104, SOP, Master Batch Record and Issuance of Batch Production Record
3.11 C-111, SOP, Redzone General Use
5.12 C-109, SOP, Redzone Operator Activities
5.13 C-110, SOP, Redzone QC Inspector Activities
5.14 C-107, SOP, Redzone Reviewer Activities
5.15 C-201, SOP, Deviation and Investigation Procedure
6.0 Process Overview
6.1 The BPR for each product defines required Quality Inspections. This SOP defines
standardized default inspection parameters. The BPR follows these standards unless the
customer, or product development / experience dictate other inspection requirements.
In either case, the inspection process defined by the BPR takes precedence over the
inspection process defined by this procedure.
6.2 SOP C-104 Master Batch Record and Issuance of Batch Production Record controls the
issuance of the BPR. SOP C-104 defines forms for recording Quality Inspection
activities and associated data customized to specific product Master Batch Records.
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Additionally form(s) associated with this procedure provide the mechanism to record
Quality Audit activities and associated data.
6.3 Forms provided by SOP C-104 Master Batch Record and Issuance of Batch Production
Record and B-905 Quality Inspection Process provide detailed instructions for
Inspections. These forms may be available in Redzone. The forms provided also serve
as a backup documentation option if the Redzone data sheets are not available for use.
Use Redzone data sheets as the preferred method for recording inspections / audits if
available. When Redzone data sheets are not available, use the associated forms.
6.4 NOTE: Redzone is a software application used to collect data during the production
process. Redzone is not available for all data collection. The use of Redzone requires
verification activities covered by SOP C-107 Redzone Reviewer Activities prior to use
in our facility.
7.0 PQC — Process Quality Check
7.1 A PQC is a process quality check. PQC activities include but are not limited to:
e Room Startup Checks as defined by the BPR and described later in this SOP
e Metal detector operational verification.
e Interval based inspections as defined by the BPR and described later in this SOP
72 Any qualified individual may complete a PQC. Production operators typically
complete PQC activities. | QC Inspectors may also complete a PQC; however, QC
Inspectors usually perform this function as part of the QC Audit.
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8.0 PQV- Process Quality Verification
8.1 A PQV is a process quality verification. A PQV is necessary for critical activities that
require documentation of the completion of an activity (i.e. a PQC) as well as the
verification of that activity (i.e. a PQV). Examples of PQV activities include but are
not limited to:
e Room startup readiness verification
e Metal detector operational verification
e Verification of cleaning effectiveness
8.2 Production leads, production management, and QC Inspectors complete PQV activities.
QC Inspectors may perform a PQV function as part of the QC Audit after a PQV is
already completed. Any qualified individual may complete a PQV; however, a different
person than the one completing a corresponding PQC for the same activity must
complete a PQV.
9.0 QC Audits
9.1 Quality Control conducts regular audits of production activities using form B-905-F1 or
Redzone audit forms as applicable. Audits conducted in Redzone are available through
the Redzone interface and Power BI reports. DC files audits conducted on form B-905-
Fl. NOTE: Redzone audit forms will collect all the same information indicated on
form B-905-F1, but may collect additional information.
9.2 Ideally, QC conducts audits of each area actively in production three times per shift.
This frequency may vary depending upon:
e The risk of the production activity
e The risks imposed by the product under production
e The length of time activity is underway during that shift
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9.3 QC Audits provide the following functionality:
e Inspection of the quality of product produced.
e Accountability for those conducting PQC and PQV functions.
e Direction to Production personnel for corrective actions to observed defects
10.0 Interval Based Inspections
10.1 The BPR defines inspection actions (i.e. PQC and PQV activities) and intervals for
those inspections.
10.2 The table below lists default inspections. The default time interval for inspections is 60
minutes.
Inspection
Tableting (e.g. weight, thickness, hardness, etc.)
Encapsulation (e.g. weight, capsules locked, etc.)
Liquid Fills
Powder Fills
Gummy (e.g. weight)
Bottling (e.g. product quality, space filler, desiccant, cap seal integrity, neckband, etc.)
Labeling (e.g. batch # legible and correct, shelf life legible and correct, Julian lot
legible and correct, bottle label present and correctly oriented, etc.)
Cartoning (e.g. batch # legible and correct, shelf life legible and correct, Julian lot
legible and correct, bottle label present and correctly oriented, etc.)
Metal Detection
11.0 Interval Based Inspection Documentation
{Ld When using Redzone datasheets to record interval based checks, Redzone may be
programed to interpret intervals as the amount of time the line is running. This allows
Redzone to automatically account for down time due to breaks or stoppage of the line.
Rezone may also be configured to initiate checks based on elapsed time. The
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appropriate configuration of Redzone occurs during the development and verification of
the datasheet as covered by SOP C-107.
1.2 When using paper forms to record interval based checks, interpret the intervals as
elapsed time unless there is documented down time as described later in this section.
11.3 Where a time/date entry is required for an inspection, the following list defines
parameters for documenting those inspections.
11.3.1 Enter the date/time that represents the date and time the inspection was
completed.
11.3.2 Complete the inspection entry immediately after the completion of the
inspection.
11.3.3 Interval based inspections are on time if the inspection is within the allowed
interval (table below) from the previous inspection time, excluding production
downtime. More frequent inspections (i.e. shorter time intervals than required)
are allowed. SOPs and / BPRs may dictate specific allowances other than those
listed here.
Interval Allowed Interval
Less than or equal to 30minutes + 10 minutes
More than 30 minutes +15 minutes
11.3.4 In the event that an interval based inspection is performed outside of the
required time allowance, a deviation must be initiated as per SOP C-201
Deviation and Investigation Procedure.
11.3.5 When using paper forms to document an inspection, follow these documentation
practices.
11.3.5.1 Unless specific values are required (i.e. length, thickness, hardness,
weight, use a check mark (“) entry to indicate that an inspection was
completed and that the subject of the inspection met all expectations.
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11.3.5.2 Use a check mark with a comment (WY) entry to indicate that the
inspection was completed and that an action observation occurred.
The “®” above is a note or footnote to document the action
observation in the BPR.
11.3.5.3 Document production downtime if it is longer than 15 minutes. Use a
comment on the time entry following the downtime or write across one
column of inspection boxes with an indication of the down time
reason. Examples of downtime include:
° Lunch
° Break
° Maintenance/Repair (add detail as applicable)
11.3.6 Example paper form based inspection documentation is available as attachments
in Section 15.0.
12.0 Room/Equipment Cleaning Inspections
12.1 SOP B-111 Cleaning of Manufacturing/Production Areas and Equipment provides
details for cleaning equipment and production areas.
12,2 SOP B-111 Cleaning of Manufacturing/Production Areas and Equipment also provides
details for inspection and verification of those processes.
12.3 This provides a summary here only for references. Details provided in SOP B-111
Cleaning of Manufacturing/Production Areas and Equipment supersede any details
provided herein.
12.4 Production personnel are responsible for completing cleaning activities and PQC /
12.5 Production leads, production management, and QC Inspectors complete PQV activities
as described in section 8.0 of this SOP.
12.6 Quality Inspectors are responsible for auditing cleaning activities.
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12.7 In general, PQC / PQV activities include:
12.7.1 Ensure that the room/ line / equipment is clean and suitable for use.
12.7.2 Ensure that required room / line / equipment tags correctly identify the cleaning
status.
12.7.3 Ensure that cleaning documentation has been completed properly and reflect the
status of the room / line / equipment.
13.0 Startup Inspections
13.1 In addition to any specific startup checklist / instructions listed in the batch record,
production personnel must complete and confirm completion of the following list:
13.1.1 Ensure that the room and equipment is clean and suitable for use.
13.1.2 Ensure that cleaning documentation is appropriate for the intended use of the
current production activity.
13.1.3 Ensure that required room / line / equipment tags have the correct PDT, which
identifies the intended activity.
13.1.4 Ensure that the materials / components intended for use are released or approved
by the QC Laboratory to be used at risk, and that ID codes match those called
out in the BPR.
14.0 Defect Categorization
14.1 This section defines common potential defects as Critical, Major, or Minor based on the
definitions provided at the beginning of this SOP and repeated herein. Interpretation of
these definitions is required in classifying defects, and as there are potentially other less
common defects, the BPR may define other classifications and/or AQL assignments.
Defect categorization and AQL levels defined in the BPR supersede those defined in
this SOP.
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14.2 In general, AQL categories are set as follows:
AQL Category Definition AQL
Any condition found which poses the possibility of causing injury of
Critical harm to, or otherwise endangering the life or safety of, the end user of 0.10
the product or others in the immediate vicinity of its use.
Any condition found adversely affecting the product’s marketability and
Maior sale-ability or adversely affecting its required form, fit, or function, and 0.65
J which is likely to result in the end user returning it to the source from :
which purchased for replacement or refund.
Any condition found which while possibly less than desirable to the end
Minor user of the product, does not adversely affect its required marketability, 25
sale-ability, form, fit, or function and is unlikely to result in its return to .
the source from which purchased.
Product / Defect AQL
Process Category
Foreign Materials on the inside of a container that is in contact with ws
Critical
Any
product
Packaging | Any labels that are missing, illegible, ripped, or torn Critical
Packaging aa container that has missing, burnt, or not fully adhered inner induction Critical
Packaging Any product with missing, incorrect, illegible, or overlapping traceability Critical
marks (e.g. expiration dates, lot numbers)
Any Foreign Materials on the outside of a container and not in product contact Major
. Any labels that are wrinkled, folded, doubled, or misaligned, but that are .
Packaging : : Major
still legible
‘ Any container that has missing, loose, detached, or broken outer neckband ,
Packaging arceal Major
. Any scuffed, smudged, or ink spot marks on the container. Any dented or .
Packaging ; : Major
damaged primary packaging components (bottles / caps)
Packaging | Any product with quantities short of specification ranges Major
Capsules Product Quality- folding, dimpling, tears, completely locked with Minor
consistent size, color and shape
Surface Erosion, Edge Erosion, Breakage, Film Cracking, Orange Peel
Tablets Roughness, Color Variation, Black Specs, Logo Bridging, Twinning, Minor
Peeling, Spray Drying, Picking and Sticking, Tablet to Tablet Color
Variation, Other
Packaging | Any product with quantities that exceed specification ranges Minor
Packaging | Any missing components such as desiccant or scoop Minor
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15.0 Final Step AQL Inspections
15.1 The “Final Step” inspection applies to product after the final step of the applicable
production operation is complete. It is acceptable to pull final step samples earlier in the
operation to avoid unnecessary destructive testing. For example, it is acceptable to pull
bottle samples after filling but before capping to avoid the destructive operation of re-
opening the bottle and destroying induction seals or labels.
15.2 Final Step AQL Inspections are part of QC Audits. The use of AQL inspections may
provide supporting data for responses to operational issues and/or observed defects
outside of QC Audit observations.
15,3 SOP E-704 AQL Statistical Sampling Plan provides instructions for conducting AQL
inspections. QC Inspectors may provide direction for Production execution of AQL
inspections in response to a QC Audit finding.
15.4 In general, AQL categories and levels apply to an entire batch. Base sampling plans
and acceptance criteria on the full batch size. When conducting in-process inspections
and/or evaluating a portion of a batch, choose a sampling plan based on the sub-set
quantity understanding that this represents a worst-case scenario.
13.5 Failure of an AQL inspection does not necessarily result in rejection of product, but
may point to activities or steps to correct identified defects.
16.0 Final Step General Inspections
16.1 The “Final Step” inspection applies to product after the final step of the applicable
production operation is complete. It is acceptable to pull final step samples earlier in the
operation to avoid unnecessary destructive testing. For example, it is acceptable to pull
bottle samples after filling but before capping to avoid the destructive operation of re-
opening the bottle and destroying induction seals or labels.
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16.2 Final Step General Inspections are part of QC Audits. These general inspections are
similar to an AQL inspection; however, this general inspection does not apply AQL
statistics to determine sample size or accept / reject levels.
16.3 General Inspections assume a zero tolerance for Critical and Major defects. Acceptance
of minor defects is based on the discretion of the QC Inspector. Ultimately, the goal of
the inspection is to ensure that the finished product would meet all applicable AQL
limits if an AQL inspection were applied to the complete batch.
16.4 Failure of an AQL inspection does not necessarily result in rejection of product, but
may point to activities or steps to correct identified defects.
17.0 Action Observations
17.1. Action observations are observations that are outside of acceptance limits and otherwise
require action before the product is acceptable. Document action observations in the
BPR with a comment for the inspection documentation.
18.0 Alert Observations
18.1 Alert observations are observations that meet acceptance limits but are not centered or
would benefit from action in order to maintain acceptable product. It is not necessary to
add a comment on alert observations in the BPR.
19.0 Correction of Action Observations
19.1 Quality Management and Production Management must collaborate to determine how
to correct observations of product that is outside of acceptance limits or that otherwise
requires action to meet quality standards. Identify the cause of the observation and then
the scope of the product impacted by that observation (see further discussion in Section
19.2 below). If there is no correction plan identified, then reject or mark as waste any
product that fails to meet acceptable standards. If there is a correction plan identified
(see further discussion in Section 19.3 below), then execute that plan and disposition
product accordingly.
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19.2 Determine Observation Scope
19.2.1 Based on the identified cause of the observation, it may be possible to limit the
product evaluation and/or correction plan to a portion of the batch or a period of
production activity. Conduct additional inspection as applicable to determine the
scope of the observation. The following are typical inspection practices:
19.2.1.1 Inspection of a pallet (i.e. layer by layer)
19.2.1.2 Inspection back to the last good check
19.2.1.3 Inspection of a subpart of a batch (i.e. one pan, barrel, bucket)
19.2.2 Consider using AQL sampling (covered in SOP E-704 AQL Statistical
Sampling Plan) or other statistical approaches to evaluate the observation.
19.3. Correction Plan
19.3.1 Document the correction plan in a protocol as directed by SOP B-108
Reprocessing Procedure unless the plan meets the following criteria:
19.3.1.1 The correction activity does not require inspection or processing other
than that already defined by the applicable BPR.
19.3.1.2 The BPR that contains the correction steps is still open and the product
is still in the same room or stationed next to the same line used to
process those steps in the BPR.
20.0 Quality Standards
20.1 Where possible, establish quality standards in the BPR for each specific product.
Numerical standards (i.e. weight, thickness, hardness, torque) are easy to describe
within the record. Descriptive standards (i.e. cosmetic defects like wrinkles, spots,
legible coding) benefit from examples to describe what is and is not acceptable. Some
standards may differ from product to product based on customer expectations —
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especially those standards associated with product and / or packaging elegance. Where
possible, define descriptive quality standards as clearly as possible using an AQSD.
20.2. AQSD Document Format
20.2.1 Format an ASQD as needed such that the definition of the standard is clearly
communicated. If pictures are included, color printouts may be necessary. If
physical standards are necessary, use an ASQD document as described here to
reference those physical standards.
20.2.2 An AQSD document must have at minimum the following pieces of
information:
20.2.2.1 Indication of the scope the standard applies to (for example):
° General production — default standard for all similar
production activities
° Specific product — a standard established for a specific
product
° Specific campaign — a standard established for a specific
period of time
e Specific batch — a standard that only applies to a specific
batch or listed batches
20.2.2.2 Description of the standard that is defined
20.2.2.3 Definition of the standard
20.2.2.4 Required signatures and signature dates
e Quality Management
e Production Management
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20.2.2.5 If applicable, an AQSD document should address the following:
° The reason for tightening or loosening a current AQSD.
e AQL Inspection Level and Limit used if an AQL inspection
is required and is associated with the AQSD.
° Reference to customer approval of the AQSD.
° Customer approval Signature and/or Ion Account Manager
Signature, representing customer approval of the AQSD.
20.2.3 AQSD Document Filing/Use
20.2.3.1 DC files and maintains all official AQSD documents. Make copies of
AQSD documents that apply to general use available to Production and
Quality personnel (i.e. in binders near applicable activities). Make
copies of AQSD documents that are specific to products, campaigns,
or specific batches available with the applicable BPRs.
21.0 Revision History
| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 06/17/19 | New procedure. N/A K. Burris | - | - |
| 1 | 08/10/21 | ane reference to CFR. Added Gummy to interval based inspection CC- | 21-0319 | C. Mitchell |
Removed incremental inspections for QC inspectors. Removed
2 Benehine t a h t r t o a u c g h h m o e u n t t . 3 U . p R d e a m t o ed v e l d og s o e c a t n i d o n f o 8 r . m 1 a 2 t . . C R la e r m if o i v e e d d p r p o o c r e t d i u on r s e of risk- Cer A e i a : r aae kK Bums .
based inspection activities.
Re-write of procedure to define Process Quality Check (PQC) and
3 01/09/23 | Process Quality Verifications (PQV) and clearly define the QC CC-23-0009 D. Herd
Inspectors’ responsibilities for production audits.
22.0 Attachments
aaah Attachment 1 — Interval Based Inspection Documentation Example
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Attachment 1 — Interval Based Inspection Example
Interval Based Inspection
ae re ne pe ae Comment About This Example
Activity 1 4 v v ve v N/A
Activity 2 v v¥@ v v v N/A
Activity 3 v v v vel v N/A
@Comment explaining late interval with initials and date.
@®Comment explaining action observation during inspection with initials and date.
[SOP
IAN LABS QC Audit Form
Form: B-905-F1 CCRNo. CC-23-0009 Revision: 0
Audit Information
Location Date / Time
Lot # Product Name
QC Audit Activities Summary
Activity Comment Result
Final Step AOL CI N/A (C See Below CI Pass
I eee Q e Document AQL Inspection(s) on forms B-905 AQL Inspection forms as applicable. C Fail
nspection Summari : z e those i : nspecti : ons here. ON/A
= CIN/A (See Below Op
Final Step e Unit inspected (e.g. case, bottle, tablet, etc.) oe
General es . C) Fail
faencctina e # of units inspected:
P © # of units that fail CN/A
LIN/A (© See Below
Pass | Fail | N/A GMP Fundamental
GMP O} O C1 | Labels / Signs C] Pass
Fundamentals oO oO O | Temporary Fixes CO) Fail
O | O | © | GMP Gowning CN/A
O 0 1 ‘| Cross contamination requirements followed (e.g. doors closed)
POC / POV OON/A (See Below details about PQC(s) that were re-checked. O Pass
C) Fail
Re-check
OON/A
CUN/A OC See Below CO Pass
Other C) Fail
LUN/A
OUN/A (See Below CJ Pass
Other C Fail
CU N/A
Note: N/A indicates that the activity does not apply or was not completed in this audit.
Audit Supporting Information (notes, comments, references)
CUN/A OC See Below
Audit Actions (none or all actions that apply)
C1 None C1] Initiate Product Inspection
C] Other — as described in supporting information
Name Title Signature Date
Completed By:
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IANLABS AQL -Inspection Form for Critical Defects
Form: B-905-F2 CCRNo. CC-23-0009 Revision:
AQL Inspection Subject
Lot # Product Name
Unit Type # of Units
Location Date / Time
Critical Level Inspection Parameters
AQL 0.10 Sample Size Ac Limit Re Limit
Based on the number of “units” contained in the batch or portion of the batch under inspection, determine and record the inspection
arameters for this AQL. NOTE: “Ac Limit” = Accept Limit and Re Limit = “Reject Limit.”
Pass — Pass — Inspected | Fail— Inspected and | N/A —Not
Inspected and and defects defects found the applicable
Defect no defects found that meet | exceed or equal the or not
Defect Count found the accept limits reject limits inspected.
Any: Foreign Materials on the inside of a o og o c
container that is in contact with product
Packaging: Labels that are missing,
illegible, ripped, or torn 0 O a 0
Packaging: Container that have missing,
burnt, or not fully adhered inner induction oO O | mi)
seal
Packaging: Product with missing,
incorrect, illegible, or overlapping
traceability marks (e.g. expiration dates, O So 0 Fl
lot numbers)
LJ N/A or C1 Other (specify)
Oo O Es O
C] N/A or C] Other (specify)
Oo Oo Oo Oo
C1 N/A or ( Other (specify)
O El O Oo
CJ N/A or C Other (specify)
Oo O O O
Inspection Supporting Information (notes, comments, references)
OON/A OC See Below
Inspection Actions (none or all actions that apply)
C] None C1] Initiate Additional Product Inspection
C1 Initiate Re-work of product. Reference re-work protocol or describe in supporting information
CZ Reject product. Reference or provide details in supporting information
C Other — as described in supporting information
Name Title Signature Date
Completed By:
[SOP
JAN LABS AQL — Inspection Form for Major Defects
Form: B-905-F3 CCRNo. CC-23-0009 Revision:
AQL Inspection Subject
Lot # Product Name
Unit Type # of Units
Location Date / Time
Major Level Inspection Parameters
AQL 0.65 Sample Size Ac Limit Re Limit
Based on the number of “units” contained in the batch or portion of the batch under inspection, determine and record the inspection
arameters for this AQL. NOTE: “Ac Limit” = Accept Limit and Re Limit = “Reject Limit.”
Pass — Pass — Inspected | Fail—Inspected and | N/A —Not
Inspected and and defects defects found the applicable
Defect no defects found that meet | exceed or equal the or not
Defect Count found the accept limits reject limits inspected.
Any: Foreign Materials on the outside of
a container and not in product contact O ~ a Ss
Packaging: Labels that are wrinkled,
folded, doubled, or misaligned, but that O O O Oo
are still legible
Packaging: Container that has missing,
loose, detached, or broken outer O oO O |
neckband or seal
Packaging: Scuffed, smudged, or ink spot
marks on the container. Any dented or g oO O gO
damaged primary packaging components
(bottles / caps)
Packaging: Product with quantities short
of labeled claims Oo Oo O O
C] N/A or C Other (specify)
O O O O
C) N/A or CO Other (specify)
O O O O
C] N/A or C) Other (specify)
O O O O
Inspection Supporting Information (notes, comments, references)
CI N/A (CI See Below
Inspection Actions (none or all actions that apply)
C) None C Initiate Additional Product Inspection
C1 Initiate Re-work of product. Reference re-work protocol or describe in supporting information
CZ Reject product. Reference or provide details in supporting information
(J Other — as described in supporting information
Name Title Signature Date
Completed By:
[SOP
IANLABS AQL — Inspection Form for Minor Defects
Form: B-905-F4 CCRNo. CC-23-0009 Revision: 0
AQL Inspection Subject
Lot # Product Name
Unit Type # of Units
Location Date / Time
Minor Level Inspection Parameters
AQL 2.5 Sample Size Ac Limit Re Limit
Based on the number of “units” contained in the batch or portion of the batch under inspection, determine and record the inspection
arameters for this AQL. NOTE: “Ac Limit” = Accept Limit and Re Limit = “Reject Limit.”
Pass — Pass — Inspected | Fail—Inspected and | N/A-— Not
Inspected and and defects defects found the applicable
Defect no defects found that meet | exceed or equal the or not
Defect Count found the accept limits reject limits inspected.
Capsules: Product Quality- folding,
dimpling, tears, completely locked with EB O O O
consistent size, color and shape
Tablets: Surface Erosion, Edge Erosion,
Breakage, Film Cracking, Orange Peel
Roughness, Color Variation, Black Specs, q q a 4
Logo Bridging, Twinning, Peeling, Spray
Drying, Picking and Sticking, Tablet to
Tablet Color Variation, Other
Packaging: Any product with quantities
that exceed label claims = A a ea
Packaging: Any missing components q oO o oO
such as desiccant or scoop
1 N/A or C) Other (specify)
O O O O
C] N/A or C) Other (specify)
O Oo O O
CJ N/A or C] Other (specify)
O O O O
Inspection Supporting Information (notes, comments, references)
CUN/A C See Below
Inspection Actions (none or all actions that apply)
C None C1 Initiate Additional Product Inspection
CJ Initiate Re-work of product. Reference re-work protocol or describe in supporting information
C Reject product. Reference or provide details in supporting information
C1 Other — as described in supporting information
Name Title Signature Date
Completed By:
(Author)
[SOP
IAN LABS AQL -Inspection Form
Form: B-905-F5 CCRNo. CC-23-0009 Revision:
AQL Inspection Subject
Lot # Product Name
Unit Type # of Units
Location Date / Time
Critical Level Inspection Parameters
AQL Sample Size Ac Limit Re Limit
Based on the number of “units” contained inthe batch or portion of the batch under inspection, determine and record the inspection
arameters for this AQL. NOTE: “Ac Limit” = Accept Limit and Re Limit = “Reject Limit.”
Pass — Pass — Inspected | Fail—Inspected and | N/A — Not
Inspected and and defects defects found the applicable
Defect no defects found that meet | exceed or equal the or not
Defect Count found the accept limits reject limits inspected.
(J N/A or C Other (specify)
Oo Oo Oo C
(] N/A or (] Other (specify)
Oo o oJ a
C] N/A or C Other (specify)
o o Oo O
CJ N/A or C Other (specify)
Oo Oo Oo 0
J N/A or C) Other (specify)
o oO Oo Md
CJ N/A or C Other (specify)
Oo Oo Oo E
(1 N/A or () Other (specify)
O O O =
Inspection Supporting Information (notes, comments, references)
CIN/A ( See Below
Inspection Actions (none or all actions that apply)
(CJ None OC Initiate Additional Product Inspection
C1 Initiate Re-work of product. Reference re-work protocol or describe in supporting information
C Reject product. Reference or provide details in supporting information
C Other — as described in supporting information
Name Title Signature Date
Completed By: