Critical Control Point Specifications

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1.0 Purpose 
 The purpose of this procedure is to establish critical control review point specifications for all
 products during manufacturing and packaging processes at Jon Labs, Inc. 
 2.0 Scope 
 This procedure applies to all manufacturing and packaging processes at Ion Labs, Inc.
 
 3.0 Responsibility 
 
 cm It is the responsibility of any employee performing PQC or PQV activities for any critical
 
 control point to strictly follow this procedure. 
 
 3.2 It is the responsibility of the Food Safety and Regulatory Supervisor to assess, identify,
 
 and document Food Safety CCPs in the hazard analysis of the HACCP-HARPC (Food
 Safety Plan). 
 
 4.0 Definitions 
 
 4.1 Critical Control Point (CCP) — a point at which controls are applied and adherence to
 specification is determined prior to proceeding with the manufacturing or packaging
 
 process 
 
 4.2 Food Safety CCP (FS-CCP) — a point in the process where an identified food safety
 
 hazard can be prevented, eliminated, or reduced to acceptable levels
 
 4.3 Critical Control Point 1 — Blending (CCP 1) — the point after the blending process of
 
 solid dosage powders 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 2 of 17 
 
 4.4 Critical Control Point 2— Compression & Encapsulation (CCP 2) — the initial startup
 approval for the Compression or Encapsulation process 
 
 4.5 Critical Control Point 3 — Packaging (CCP 3) — Dosage delivery for scoops (or
 
 equivalent) used for powder products 
 
 4.6 Critical Control Point 4 — Metal Detection (CCP 4) — metal detection for tablets,
 
 capsules, powders, and liquids 
 
 4.7 Critical Control Point 5 — Blister Packaging (CCP 5) — the initial startup approval for
 
 the blister packaging process 
 
 4.8 Critical Control Point 6 — Liquid Tank Sampling (CCP 6) — the point after the
 
 blending process of liquid form products 
 
 4.9 Critical Control Point 7 — Liquid Bottling Weight Verification (CCP 7) — the initial
 
 startup approval for the liquid bottling process 
 
 4.10 Critical Control Point 8 — Pouching (CCP 8) — the initial startup approval for the pouch
 
 packaging process 
 
 4.11 Critical Control Point 9 - Gummy Blend °Brix Record (CCP 9) - Gummy base
 cooking verification 
 
 4.12 Critical Control Point 10 — Deposition Checks (CCP 10) — Gummy flow calibration
 and weight verification 
 
 4.13 Critical Control Point 11 - Gummy Pre-Curing (CCP 11) — Organoleptic testing and
 pH 
 
 4.14 Critical Control Point 12 — Gummy Post-Curing (CCP 12) — Water activity and
 content testing 
 
 4.15 PQC — Process Quality Check 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | RevNo | Page 
 Critical Control Point Specifications C-707 16 3 of 17 
 
 4.16 PQV — Process Quality Verification 
 
 4.17 QC — Quality Control 
 
 4.18 MBR -— Master Batch Record 
 
 4.19 BPR — Batch Production Record 
 
 4.20 Brix (Bx) — The approximation of percent non-volatile content of a solution, based off
 the refractive index of a high sugar solution 
 
 4.21 R&D — Research and Development 
 
 5.0 References 
 
 5.1 C-707-F1, Form, CCP1 — Blending (Absence of Foreign Material and Bulk Density)
 
 Bae C-707-F2, Form, CCP2 — Compression Startup Check 
 
 3:3 C-707-F3, Form, CCP2 — Encapsulation Startup Check 
 
 5.4 C-707-F4, Form, CCP4 — Metal Detection (Manual) 
 
 5.5 C-707-F5, Form, CCP4 — Metal Detection (Inline) 
 
 5.6 C-707-F6, Form, CCP4 — Metal Detection (Insight Throat) 
 
 5.7 C-707-F7, Form, CCP3 — Dosage Delivery 
 
 5.8 C-707-F8, Form, CCP5 — Blister Packaging Startup Check 
 
 5.9 C-707-F9, Form, CCP6 — Liquid Tank Sampling 
 
 5.10 C-707-F10, Form, CCP7 — Liquid Weight Verification 
 
 5.11 C-707-F11, Form, CCP 8 — Pouch Packaging Startup Check 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 4 of 17 
 
 5.12. C-707-F12, Form, CCP 9 —- Gummy Blend Brix Record 
 
 5.13. C-707-F13, Form, CCP10 —- Gummy Blend Deposition Checks 
 
 5.14 C-707-F14, Form, CCP11 — Gummy Pre-Curing 
 
 5.15 C-707-F15, Form, CCP12 — Gummy Post-Curing 
 
 5.16 C-502, SOP, Record Storage, Retention, and Destruction 
 
 5.17 D-794, SOP, Use and Calibration of an Analog Brix Meter 
 
 5.18 D-201, SOP, QC Laboratory Sample Logbook Recording 
 
 5.19 B-603, SOP, Insight Throat Metal Detector 
 
 5.20 B-629, SOP, Inline Metal Detector 
 
 5.21 B-630, SOP, Manual Metal Detector 
 
 5.22 A-106, SOP, Documentation Guidelines for cGMP Records 
 
 5.23 B-905, SOP, Quality Inspection Process 
 
 5.24 Food Safety Plans (HACCP-HARPC) 
 
 6.0 Procedure 
 
 6.1 PQC and PQV 
 
 6.1.1 A PQC isa process quality check. PQV is a process quality verification. Refer to
 SOPs A-106 Documentation Guidelines for cGMP Records and B-905 Quality
 
 Inspection Process for details on the requirements for a PQC and PQV.
 
 6.2 Food Safety Plan (HACCP-HARPC) 
 
 6.2.1 AFS-CCP (Food Safety “FS” CCP) defines critical control preventative measures
 
 
 

[SOP 

 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 5 of 17 
 
 that a product conforms to prior to continuing the next process stage.
 
 6.2.2 FS-CCPs will be identified and documented in the Hazard Analysis only (for
 
 example: FS-CCP 4 Metal Detection). 
 
 6.2.3 FS-CCPs will be documented as CCP # on the Process Flow Diagram as
 
 referenced (for example CCP 4 Metal Detection). The Process Flow Diagram will
 
 include other process CCP’s referenced. 
 
 6.3 The process may not continue until the requirements of the CCP have been met and
 
 verified. 
 
 6.4 All samples must be collected in a manner to prevent contamination. This requires the
 
 use of clean gloves and clean sampling instruments to remove samples from the container
 or equipment. 
 
 6.5 CCP1-— Blending (Absence of Foreign Material and Bulk Density) 
 
 6.5.1 After the blending process, the following should be performed:
 
 6.5.1.1 A sieve test (sieve size 2.4mm or smaller) for absence of foreign
 material — collect approximately 20g samples from the top of the
 
 containers that represent (1) Beginning, (2) Middle, and (3) End of blend
 after transfer into holding containers. A visual inspection of the product
 
 on top of the container(s) will be conducted while a sieve test is
 
 performed. 
 
 Example: If there are five (5) containers, collect the sample from
 
 container 1, 3 and 5. 
 
 6.5.1.1.1 A blend with no foreign material will be approved.
 
 6.5.1.1.2 If foreign material is found, check “Fail” on the form and
 contact QC and/or R&D. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 6 of 17 
 
 6.5.1.2 Bulk Density Test — collect 100gm samples from container(s) that
 represent (1) Beginning, (2) Middle, and (3) End of blend after transfer
 
 into holding containers. 
 
 6.5.1.2.1 Tare a 100ml graduated cylinder and gently transfer, via a
 
 clean funnel, sufficient powder to fill 5Oml to 60ml of
 
 powder with minimum shaking or vibrations. 
 
 6.5.1.2.2 Weigh the net weight of the powder transferred into the 100
 
 ml graduated cylinder and record as weight. 
 
 6.5.1.2.3 Determine the volume by gently moving the graduated
 
 cylinder to create a flat surface for accurate line to determine
 measured volume using only whole numbers, and record as
 
 volume. 
 
 6.5.1.2.4 A blend will be approved if results meet the acceptance
 
 criteria. 
 
 6.5.1.2.5 If there are any problems, notify QC, R&D, and Production
 Management. 
 
 6.5.2 Document Performed By/Date (PQC) and Approved By/Date (PQV) on Form C-
 707-F1 CCP1 — Blending (Absence of Foreign Material and Bulk Density.
 
 6.5.3. Upon completion and approval of form C-707-F1 CCP1 — Blending (Absence of
 Foreign Material and Bulk Density, the blend will be released to the next
 
 manufacturing stage. 
 
 6.6 CCP 2 — Compression Startup Check 
 
 6.6.1 CCP for tablets consists of performing individual tablet checks for weight,
 thickness, hardness, and friability. 
 
 
 

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 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 7 of 17 
 
 6.6.2 Weigh 10 tablets individually, and determine the average weight. Each of the
 individual weights should be within the limits of 95% and 105% of the average
 
 weight (target weight). 
 
 6.6.3 Measure the thickness of 10 tablets individually and determine the average
 
 thickness. Each of the individual thickness results should be within the limits of
 
 90% - 110% of the average. 
 
 6.6.4 If all of the tablets do not fall within the range limits, the equipment must be
 
 adjusted to ensure that the tablets meet the current product specification. Tablets
 must be consistent in size, color, and shape. 
 
 6.6.5 Friability testing - For tablets with a unit weight equal to or less than 650 mg, take
 a sample of whole tablets corresponding as near as possible to 6.5 g. For tablets
 
 with a unit weight of more than 650 mg, take a sample of 10 whole tablets. The
 tablets should be carefully dedusted prior to testing. Accurately weigh the tablet
 
 sample (initial weight), and place the tablets in the drum. Rotate the drum 100
 
 times for non-chewable tablets and 50 times for chewable tablets, and remove the
 tablets. Remove any loose dust from the tablets and accurately weigh (final
 
 weight). Use the formula below: 
 
 Initial Weight (_ __)—Final Weight( )x100% = % 
 
 Initial Weight( +) 
 
 6.6.5.1 High limit is 1.0 % for non-chewable tablets. High limit for chewable
 
 tablets is 5.0%. 
 
 6.6.5.2 If there are any problems, notify QC, R&D, and/or Production
 
 Management. 
 
 6.6.6 Upon completion and approval of form C-707-F2 CCP2 — Compression Startup
 
 Check, the compression process may proceed. 
 
 
 

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 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 8 of 17 
 
 6.7 CCP 2-Encapsulation Startup Check 
 
 6.7.1 Weigh 10 intact capsules individually, and determine the average weight. Each of
 
 the individual weights should be within the limits of 95% and 105% of the
 average weight (target weight). 
 
 6.7.2 If all of the capsules do not fall within the range limits, notify the operator to
 make the necessary adjustments to the equipment to ensure that capsules meet the
 
 current product specification. 
 
 6.7.3. Capsules must be completely locked with consistent size, color, and powder
 quantity. 
 
 6.7.4. If the capsules meet the acceptance criteria, the operator may proceed with
 encapsulation startup. 
 
 6.7.4.1 If there is any problem, notify QC and/or R&D. 
 
 6.7.5 Upon completion and approval of form C-707-F3 CCP2 — Encapsulation Startup
 
 Check, the encapsulation process may proceed. 
 
 6.8 CCP 3-— Packaging (Dosage Delivery) 
 
 6.8.1 Some packages have components such as scoops, medicine droppers, and dosage
 cups, which indicate that a specific quantity of material is contained or dispensed
 
 therein. These components are to be checked prior to packaging the batch.
 
 6.8.2 In each case, the average weight delivery must fall within 90% - 110% of the
 
 label claim delivery (or as required by customer specifications).
 
 6.8.2.1 Direct Weighing (powders): 
 
 6.8.2.1.1 Dispense 10 dosage units into three tared containers and
 
 determine the average weight of the containers. The average
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev No 
 Page 
 Critical Control Point Specifications C-707 16 9 of 17 
 
 weight must be within the limits of 90% - 110% of the label
 claim delivery. 
 
 Example: Label claims each delivery contains 10.0gm 
 
 90% - 110% of 10.0gm (9.0gm - 11.0gm) 
 
 Dispense 10 dosage units into three tared containers
 
 Container 1 weight: 107.0gm 
 
 Container 2 weight: 104.0gm 
 
 Container 3 weight: 105.0gm 
 
 Average weight: (107.0 + 104.0 + 105.0)/ 3 = 105.3gm
 
 105.3gm/ 10 = 10.5gm 
 
 6.8.2.2 If there are any problems, notify QC, R&D, and/or Production
 
 Management. 
 
 6.8.3. Upon completion and approval of form C-707-F7 CCP3 — Dosage Delivery, the
 
 packaging process may proceed. 
 
 6.9 CCP 4-— Metal Detection (Tablets/Capsules/Powders/Liquids) 
 
 6.9.1 All tablets, capsules, powders, and liquids (unless otherwise noted) must pass
 through the metal detector without indication of containing metal.
 
 6.9.2 System Suitability - Manual Metal Detector 
 
 6.9.2.1 Using a calibration sample kit as outlined in SOP B-630 Manual Metal
 
 Detector, pass the test samples individually through the machine. The
 samples contain metal and should be rejected. 
 
 
 

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 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 10 of 17 
 
 6.9.2.2 Recover and remove each test sample after use. 
 
 6.9.2.2.1 If there are any problems, notify QC and/or Production
 
 Management. 
 
 6.9.2.3 Upon completion and approval of form C-707-F4 CCP4 — Metal Detection
 
 (Manual), the product may proceed with metal detection until completion.
 
 6.9.3 System Suitability — Inline Metal Detector 
 
 6.9.3.1 Using a calibration sample kit as outlined in SOP B-629 Inline Metal
 Detector, pass the test samples individually through the center of the
 
 machine. The samples contain metal and should be rejected into the
 
 rejection plate on the conveyor. 
 
 Note: The sample must be allowed to fully reject into the rejection plate in
 
 order to confirm machine accuracy. Do not grab the sample form the
 
 conveyor. 
 
 6.9.3.2 Recover and remove each test sample after use. 
 
 6.9.3.2.1 If there are any problems, notify QC and/or Production
 
 Management. 
 
 6.9.3.3. Upon completion and approval of form C-707-F5 CCP4 — Metal
 
 Detection (Inline), the product may continue through the packaging
 
 process. 
 
 6.9.4 System Suitability — Insight Throat Metal Detector 
 
 6.9.4.1 Using a calibration sample kit as outlined in SOP B-603 Insight Throat
 
 Metal Detector, enter from the bottom and insert each test piece
 
 individually into the black pipe and center the probe in the middle of the
 pipe. Solid bars indicate that metal has been detected and there will be a
 
 
 

[SOP 

 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 11 of 17 
 
 sound signal. 
 
 6.9.4.2 Recover and remove each test piece after use. 
 
 6.9.4.2.1 If there are any problems, notify QC and/or Production
 Management. 
 
 6.9.4.3 Upon completion and approval of form C-707-F6 CCP4 — Metal
 Detection (Insight Throat), the product may continue through the
 
 packaging process. 
 
 6.10 CCP 5-—Blister Packaging (Blister Packaging Startup Check) 
 
 6.10.1 Three (3) blister strips should be pulled from each blister drop. The following will
 
 be evaluated: 
 
 6.10.1.1 Blister Form and Seal - blister cavities are formed uniformly and the foil
 is sealed with the dots notably distinguished and even from each side of
 
 blister edge to cavity. 
 
 6.10.1.2 Blister Card Coding — ensure that the blister card has correct and legible
 
 coding, as required by the product’s packaging profile. 
 
 6.10.1.3 Product Quality — verify blister count (all cavities are filled) and make
 
 sure that product in the blister is free from chips, breaks, and foreign
 
 material. 
 
 6.10.1.4 Push/Tear Test — push product through the foil and ensure that the
 
 component is dispensed easily and not damaged. 
 
 6.10.1.5 Blister Submersion Leak Test — wear gloves and perform a leak test by
 
 submersing three blister cards (one from each drop) into colored water
 
 
 

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 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 12 of 17 
 
 for minimum of one minute, then inspect for seal integrity by drying off
 the blister card and inspecting the blister seal for blue water penetration
 
 into the blister cavity and around the edge of the blister seal.
 
 6.10.1.5.1 If there are any problems, notify QC and/or Production
 
 Management. 
 
 6.10.1.6 Upon completion and approval of form C-707-F6 CCP4 — Metal
 
 Detection (Insight Throat), the product may continue through the
 
 packaging process. 
 
 6.11 CCP 6 - Liquid Tank Sampling 
 
 6.11.1 Upon completion of mixing the liquid batch, a Mix Tank Laboratory Sample will
 be taken from the top of the tank and from the bottom of the tank.
 
 6.11.2 Using a clean sterile 100ml green cap cup, for the C-707-F8 “Bulk” Liquid Tank
 Sample collection, collect approximately 100ml of product from the top and
 
 100ml from the bottom of the mixing tank. Cover the container with the green cap
 
 and tighten. 
 
 6.11.3 Identify the mix tank samples with the following information:
 
 6.11.3.1 Product Name 
 
 6.11.3.2 Batch Number 
 
 6.11.3.3 Circle if sample is from the top or bottom of the mixing tank
 
 6.11.3.4 Initials and Date of collecting employee 
 
 6.11.4 Forward the Mix Tank Sample to the QC laboratory and document the sample as
 
 per SOP D-201 QC Laboratory Sample Logbook Recording. Indicate that the
 sample is from CCP-6 Bulk Liquid Mix Tank (top or bottom). 
 
 6.11.5 Reference Form C-707-F9 CCP-6 Liquid Tank Sampling for documenting visual
 
 and QC Laboratory test results. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 13 of 17 
 
 6.11.6 Once the laboratory sample is completed by the QC Laboratory and is acceptable,
 the blend will be released to be transferred to the liquid filler and/or holding tank.
 
 6.12 CCP 7- Liquid Weight Verification 
 
 6.12.1 CCP 7 defines Critical Control Point to determine that the product volume weight,
 
 in grams, conforms to specifications for meeting label claim. 
 
 6.12.2 Target weight is based on the theoretical formulated dose weight of loz applying
 
 the established product density. 
 
 6.13 Determining the Average Fill Bottle Weight 
 
 6.13.1 Set the fill volume to target weight. Once the machine is set, fill ten consecutive
 
 bottles without cap or seal and check the weight of each bottle, Document the
 weights on Form C-707-F10 in the “Weight” section. 
 
 6.13.2 Add the ten bottle weights and divide by ten to determine the average fill weight.
 If volume is below desired product weight, adjust fill volume and reweigh ten
 
 more bottles and document. 
 
 6.13.3 If the fill weight is within specification, circle, “Pass”. If bottle weights cannot be
 
 achieved, circle “Fail” and inform a Production supervisor and QC.
 
 6.13.4 If there are any comments, document them in the comments section.
 
 6.13.5 Document Performed By/Date (PQC) and Approved By/Date (PQV) on Form C-
 
 707-F 10. 
 
 6.13.6 Packaging of the product may begin once form C-707-F10 has been approved.
 
 6.14 CCP 8 — Pouching Startup 
 
 6.14.1 Pouch Seal - A visual check will be made that the pouch is sealed on both sides
 
 with a notch cut into one side. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 14 of 17 
 
 6.14.2 Pouch Coding - ensure that the pouch has the correct coding as specified in the
 product’s packaging profile. 
 
 6.14.3 Product Quality - verify pouch count (if applicable) and ensure that product in
 the pouch is correct and free from chips, breaks, and foreign material.
 
 6.15 CCP 9-—Gummy Blend Brix Record 
 
 6.15.1 Obtain a small sample of the blend with a clean utensil and deposit it on the prism
 
 of a clean Brix meter. 
 
 6.15.2 Close the Brix meter cover and press firmly to get a thin layer of the blend over
 
 the prism. 
 
 6.15.3 Look through the eyepiece of the brix meter in a well-lit area, ensuring to hold the
 Brix meter level. 
 
 6.15.4 Record the reading where the blue and white areas meet. 
 
 6.15.5 This measurement must be repeated in reproducible duplicates.
 
 Note 1: Reference SOP D-794 Use of an Analog Brix Meter for more details regarding
 the use and calibration of an analog brix meter. 
 
 Note 2: The measurement is dependent on temperature. As the product cools the °Bx will
 increase. Allow the mixture to cool enough so that the °Bx is constant and use
 
 that as the recorded value. 
 
 6.16 CCP 10-—Gummy Start Up 
 
 6.16.1 The desired flow rates in kilograms or grams per minute is indicated in the batch
 
 record. 
 
 6.16.2 Perform flow calibration of the liquid dosing pumps via weigh by difference
 
 method as described on form C-707-F13 Deposition Checks. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 15 of 17 
 
 6.16.3 Perform flow calibration of the batter dosing pump via direct weight method as
 described on form C-707-F13 Deposition Checks. 
 
 6.16.4 Adjust the flow rate and repeat calibration as necessary in order to reach the
 desired flow rate. Record flow rates and settings used in the BPR.
 
 6.16.5 Obtain the desired deposit weight range from the product profile in the BPR.
 
 6.16.6 Deposit at least 5 rows of gummies and then stop depositing. The first rows will
 
 be under filled while the system primes. 
 
 6.16.7 Weigh one gummy from each well of a single mold individually and determine
 the average weight. Each of the individual weights should be within the limits
 
 90% - 110% of the average weight. 
 
 6.16.8 If there is high variance in the gummy weight, adjust the depositors individually
 
 and repeat step 6.16.7. If the gummies are uniformly too high or too low, adjust
 the deposit length using the computer interface of the machine and repeat step
 
 6.16.7. 
 
 6.16.9 Inspect the organoleptic properties of the gummies for consistency in size, color,
 
 smell, and general appearance. 
 
 6.16.10Inspect the gummies for foreign material. 
 
 6.16.11Record all results on form C-707-F13 Deposition Checks, located in the BPR.
 
 6.17 CCP 11— Gummy Pre-Curing 
 
 6.17.1 Upon startup and approximately every hour while running, bring 3 gummies to
 
 the QC laboratory for organoleptic and pH testing. 
 
 6.17.2 The gummies must be labeled with the date they were made, the batch number,
 
 and the time they were sampled. They must be accompanied by form C-707-F14
 
 
 

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 Standard Operating Procedure SOP No | RevNo | page 
 Critical Control Point Specifications C-707 16 16 of 17 
 
 Pre-Curing, located in the BPR. 
 
 6.17.3 The results will be compiled by the QC Laboratory and retrieved by Production
 
 personnel before the batch is released for packaging operations.
 
 6.18 CCP12— Gummy Post-Curing 
 
 6.18.1 After approximately 24 hours of drying and approximately every 12 hours after, a
 gummy sample will be delivered to the QC Laboratory for water activity and
 
 water content testing. 
 
 6.18.2 The gummies are grouped according to the day in which they were manufactured.
 At least 5 gummies per day of running are necessary for the tests.
 
 6.18.3 The gummies must be labeled with batch number, the sub-batches ran on that day,
 the time they were placed in the drying room, and the time they were removed
 
 from the drying room for analysis. They must be accompanied by form C-707-
 F15 Post-Curing, located in the BPR. 
 
 6.18.4 The results will be compiled by the QC Laboratory and retrieved by Production
 
 personnel before the batch released for packaging operations. 
 
 6.19 Manufacturing of batches may not proceed without meeting the acceptance criteria of the
 
 CCPs or adequate justification for not meeting criteria. 
 
 6.20 Documentation Maintenance 
 
 6.20.1 CCP forms will be included as a part of each MBR as required by the product
 form and issued with each BPR. Records will be maintained following SOP C-
 
 502 Record Storage, Retention, and Destruction. 
 
 
 

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 Standard Operating Procedure SOP No | RevNo | Page 
 Critical Control Point Specifications C-707 16 17 of 17 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 08/06/10 | New = - l 12/12/10 Added CCP2 for Tablets and Capsules - - | - | - |
| 2 | 03/22/11 | Added CCP3 for Packaging - - | - | - |
| 3 | 04/26/11 | Made some minor changes - - | - | - |
| 4 | 08/08/11 | Changes in the forms - - | - | - |
| 5 | 10/18/11 | Added CCP4 for Metal Detection - - | - | - |
| 6 | 06/21/12 | Made SOP and Forms more detailed - - | - | - |
| 7 | 05/31/13 | Changed the logo, added bulk density test in CCP1, organized and . clarified the SOP and forms - | - | - |
| 8 | 08/26/13 | a on the forms, removed 5.8.5, changed % limits to whole | 13-728 | V. Iltcheva |

 Revised entire procedure, added record for blister packaging, 
 9 02/11/14 removed C-707-F2A 14-0142 V. Iltcheva 
 10 04/09/14 | Added 4.7, 5.7, 5.10 14-0309 V. Iltcheva 
 11 09/22/14 | Corrected some format issues. 14-0748 K. Burris 
 12 05/11/15 | Added CCP 7 & CCP 8 for liquids with detailed information. 15-0203 M. Wienke
 1B 06/15/16 Updated ccP 8 for liquids to reflect product specific weight 16-0600 L. Titolo
 specification 
 Complete rewrite to reflect new ERP requirements. Obsolete 
 14 09/10/18 | processes removed. All forms revised and renumbered per ERP 18-0302 K. Burris
 System. Added new forms. 
 Added critical control point testing for gummy process. Added Ais ‘
 a ChiOsiat information on food safety and quality critical control points. ssialinialinad Be Wilson
 16 03/13/23 Procedure rewrite to remove QC from requirements and replace CC-23-0133 ©. Burs
 with PQV requirements. 
 
 
 

[SOP 

 Page 1 of 1
 . Batch Record 
 V‘ QP|O \KK CCP 1 — Blending (Absence of Foreign Material and Bulk Density) 
 — Form: — C-707-F1 CCR No. CC-23-0133 Revision: 1 
 
 1. Absence of Foreign Material Sieve ID: 
 
 Instructions: Collect approximately 20g samples from the top drums that represent (1) Beginning, (2) Middle and (3) End of blend after transfer into holding containers. A visual
 inspection of the product on top of the drum(s) will be conducted while a sieve test is performed.
 Acceptance Criteria: Foreign Particulate Fail Pass 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 2. Blend Uniformity Balance ID # Calibration Due Date 
 
 Instructions: Collect approximately 100gm samples from_drum(s) that represent (1) Beginning, (2) Middle and (3) End of blend after transfer into holding containers.
 Method: 1. Tare a 100 ml graduate cylinder and gently transfer via a funnel sufficient powder to fill 50 ml to 60 ml of powder with minimum shaking or vibrations.
 2. Weigh the net weight of powder transferred into 100 ml graduated cylinder, record as weight (a).
 3. Determine volume by gently moving graduated cylinder to create a flat surface for accurate line to determine measured volume using only whole numbers, record as
 volume (b). 
 Calculations: Percent of Average = Individual Density Value/ Average Density Value x 100 Acceptance Criteria: All samples 95% to 105% of Average Value
 Results: Loose Bulk Density 
 Sample a. Weight (gm) b. Volume (ml) Density (a/b) Percent of Average 
 1. Beginning 
 2. Middle 
 3. End 
 Average 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 

[SOP 

 Page 1 of 1
 Batch Record 
 CCP 2 — Compression Startup Check 
 Form: C-707-F2 CCR No. CC-23-0133 Revision: 1 
 
 Hardness Tester Balance 
 
 Thickness Gauge Friabulator 
 Tablet Testing: Weigh 10 tablets individually, and determines the average weight. Each of the individual weights should be within the limits of 95% - 105% of the average weight.
 Measure the thickness on 10 tablets individually and determine the average thickness. Each of the individual thickness should be within the limits of 90% - 110% of the
 average thickness. Tablets must be consistent (size, color, shape). 
 Friability: For tablets with a unit weight equal to or less than 650 mg, take a sample of whole tablets corresponding as near as possible to 6.5gm. For tablets with a unit weight of
 more than 650mg, take a sample of 10 whole tablets. The tablets should be carefully dedusted prior to testing. Accurately weigh the tablet sample (initial weight), and
 place the tablets in the drum. Rotate the drum 100 times for non-chewable tablets and 50 times for chewable tablets, and remove the tablets. Remove any loose dust from
 the tablets, and accurately weigh (final weight) 
 1 
 2 
 3 Acceptance Criteria: High limit is 1.0% for non-chewable tablets.
 4 High limit for chewable tablets is 5.0%.
 5 
 6 
 7 
 8 wa: . . . 
 9 Initial Weight ( ) — Final Weight ( ) x 100% = %
 10 Initial Weight ( _) 
 Average 
 Low Limit 
 Average - 10% Average - 5% kp 
 High Limit 
 Average + 10% Average + 5% kp 
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 

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 Batch Record 
 CCP 2 - Encapsulation Startup Check 
 Form: C-707-F3 CCR No. CC-23-0133 Revision: 1 
 
 1. Individual Capsule Testing Balance ID # Calibration Due Date 
 
 Instructions: Weigh 10 intact capsules individually, and determine the average weight. Each of the individual weights should be within the limits 95% - 105% of the average weight.
 Capsules must be completely locked with consistent size, color, and powder quantity. 
 
 Capsules completely locked with consistent size, color and powder quantity Yes No 
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 

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 Batch Record 
 CCP 4 —- Metal Detection (Manual) 
 Form: C-707-F4 CCR No. CC-23-0133 Revision: 1 
 
 MANUAL METAL DETECTOR Equipment ID # 
 
 Verify cleaning log book for room/ equipment is completed. 
 Check the operation of the machine by passing the required test samples through the machine (Good/Bad). Do NOT proceed if a test sample containing
 metal is not rejected, notify maintenance for repairs. Proceed if test sample is rejected. Test samples not containing metal should not be rejected.
 Recover and remove test samples. 
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 Place a clean catch container under both the passing chute and reject chute. 
 Add product to the hopper feeding metal detector. 
 Continue until the entire batch is processed. 
 
 Note: Collect and record any rejected product to packaging waste 
 
 Acceptance Criteria: All tablets and capsules for packaging must pass through the metal detector without triggering the reject mechanism.
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 

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 Batch Record 
 CCP 4 — Metal Detection (Inline) 
 Form: C-707-F5 CCR No. CC-23-0133 Revision: 1 
 
 INLINE METAL DETECTOR Equipment ID # 
 
 Verify cleaning log book for room/ equipment are complete. 
 
 With the display of the machine showing a bar graph with empty rectangles (no metal detected) the machine is ready to test.
 Pass a test sample through the center of the machine. The sample do not contain metal and should not activate the machine, bar graph will show empty
 rectangles (no metal detected). 
 Pass a test sample through the center of the machine. The sample contains metal and should activate the machine to alert that metal is present, bar graph will
 show filled rectangles when metal is present. The sample should be discarded to the rejection plate on the conveyor.
 Recover and remove the samples. 
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 Start packaging and continue until the entire batch is processed. 
 
 Note: Collect and record any rejected product to packaging waste 
 
 Acceptance Criteria: All product for packaging must pass through the metal detector without triggering the reject mechanism.
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 

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 Batch Record 
 CCP 4 - Metal Detection (Insight Throat) 
 Form: C-707-F6 CCR No. CC-23-0133 Revision: 2 
 
 INSIGHT THROAT METAL DETECTOR — Equipment ID # 
 
 Verify cleaning log books for room/ equipment are complete. 
 With the display of the machine showing a hollow bars (no metal detected) the machine is ready to test. 
 Insert the metal test probe into the black pipe and center the probe in the middle of the pipe. Solid bars indicate that metal has been detected and there will be a
 sound signal. 
 
 Remove the metal test probe. 
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 Start filling process and continue until the entire batch is processed. 
 Note: Collect and record any rejected product to packaging waste 
 
 Acceptance Criteria: All powder for packaging must pass through the metal detector without triggering the reject mechanism.
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 

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 Batch Record 
 CCP 3 — Dosage Delivery 
 Form: C-707-F7 CCR No. CC-23-0133 Revision: 2 
 
 1. Dosage Delivery Verification 
 
 Label Claims each delivery contains Scale ID: 
 High Limit (label claims delivery + 10%) Calibration Due: 
 
 Low Limit (label claims delivery — 10%) 
 
 Direct Weighing 
 Dispense 10 dosage units (scoops) into 3 tared containers 
 
 Average for 10 dosage units 
 Average/10 (for 1 dosage unit) 
 
 Acceptance Criteria: Average weight is 90% - 110% of label claim delivery 
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 

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 Batch Record 
 CCP 5 — Blister Packaging (Startup Check) 
 Form: C-707-F8 CCR No. CC-23-0133 Revision: 1 
 
 1. Individual Blister Testing 
 Instructions: Pull 3 Blister strips, one from each drop for performing test 1- 4 and 3 additional Blister strips for performing test 5
 Note: While standing at the end of the blister drop section of the machine, drop one will start from the left side drop, drop two will be the center drop, drop three will be the right side
 drop. The following tests will be performed on each drop 
 1. Blister Form and Seal- A visual check will be made that the blister cavities are formed uniformly and the foil is sealed with the dots notably distinguished and even from each side
 of blister edge to cavity. 
 Batch # / Exp. or Best by Date - ensure the Blister Pack has the correct and readable Batch #/ Exp. or Best by Date.
 Product Quality — verify Blister count (all cavities are filled) and make sure that product in the blister is free from chips, breaks, and foreign material.
 Push/Tear test, push tablets/ capsules through the foil and ensure the component is dispensed easily and not damaged.
 . Blister Submersion Leak Test 
 Note: The blue dye solution utilized for the leak test is 30 mls of Methylene Blue Solution to 4 liters of water. Wear latex gloves and perform leak test by submersing 3 blister strips
 (one from each drop) into colored water for minimum of one minute; inspect for seal integrity by drying off the blister strip and inspecting the blister seal for blue water
 penetration into the blister cavity and around the edge of the blister seal. Discard blister strips and latex gloves and document it in the Batch Record.
 ww 
 Circle one P — pass; or F — fail 
 
 2 P / F P / F P / F P / F P / F 
 
 3 P / F P / F P / F P / F P / F 
 
 Determination - All parameters were met: (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 

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 Batch Record 
 CCP 6 — Liquid Tank Sampling 
 Form: C-707-F9 CCR No. CC-23-0133 Revision: 1 
 
 1. Visual inspection of blended product for Foreign Particulate Circle one: TOP of Tank / BOTTOM of Tank 
 
 Instructions: Collect two tank lab test samples, one from the top and one from the bottom of the tank. Label the container with CCP 6 — Liquid Tank Sample.
 
 Acceptance Criteria: If foreign material found check Fail and contact QC/R&D. If no foreign material found check Pass. _ Foreign Particulate Fail Pass
 
 2. QC Laboratory Organoleptic, pH, Density, Viscosity 
 Instructions: Perform the following test and indicate Pass or Fail and the specific value following the test results where indicated.
 
 Test Specification Result Pass / Fail By/Date 
 Organoleptic - Odor 
 Organoleptic - Color 
 Organoleptic - Appearance/Clarity 
 pH 
 Density 
 Viscosity 
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC — QC Laboratory)/Date: Approved By (PQV — QC Laboratory)/Date: 
 
 

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 Batch Record 
 CCP 7 — Liquid Weight Verification 
 Form: C-707-F10 CCR No. CC-23-0133 Revision: 1 
 
 1. Weight Verification Balance ID # Calibration Due Date 
 
 Instructions: Press Clear button on scale to zero out scale. Set fill Volume and weigh check the first filling increment of 10 containers to ensure proper fill volumes are maintained.
 Then take 10 consecutive filled containers, without cap or seal, and record below in the Weight section. Add the 10 volume weights and divide by 10 to reach an
 average weight. (Note: average weight of bottles has been predetermined) 
 
 Min Product Weight (g) Target Weight (g) Max Product Weight (g) 
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 

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 Batch Record 
 CCP 8 — Pouching (Startup Check) 
 Form: C-707-F11 CCR No. CC-23-0133 Revision: 2 
 
 Instructions: Pull 4 pouches (1 pouch from each drop) and perform the following tests: 
 
 1. Batch #/ Expiration Date - ensure the pouch has the correct and readable Batch #/ Expiration Date. 
 2. Product Quality — verify pouch count/fill and make sure that product in the pouch is correct, free from chips, breaks, and/or foreign material.
 3. Pouch Seal - Submersion Leak Test 
 Note: The blue dye solution utilized for the leak test is 30 mls of Methylene Blue Solution to 4 liters of water. Wear latex gloves and perform leak test by submersing each pouch
 into colored water for minimum of one minute; inspect for seal integrity by drying off the pouch and inspecting for blue water penetration on the inside of the pouch.
 Discard pouches and latex gloves and document results in the Batch Record. 
 
 Circle one P — pass; or F — fail 
 
 1 P / F P / F P / F 
 2 P / F P / F P / F 
 3 P / F P / F P / F 
 4 P / F P / F P / F 
 
 Determination - All parameters were met: (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 

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 Batch Record 
 CCP 9 — Gummy Blend Brix Record 
 Form: C-707-F12 CCR No. CC-23-0133 Revision: 1 
 
 1. Record °Brix for Each Sub-Blend in Kettles 1 & 2 
 
 Before moving the gummy blend from the kettles to tank 3, test the °Brix to ensure the blend meets the required specification. Obtain a small sample of the blend with a clean utensil
 and deposit it on the prism of a clean Brix meter. Close cover and press firmly to get a thin layer of the blend over the prism. Look through the eyepiece of the brix meter in a well-lit
 area, preferably with an incandescent light. Ensure to hold the brix meter level. Record the reading where the blue and white areas meet. This measurement must be repeated in
 reproducible duplicates. If °Brix is too low, continue heating the blend, re-testing periodically. If the °Brix is too high, immediately turn off the heat and pump to tank 3. Then contact
 R&D. R&D may calculate water to be added to bring the Brix back into an acceptable range. 
 
 Note: The measurement is dependent on temperature. As the product cools the °Bx will increase. Allow the mixture to cool enough so that the °Bx is constant and use that as the
 recorded value 
 "Brix | | | | | | | | | 
 Date 
 Time 
 Initials 
 
 Time 
 Initials 
 
 PQV: 
 
 

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 Batch Record 
 CCP 9 — Gummy Blend Brix Record 
 Form: C-707-F12 CCR No. CC-23-0133 Revision: 1 
 
 2. Record °Brix for Each Sub-Blend Mix in Tank 4 
 
 Periodically test the °Brix to ensure the blend meets the required specification. Obtain a small sample of the blend with a clean utensil and deposit it on the prism of a clean Brix
 meter. Look through the eyepiece of the brix meter in a well-lit area, preferably with an incandescent light. Ensure to hold the brix meter level. Record the reading where the blue and
 white areas meet. This measurement must be repeated in reproducible duplicates. If °Brix is out of specification, contact R&D. R&D may provide additional heat to raise the °Brix, or
 additional water to lower the °Brix. 
 
 Note: The measurement is dependent on temperature. As the product cools the °Bx will increase. Allow the mixture to cool enough so that the °Bx is constant and use that as the
 recorded value. 
 Brix | | | | | | | | | 
 
 Date 
 Time 
 Initials 
 
 “Brix 
 Date 
 Time 
 Initials 
 
 PQV: 
 
 

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 eo sbib 
 Batch Record 
 CCP 10 — Gummy Deposition Checks 
 Form: C-707-F13 CCR No. CC-23-0133 Revision: 1 
 
 Flow Calibration 
 
 Instructions: Ensure the flow of each subcomponent is calibrated according to table 1 according to the following procedure.
 
 Liquid Dosing Pumps (weigh by difference): 
 Fill a vessel with purified water and submerge the sink filter of the applicable dosing pump into the water. Determine the appropriate flow setting by comparing the
 required flow rate designated in the Mix Instructions with the example flow settings in Table 1. Turn on the applicable pump and set it to the applicable flow setting.
 Open the release knob on the back of the pump and then slowly close it ensure proper flow. Allow the pump to flow enough so that the lines are full of liquid. Obtain
 a suitable vessel for the subcomponent. Fill the vessel with the subcomponent and tare the vessel (record the tare weight in case the scale is accidentally reset).
 Remove the sink filter from the water and place it into the vessel containing the applicable subcomponent. Obtain a stopwatch and have it on standby. Simultaneously
 start the stopwatch and dosing pump. Stop the dosing pump after a minimum of 2 minutes. Remove the sink filter from the vessel and do your best to allow the
 material that clings to the outside of the sink filter to drip back into the vessel. Weigh the vessel and determine the amount of material that was pumped by taking
 the difference of the initial weight and the weight after pumping. Determine the flow rate by dividing the amount of material pumped by the time spent pumping.
 Remember that 60 secs = 1 min, e.g. a time of 1:15 = 1.25 minutes. Compare the measured flow rate to the required flow rate listed in Table 1 and adjust the setting
 on the pump as necessary. Repeat this procedure until the measured flow rate is correct. 
 Batter Dosing Pump (weigh directly): 
 Obtain a suitable vessel for the batter and tare it (record the tare weight in case the scale is accidentally reset). Obtain a stop watch and have it on standby. Obtain a
 secondary container to catch material that is not being weighed, to limit wasted batter. Place a floor pan under the output to aid in clean up. Determine the appropriate
 flow setting by comparing the required flow rate designated in the Mix Instructions with the example flow settings in Table 1. Turn on the pump and set it to the
 applicable flow setting. Allow the pump to discharge the water in the lines onto the floor pan, and wait until there is a steady flow of batter. Immediately switch
 flow to the tared vessel and simultaneously start the stop watch. Collect material for a minimum of 2 minutes, then switch flow from the tared vessel to the secondary
 container. Weigh the tared vessel to determine the amount that was pumped. Determine the flow rate by dividing the amount of material pumped by the time spent
 pumping. Remember that 60 secs = 1 min, e.g. a time of 1:15 = 1.25 minutes. Compare the measured flow rate to the required flow rate as designated in the Mix
 Instructions and adjust the setting on the pump as necessary. Repeat this procedure until the measured flow rate is correct. The material in the secondary container
 and the tared vessel is to be added back into Tank 4. 
 
 

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 Batch Record 
 CCP 10 — Gummy Deposition Checks 
 
 Form: C-707-F13 CCR No. CC-23-0133 Revision: 1 
 
 Table 1: Example Flow Settings 
 
 Table 2: Measured Flow Settings 
 
 

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 Batch Record 
 CCP 10 — Gummy Deposition Checks 
 
 Form: C-707-F13 CCR No. CC-23-0133 Revision: 1 
 
 2. Individual Gummy Weight Check Balance ID # Calibration Due Date 
 
 Instructions: Weigh one gummy from each well of a single mold individually and determine the average weight. Each of the individual weights should be within the limits 90%
 - 110% of the average weight. Gummies must be consistent in size, color, and general appearance.
 
 3. Organoleptic Inspection of Pre-Cured Gummies 
 
 Instructions: Collect five (5) gummies into one sample container, pre-cure gummies should be collected in the middle of the sub-batch.
 
 Gummies consistent in size, color, smell and general appearance? Yes No 
 Gummies absent of foreign particulate matter? Yes No 
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC)/Date: Approved By (PQV)/Date: 
 
 

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 Batch Record 
 =S SSSSs8 CCP 11 - Pre-Curing 
 
 he Form: C-707-F14 CCR No. CC-23-0133 Revision: 1 
 
 1. QC Laboratory Organoleptic / pH 
 
 Instructions: QC Laboratory will perform the following tests and indicate Pass or Fail and the specific value following the test results where indicated. These samples will be tested
 once every hour while running. 
 
 Test Specification Result Pass / Fail 
 Organoleptic - Odor 
 Organoleptic - Color 
 Organoleptic - Appearance/Shape 
 pH 
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC — QC Laboratory)/Date: Approved By (PQV — QC Laboratory)/Date: 
 
 

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 Batch Record 
 =S SSSSs8 CCP 12 - Post-Curing 
 
 ib Form: C-707-F15 CCR No. CC-23-0133 Revision: 1 
 
 1. QC Laboratory Water Activity 
 
 Instructions: QC Laboratory will perform the following test and indicate Pass or Fail and the specific value following the test results where indicated. Samples will be tested
 after the first 24 hours, and then approximately every 12 hours until the specified parameters are met.
 
 Test Specification Result 
 
 Water Activity <0.75 Aw 
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC — QC Laboratory)/Date: Approved By (PQV — QC Laboratory)/Date: 
 
 

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 Page 1 of 1 
 Batch Record 
 =S SSSSs8 CCP 12 - Post-Curing 
 
 ib Form: C-707-F15 CCR No. CC-23-0133 Revision: 1 
 
 1. QC Laboratory Water Activity 
 
 Instructions: QC Laboratory will perform the following test and indicate Pass or Fail and the specific value following the test results where indicated. Samples will be tested
 after the first 24 hours, and then approximately every 12 hours until the specified parameters are met.
 
 Test Specification Result 
 
 Water Activity <0.75 Aw 
 
 Determination (circle one) Pass Fail 
 
 Performed By (PQC — QC Laboratory)/Date: Approved By (PQV — QC Laboratory)/Date: