Master Manufacturing Record – Pre-Weigh Module

SECTION 1: Reference Documents

Enter the Primary Jira Work Item. Product and batch information will automatically populate from the Jira record and cannot be edited within this document.

This section identifies the governing documents and system records used during execution of the Pre-Weigh stage. Product requirements, formulation details, and batch execution instructions are maintained within their respective systems of record, including the Product Specification, Approved Formula, and ERP-generated Pre-Weigh Batch Record. This Master Manufacturing Record defines the approved manufacturing procedure. Authoritative product and batch data must be obtained from the controlled source documents referenced in this section.

1.2 Core Document Sources

The following controlled documents and system records provide the authoritative product and batch information required for execution of this procedure.

1.3 Pre-Weigh Readiness

The following information is automatically populated from the Jira order and provides the operational context for the manufacturing batch.

Pre-Weigh operations may begin only when the Approved Manufacturing Formula is in Approved status and this Master Manufacturing Record (MMR) has been reviewed and approved by Quality Assurance within the Quality Management System.

1.4 QU GATE

Quality Unit authorization confirms that all required core documents are present and the Manufacturing Formula is in Approved status before Pre-Weigh operations may begin.

1.5 QC Requirements Applicable to Pre-Weigh

Identifies the Quality Control requirements governing environmental conditions, instrument verification, and material acceptance criteria applicable to this manufacturing stage.

Component Specifications Specifications for each raw material component used in manufacturing, including identity, purity, strength, composition, and contaminant limits, are defined in the Raw Material Specifications maintained within the Quality Management System. Only materials that meet the approved component specifications and have been released by the Quality Unit may be used during the Pre-Weigh stage.

1.6 Batch Production Record Execution

Execution of the Pre-Weigh operation must be documented in the Pre-Weigh Batch Production Record generated for the specific manufacturing Work Order. The Batch Production Record defines the component quantities, lot numbers, and dispensing records required for execution of this procedure. Operators must follow the instructions contained in this Master Manufacturing Record together with the quantities and component details defined in the Pre-Weigh Batch Production Record. All actual weights, lot numbers, operator identifications, and verification signatures must be recorded in the Batch Production Record at the time the activity is performed.

SECTION 2: Facility Environmental Requirements

Environmental conditions during the Pre-Weigh stage must comply with the facility environmental monitoring requirements defined in QC-ENV-002 – Production Environmental Conditions. The environmental operating limits listed below are controlled by the Quality Management System and represent the validated operating limits for the manufacturing area. These limits are not defined by this Master Manufacturing Record and must not be modified within this document. Product-specific manufacturing instructions may define narrower operating ranges within these limits. Such requirements must be documented in the Process Control Parameters section. Under no circumstances may environmental conditions exceed the facility limits defined in QC-ENV-002.

SECTION 3: Process Control Parameters

The following process parameters represent the standard operating conditions for the Pre-Weigh stage. If the Product Specification defines different requirements for a specific product, the Product Specification Override column must be used to document the approved requirement.

SECTION 4: Equipment Requirements

The following equipment is required for execution of the Pre-Weigh stage.

Equipment must be suitable for use, clean where applicable, and within required calibration or verification status prior to pre-weigh.

Equipment setup and readiness verification must be completed in accordance with SOP-PROD-PREOP – Pre-Operation Readiness & Line Clearance prior to performing any scale verification or weighing activity.

Specific verification criteria are defined in the applicable Quality Control requirements referenced in Section 1.5.

Equipment identification and verification results are recorded in the Batch Production Record (BPR) or in the controlled execution record associated with this manufacturing batch.

4.1 Required Equipment and Utensils

The following equipment and utensils are approved for use in the Pre-Weigh stage when suitable for the intended operation.

4.2 Equipment Identification Record

Record the actual equipment assets used during execution of this Pre-Weigh operation. Asset identification must correspond to the equipment used for the manufacturing batch.

If additional equipment is used, add the information in accordance with approved documentation practices before finalization of the record.

Equipment that is damaged, visibly contaminated, or outside calibration / verification status must not be used. Notify Quality and follow deviation procedures if required.

SECTION 5: Line Clearance

5.1 Line Start Authorization

Prior to initiation of manufacturing activities, a qualified individual must perform a Line Start verification confirming that the manufacturing area, equipment readiness, environmental conditions, and required documentation are acceptable for execution of the Pre-Weigh operation.

Line Start verification confirms that the manufacturing environment complies with the requirements defined in this Master Manufacturing Record (MMR) and that the production area is suitable for the current manufacturing batch.

Line Start authorization is documented within the approved electronic quality system (Jira). Manufacturing activities may begin only after Line Start verification has been completed and authorization has been granted.

Evidence of Line Start authorization is maintained within the electronic system and referenced within the associated Batch Production Record (BPR).

5.2 Pre-Weigh Line Clearance Procedure

Prior to beginning the Pre-Weigh operation, the Pre-Weigh area must be verified as clear of materials, components, equipment, labels, documentation, and waste associated with previous manufacturing operations.

Line clearance ensures that only materials and equipment required for the current manufacturing batch are present in the Pre-Weigh area and prevents cross-batch mix-ups, contamination, and documentation errors.

Completion of line clearance must be documented in the Batch Production Record (BPR) prior to initiation of Pre-Weigh activities.

Standard Procedure

1. 5.2.1 Verify that the Pre-Weigh area is free of materials, components, documentation, labels, and equipment associated with previous manufacturing operations.
2. 5.2.2 Remove all unrelated materials, containers, labels, documentation, and waste from the Pre-Weigh area.
3. 5.2.3 Verify that Pre-Weigh containers, liners, and utensils intended for use are empty, clean, and suitable for material contact.
4. 5.2.4 Confirm that all equipment required for the Pre-Weigh operation is present, properly identified, clean where applicable, and within required calibration or verification status.
5. 5.2.5 Verify that only materials required for the current batch and identified in the approved Pre-Weigh Batch Record are present in the Pre-Weigh area.
6. 5.2.6 Record completion of line clearance in the Batch Production Record prior to initiation of Pre-Weigh activities.
7. 5.2.7 Where required by the Batch Production Record or Quality procedures, a second qualified individual must verify completion of line clearance prior to beginning the Pre-Weigh operation.

SECTION 6: Scale Verification Procedure

Weighing equipment used during the Pre-Weigh operation must be verified prior to use to ensure measurement accuracy and suitability for the intended dispensing activity.

Verification requirements are governed by the Quality Control equipment verification requirement referenced in Section 1.2 (QC-ANL-002 – Instrument & System Suitability).

Verification results must be documented in the Batch Production Record (BPR) before Pre-Weigh activities begin.

6.1 Scale Verification

Prior to dispensing any component, the weighing device must be verified to confirm proper operation and measurement accuracy.

Scale readiness and setup must be completed in accordance with SOP-PROD-PREOP prior to performing scale verification.

Standard Procedure

1. 6.1.1 Verify that the scale calibration status is current and within the approved calibration due date.
2. 6.1.2 Inspect the scale to ensure it is clean, properly assembled, and suitable for use.
3. 6.1.3 Confirm that the scale is positioned on a stable and level surface and that environmental conditions are suitable for accurate weighing (e.g., absence of vibration, drafts, or air disturbance).
4. 6.1.4 Perform scale verification using certified check weights appropriate for the capacity and readability of the scale.
5. 6.1.5 Confirm that the measured value obtained during verification is within the acceptable tolerance defined in QC-ANL-002.
6. 6.1.6 Record the scale identification, check weight used, and verification results in the Batch Production Record prior to initiation of Pre-Weigh activities.
7. 6.1.7 If scale verification fails, remove the scale from service, notify Quality, and do not proceed with Pre-Weigh activities. Any material weighed using the scale since the last successful verification must be evaluated according to deviation procedures.

6.2 Minimum Measurable Weight

Each component must be weighed on a scale suitable for the target quantity being dispensed.

The minimum measurable weight for a scale must be at least ten (10) times the scale readability.

Standard Requirement

1. 6.2.1 Confirm that the target component weight meets or exceeds the minimum measurable weight of the scale selected for dispensing.
2. 6.2.2 If the target component weight is below the minimum measurable weight of the available scale, use a more sensitive balance or dispense the material as part of a validated pre-blend procedure.
3. 6.2.3 Under no circumstances may components be weighed below the minimum measurable weight of the scale used.

SECTION 7: Material Release Verification

Sampling and identity testing of incoming raw materials are performed during the Material Readiness process under oversight of the Quality Unit in accordance with QC-MAT-001 – Component Identity Verification and applicable Quality Control procedures.

These activities occur prior to release of materials for manufacturing use and are not performed as part of the Pre-Weigh operation.

Standard Requirement

1. 7.1 Prior to dispensing any component, verify that the material status in the ERP or inventory control system is designated as RELEASED.
2. 7.2 Materials identified as Quarantined, On Hold, Rejected, or otherwise not approved for production use must not be used in the Pre-Weigh operation.
3. 7.3 If the material release status cannot be verified, the Pre-Weigh operation must not proceed until the status is confirmed by the Quality Unit.

SECTION 8: Component Weighing Procedure

Components must be dispensed according to the quantities defined in the Pre-Weigh Batch Production Record generated for the manufacturing Work Order.

All weighing activities must be performed using verified equipment and must be documented in the Batch Production Record (BPR) at the time the activity is performed.

Only materials that have been released for production use by the Quality Unit may be dispensed during the Pre-Weigh operation.

8.1 Weighing Accuracy Requirements

Unless otherwise specified in the Approved Formula or Product Specification, the acceptable weighing tolerance during the Pre-Weigh operation is:

±1.0% of the target component weight

Standard Requirement

1. 8.1.1 Dispense each component to the target quantity defined in the Pre-Weigh Batch Production Record.
2. 8.1.2 Confirm that the dispensed quantity is within the allowable tolerance for the component.
3. 8.1.3 If the dispensed quantity falls outside the allowable tolerance, adjust the weight to within tolerance or re-dispense the component.
4. 8.1.4 Record all actual weights in the Batch Production Record at the time the weighing activity is performed.
5. 8.1.5 Any adjustment or re-dispensing activity must be documented in the Batch Production Record.

8.2 Component Weighing Procedure

The following procedure must be followed when dispensing each component listed in the Pre-Weigh Batch Production Record.

Standard Procedure

1. 8.2.1 Confirm that personnel performing the Pre-Weigh activity are trained and authorized according to the Manufacturing Training Program.
2. 8.2.2 Verify that the current approved revision of the Master Manufacturing Record (MMR) and applicable Product Specification are being used.
3. 8.2.3 Retrieve the ingredient list and required dispense quantities from the Pre-Weigh Batch Production Record associated with the manufacturing Work Order.
4. 8.2.4 Verify that the ingredient SKU and description match the Approved Formula.
5. 8.2.5 Confirm that the supplier lot number matches the lot identified in the Pre-Weigh Batch Production Record.
6. 8.2.6 Confirm that the material is within the approved expiration date or retest date.
7. 8.2.7 Inspect the material container and packaging for damage, contamination, or evidence of tampering.
8. 8.2.8 Verify that the dispensing container is empty, clean, and suitable for use.
9. 8.2.9 Confirm the dispensing container is dedicated or verified clean to prevent cross-contamination with previously handled materials.
10. 8.2.10 Determine and record the tare weight of the dispensing container in the Batch Production Record.
11. 8.2.11 Verify that the weighing scale selected is appropriate for the target component weight based on the minimum measurable weight requirement defined in Section 5.
12. 8.2.12 Dispense the target component weight according to the quantities defined in the Pre-Weigh Batch Production Record.
13. 8.2.13 Record the gross weight and calculated net weight in the Batch Production Record.
14. 8.2.14 An independent qualified individual must verify the following before the dispensed material leaves the Pre-Weigh area:
    • Correct ingredient identity
    • Correct supplier lot number
    • Dispensed weight within allowable tolerance
15. 8.2.15 The verifier must review the recorded weight and confirm accuracy by signing or initialing the Batch Production Record.
16. 8.2.16 Label the dispensed container with the following information:
    • SNL SKU
    • SNL Lot
    • Dispensed Net Weight
    • Date Dispensed
    • Operator Initials
17. 8.2.17 Ensure the label is clearly legible and securely affixed to the container.
18. 8.2.18 Only containers bearing complete identification may be staged for the next manufacturing step.

SECTION 9: Theoretical Yield

The theoretical yield for this product is defined in the approved manufacturing formula (Appendix A). Expected blend weight and capsule fill weight must match the values defined in the approved formula. Actual yield and reconciliation values must be recorded in the Batch Production Record (BPR) during manufacturing execution.

SECTION 10: Material Reconciliation

Material reconciliation ensures that the quantity of each component dispensed during the Pre-Weigh operation corresponds to the quantities defined in the Approved Formula and the Pre-Weigh Batch Production Record for the manufacturing batch.

Reconciliation must be completed for all dispensed components prior to authorization of the subsequent manufacturing step.

10.1 Material Reconciliation Procedure

Material reconciliation must be performed after completion of the Pre-Weigh dispensing activities and prior to release of materials to the next manufacturing step.

Standard Procedure

1. 10.1.1 Verify that the target quantity for each component matches the Approved Formula and the Pre-Weigh Batch Production Record.
2. 10.1.2 Review the actual dispensed net weight recorded in the Batch Production Record for each component.
3. 10.1.3 Calculate the variance between the target weight and the actual dispensed weight for each component.
4. 10.1.4 Confirm that the calculated variance is within the allowable weighing tolerance defined in Section 6 unless a different tolerance is specified in the Product Specification.
5. 10.1.5 Record reconciliation results in the Batch Production Record.
6. 10.1.6 If reconciliation results fall outside acceptable limits, stop progression of the manufacturing batch and initiate a deviation according to Section 11 – Deviation Handling.
7. 10.1.7 Where required by the Batch Production Record or Quality procedures, a qualified individual must review and verify reconciliation results prior to release of materials to the next manufacturing step.

SECTION 11: Acceptance Criteria

SECTION 12: Deviation Handling

A deviation must be initiated whenever manufacturing activities do not comply with the requirements defined in this Master Manufacturing Record, the Product Specification, or applicable Quality procedures.

Examples of events requiring deviation documentation include, but are not limited to:

• Incorrect material or incorrect component identity
• Dispensed weight outside allowable tolerance
• Equipment malfunction or verification failure
• Environmental conditions outside approved limits
• Process steps not executed as defined in this procedure

Deviations must be documented in the Quality Management System and evaluated by the Quality Unit prior to continuation of manufacturing activities.

12.1 Deviation Response Procedure

If a deviation or nonconformance occurs during the Pre-Weigh operation, the following actions must be performed.

Standard Procedure

1. 12.1.1 Stop the affected manufacturing activity and secure the process to prevent continuation of the operation.
2. 12.1.2 Segregate and clearly identify any affected materials to prevent unintended use in manufacturing.
3. 12.1.3 Notify the Quality Unit of the deviation or nonconformance.
4. 12.1.4 Initiate a deviation record in the Quality Management System in accordance with the established deviation management procedure.
5. 12.1.5 Document the deviation and any affected materials or equipment in the Batch Production Record.
6. 12.1.6 Manufacturing activities must not resume until the deviation has been reviewed and dispositioned by the Quality Unit and authorization to continue has been documented.

SECTION 13: Data Integrity Requirements (ALCOA+)

All data generated during execution of this procedure must comply with ALCOA+ data integrity principles and applicable Quality Management System requirements.

All records generated during manufacturing activities must be:

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate
• Complete
• Consistent
• Enduring
• Available

Entries in the Batch Production Record must be recorded at the time the activity is performed. Data must not be backdated or recorded in advance of the activity.

Corrections to recorded information must be made using a single line strike-through so that the original entry remains legible. Corrections must include the initials of the person making the correction, the date of correction, and the reason for the change where required by applicable procedures.

SECTION 14: Electronic Records and Signatures

Electronic systems used in the execution and documentation of this Master Manufacturing Record (MMR) must comply with applicable electronic record and electronic signature requirements where regulated manufacturing records are generated or maintained.

Electronic records generated during manufacturing execution are considered official manufacturing records when created, maintained, and approved within validated electronic systems operating under approved procedures.

Electronic signatures used within these systems must uniquely identify the individual performing the action and must be permanently linked to the corresponding electronic record. Electronic signatures must be attributable to a single individual and may not be shared.

All electronic systems used for manufacturing records must maintain secure, computer-generated, time-stamped audit trails that record the date, time, and user identity associated with the creation, modification, approval, or deletion of records.

Access to electronic systems must be restricted to authorized personnel through controlled user accounts and role-based permissions in accordance with established information technology and quality system procedures.