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.
Identifies the Primary Jira Order governing the manufacturing activity and any associated Secondary Jira Orders. These orders establish the operational authorization and traceability for the manufacturing work being performed.
| Order Type | Jira Order ID | Open |
|---|---|---|
| Primary Order | ||
| Secondary Order | ||
| Secondary Order | ||
| Secondary Order |
The following product-specific documents define the formulation, material quantities, and manufacturing parameters required to perform the Pre-Weigh stage. These documents are controlled records and must correspond to the approved product specification and manufacturing work order.
| Ref | Document | Document ID | Version |
|---|---|---|---|
| A | Product Specification | ||
| B | Approved Formula | ||
| C | Wherefour Pre-Weigh Report |
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.
| QC Requirement | Applies To |
|---|---|
| QC-ENV-002 – Production Environmental Conditions | Section 2 – Environmental Requirements |
| QC-ANL-002 – Instrument & System Suitability (Balances / Measurement Systems) | Section 5 – Scale Verification |
| QC-MAT-001 – Component Identity Verification | Section 6 – Material Verification |
| QC-MAT-004 – Material Storage & Handling Acceptance | Sections 6 & 10 – Component Verification and Acceptance Criteria |
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.
Each execution of this Pre-Weigh procedure must be associated with a specific manufacturing Work Order or Batch ID generated by the ERP system. The Work Order establishes traceability between the approved formula, the Master Manufacturing Record (MMR), the Pre-Weigh Batch Record, and all subsequent manufacturing batch records.
| Traceability Item | Description |
|---|---|
| ERP Work Order | Manufacturing Work Order generated by the ERP system. |
| Manufacturing Batch ID | Unique identifier assigned to the batch being manufactured. |
| Pre-Weigh Batch Record | System-generated pre-weigh record associated with the Work Order. |
| MMR Reference | This MMR revision governs execution of the Pre-Weigh stage. |
The Work Order number and Batch ID must be recorded in the Batch Production Record and associated electronic systems to ensure complete traceability of materials, equipment, and manufacturing activities.
This Master Manufacturing Record (MMR) references controlled documents and system-generated records that define product formulation, material requirements, and quality control specifications. These documents are the authoritative source of the information referenced within this MMR. They are maintained and controlled within their respective systems of record. To ensure data integrity and prevent transcription errors, manufacturing personnel must reference these source documents directly rather than manually transcribing data into this MMR.
| Reference | Document / Record | System of Record | Control Authority |
|---|---|---|---|
| A | Approved Manufacturing Formula | Product Specification System | R&D / Product Development |
| B | Pre-Weigh Batch Record | Wherefour ERP | Manufacturing / ERP System |
| C | QC Requirement Index | Quality Management System | Quality Unit |
At the time of batch execution, operators must verify that the current approved version of each referenced document or record is being used. If a referenced document revision changes, the impact on this MMR must be evaluated through the document control process prior to manufacturing execution.
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.
| Parameter | Facility Operating Limit | Action if Not Met | Reference |
|---|---|---|---|
| Temperature | 64–77 °F | Stop activity, notify Quality, document deviation; resume only after QA authorization. | QC-ENV-002 |
| Relative Humidity | 30–60 %RH | Stop activity, notify Quality, document deviation; resume only after QA authorization. | QC-ENV-002 |
| Area Cleanliness | Manufacturing area verified clean prior to operation | Do not proceed. Clean per SOP, re-verify, and document in BPR. | Cleaning SOP |
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.
| Parameter | Default Process Requirement | Product Specification Override | Reference |
|---|---|---|---|
| Temperature | 64–77 °F | Product Specification | |
| Humidity | 30–60 %RH | Product Specification | |
| Weighing Tolerance | ±1.0% of target weight | Approved Formula | |
| Minimum Measurable Weight Rule | 10 × scale readability | QC-ANL-002 | |
| Maximum Pre-Weigh Hold Time | 24 hours before blending | Product Specification |
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. Specific verification criteria are defined in the Quality Control requirements referenced in Section 1.2. Equipment identification and verification results are recorded in the Batch Production Record (BPR).
| Equipment | Requirement | Reference |
|---|---|---|
| Weighing Scale | Scale must be calibrated and verified prior to pre weigh activities. | QC-ANL-002 – Instrument & System Suitability |
| Certified Check Weights | Certified weights suitable for the scale capacity must be available for verification. | Section 5 – Scale Verification Procedure |
| pre weigh Containers / Liners | Containers must be clean, intact, and suitable for material contact. | Equipment Cleaning SOP (Section 1.1) |
Equipment that is damaged, visibly contaminated, or outside calibration / verification status must not be used. Notify Quality and follow deviation procedures if required.
Prior to initiation of production operations, a qualified individual must perform a Line Start verification confirming that the manufacturing area, equipment readiness, environmental conditions, and documentation requirements defined in this MMR are acceptable for execution. Line Start authorization is documented within the approved electronic quality system (Jira). Production operations 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 in the Batch Production Record (BPR).
Before beginning the Pre-Weigh operation, the Pre-Weigh area must be verified as clear of materials, components, documentation, and equipment associated with previous manufacturing operations. Line clearance ensures that only materials and equipment required for the current batch are present in the Pre-Weigh area and prevents cross-batch mix-ups or contamination. Completion of line clearance must be documented in the Batch Production Record (BPR).
Weighing equipment used for pre weigh must be verified prior to use to ensure measurement accuracy. 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.
Only materials that have been released by the Quality Unit may be used in the Pre-Weigh operation. Prior to dispensing any component, personnel must verify that the material status in the ERP or inventory control system is designated as RELEASED for production use. Material release is performed by the Quality Unit in accordance with QC-MAT-001 – Component Identity Verification and the Material Release procedure. Materials identified as Quarantined, On Hold, Rejected, or otherwise not approved for use must not be dispensed. If the material status cannot be verified or is not confirmed as RELEASED, the Pre-Weigh operation must not proceed until the status is confirmed by the Quality Unit.
| Sampling Step | Requirement |
|---|---|
| Component Identity | Identity verification is performed by the Quality Unit according to QC-MAT-001 prior to material release. Only materials with ERP status RELEASED may be used in manufacturing. |
| Process Verification | Collect sample per QC sampling procedure if verification testing is required. |
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.
| Parameter | Reference |
|---|---|
| Total Theoretical Blend Weight | Defined in Appendix A – Approved Formula |
| Capsule Fill Weight | Defined in Appendix A – Manufacturing Specification |
| Acceptable Yield Range | Defined by formula tolerance and process specifications |
| Parameter | Description |
|---|---|
| Target Weight | Formula target weight |
| Actual Weight | Measured dispensed weight |
| Variance | Actual minus Target |
| Parameter | Acceptance Criteria |
|---|---|
| Material Identity | Matches approved SKU |
| Material Status | ERP status RELEASED |
| Dispensed Weight | Within formula tolerance |
| Scale Verification | Verification passed |
Electronic systems used in the execution and documentation of this Master Manufacturing Record (MMR) must comply with applicable electronic record and signature requirements. Systems used to generate, approve, or store manufacturing records include enterprise resource planning (ERP) systems, quality management systems, and electronic document control platforms.
| System | Purpose | Control Requirement |
|---|---|---|
| ERP / Inventory System | Generation of Work Orders and Pre-Weigh Batch Records | System access control and audit trail required |
| Quality Management System (Jira) | Document approval and deviation management | Electronic approval workflow with traceable user identity |
| Document Control System | Storage and revision control of MMR documents | Controlled access and version history |
Electronic records generated by these systems constitute the official manufacturing records when executed under approved procedures. Electronic signatures used within these systems must uniquely identify the individual performing the action and must be linked to the corresponding electronic record. All systems must maintain secure, computer-generated audit trails that record the date, time, and user identity associated with record creation, modification, and approval.
This Master Manufacturing Record (MMR) is a controlled document. Review and approval are performed electronically within the Quality Management System (Jira). Quality Assurance (QA) performs document review and the Quality Unit (QU) provides final approval prior to release for manufacturing use.
| Approval Role | Responsible Group | Jira Issue ID | Status |
|---|---|---|---|
| Document Review | Quality Assurance (QA) | ||
| Final Approval | Quality Unit (QU) |
Execution of this MMR is permitted only when the associated Jira approval record indicates Approved status.
| Version | Date | Description |
|---|---|---|