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 Filling Encapsualtion 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 Filling Encapsulation 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.
The following controlled documents and system records provide the authoritative product and batch information required for execution of this procedure.
The following information is automatically populated from the Jira order and provides the operational context for the manufacturing batch.
Packaging 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.
Quality Unit authorization confirms that all required core documents are present and the Manufacturing Formula is in Approved status before Encapsulation operations may begin.
Identifies the Quality Control requirements governing environmental conditions, equipment verification, packaging component eligibility, labeling control, and packaging reconciliation applicable to this manufacturing stage.
Packaging Component Control
Packaging operations package finished product into controlled packaging configurations using approved packaging components including containers, closures, labels, inserts, and other packaging materials in accordance with the approved Master Manufacturing Record (MMR) and product specification maintained within the Quality Management System.
Only packaging components that meet approved specifications and have been released by the Quality Unit may be introduced into the packaging process. Packaging configuration, labeling accuracy, and packaging component identification must be verified prior to packaging operations to prevent product mislabeling, component mix-ups, or incorrect packaging configuration.
Line clearance procedures and packaging component verification controls must ensure that only the materials specified in the Packaging Batch Production Record are present in the packaging area for the current manufacturing batch.
Packaging operations must ensure that the correct finished product, correct packaging components, and correct labeling are used for the manufacturing batch as defined in the Packaging Batch Production Record.
| QC Requirement | Applies To |
|---|---|
| QC-ENV-002 – Production Environmental Conditions | Section 2 – Environmental Requirements |
| QC-ANL-002 – Instrument & System Suitability (Counters / Measurement Systems) | Section 4 – Equipment & System Verification |
| QC-MAT-004 – Material Storage & Handling Acceptance | Section 7 – Packaging Material Verification |
| QC-LBL-001 – Label Control & Artwork Verification | Section 8 – Packaging Execution Instructions |
| QC-PRO-003 – Packaging Process Control & Reconciliation | Section 9 – Packaging Yield & Section 10 – Packaging Reconciliation |
Execution of the packaging operation must be documented in the Packaging Batch Production Record generated for the specific manufacturing Work Order.
The Batch Production Record defines the packaging configuration, finished product lot identification, packaging component specifications, equipment configuration, and packaging parameters required for execution of this procedure.
Operators must follow the instructions contained in the Master Manufacturing Record together with the packaging configuration, component details, and packaging parameters defined in the Packaging Batch Production Record for the specific Work Order.
All finished product lot identification, packaging component lot numbers (including containers, closures, labels, and inserts), equipment identifications, operator identifications, and verification signatures must be recorded in the Batch Production Record at the time the activity is performed.
Packaging component issuance, usage, and reconciliation — including labels and other controlled packaging materials — must also be documented in the Batch Production Record to ensure complete accountability for packaging components used during the operation.
Environmental conditions during packaging operations 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 where packaging operations are performed.
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 packaging activity, notify the Quality Unit, document the deviation, and resume operations only after Quality Unit authorization. | QC-ENV-002 |
| Relative Humidity | 30–60 %RH | Stop packaging activity, notify the Quality Unit, document the deviation, and resume operations only after Quality Unit authorization. | QC-ENV-002 |
| Area Cleanliness | Packaging area verified clean, organized, and line cleared prior to operation | Do not proceed. Remove unrelated materials, packaging components, and labels from the area. Clean per approved sanitation SOP, re-verify area readiness, and document verification in the Batch Production Record. | Cleaning SOP |
The following process parameters represent the standard operating conditions for packaging operations during the Packaging 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 |
|---|---|---|---|
| Packaging Configuration | Packaging configuration must match the approved product specification and Packaging Batch Production Record | Product Specification / Packaging Batch Production Record | |
| Unit Count per Container | Each finished package must contain the unit count specified in the approved product specification | Product Specification | |
| Container / Closure Configuration | Container, closure, and any sealing components must match the approved packaging configuration | Product Specification / Packaging Batch Production Record | |
| Closure Application Verification | Closures must be applied and verified to ensure proper sealing and container integrity in accordance with approved packaging procedures | Packaging Procedure / Product Specification | |
| Label / Artwork Verification | Primary label and any secondary packaging components must match the approved labeling version for the specific product and manufacturing batch | QC-LBL-001 / Product Specification | |
| In-Process Packaging Verification Frequency | Packaging checks must be performed at intervals defined in the Packaging Batch Production Record throughout packaging operations | QC-PRO-003 / Packaging Batch Production Record | |
| Packaging Reconciliation Control | Issued packaging components, including labels and other controlled packaging materials, must be reconciled against finished packaged units at completion of the packaging operation | QC-PRO-003 |
Packaging Material Handling
Finished product and packaging components must be staged, identified, and handled in accordance with the approved Packaging Batch Production Record and applicable material handling procedures.
Containers, closures, labels, inserts, and other packaging components must be clearly identified with material name, lot number, and material status prior to use in packaging operations.
Packaging materials and finished product must be staged only in the designated packaging area for the current manufacturing batch.
Only the packaging components specified for the current batch may be present during the packaging operation. Unused, damaged, obsolete, or excess packaging components must be removed or segregated in accordance with approved procedures.
The following equipment is required for execution of the Packaging stage.
Equipment must be suitable for use, clean where applicable, and within required calibration or verification status prior to packaging operations.
Specific instrument and system suitability requirements are defined in QC-ANL-002 – Instrument & System Suitability.
Equipment identification and readiness verification results must be recorded in the Batch Production Record (BPR) or in the controlled execution record associated with this manufacturing batch.
The following equipment and utensils are approved for use in the Packaging stage when suitable for the intended operation.
| Equipment / Utensil | Requirement | Reference |
|---|---|---|
| Product Filling / Counting System | Packaging equipment used to fill containers or count units must be clean, suitable for use, properly configured, and verified ready for operation prior to packaging activities. | Equipment Cleaning Verification SOP |
| Packaging Line Controls / Counters | Equipment controls, counters, timers, sensors, and operational indicators must be verified functional prior to operation. | QC-ANL-002 – Instrument & System Suitability |
| Container Handling System | Container feed systems, staging equipment, and handling mechanisms must be verified operational and suitable for use prior to packaging operations. | Equipment Operating Procedure |
| Label Application System | Label application equipment must be verified operational and configured to apply the correct label version and placement for the product. | QC-LBL-001 – Label Control & Artwork Verification |
| Closure Application Equipment | Closure equipment must be capable of applying closures consistently and must be verified operational prior to packaging operations. | Packaging Procedure |
| In-Process Verification Scale (if applicable) | Scales used for in-process packaging verification must be within calibration status and verified suitable for use. | QC-ANL-002 – Instrument & System Suitability |
| Packaging Collection Bins / Trays / Totes | Collection and staging containers used during packaging must be clean, intact, and suitable for product contact or controlled handling as applicable. | Equipment Cleaning Verification SOP |
Record the actual equipment assets used during execution of this Packaging 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.
| Asset ID | Equipment Name |
|---|---|
Equipment that is damaged, visibly contaminated, or outside calibration or verification status must not be used.
Notify the Quality Unit and follow the established deviation procedures if required.
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 Packaging operation.
Line Start verification confirms that the manufacturing environment complies with the requirements defined in this Master Manufacturing Record (MMR) and that the packaging area is suitable for the current manufacturing batch.
Line Start authorization is documented within the approved electronic quality system. Packaging activities may begin only after Line Start verification has been completed and authorization has been granted by the Quality Unit.
Evidence of Line Start authorization is maintained within the electronic system and referenced in the associated Batch Production Record (BPR).
Prior to beginning the Packaging operation, the packaging 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 packaging area and prevents cross-batch mix-ups, incorrect labeling, and packaging configuration errors.
Completion of line clearance must be documented in the Batch Production Record (BPR) prior to initiation of packaging activities.
Packaging equipment used during packaging operations must be verified prior to use to ensure the equipment is suitable for the intended manufacturing activity and capable of operating within the required process parameters.
Verification requirements are governed by QC-ANL-002 – Instrument & System Suitability.
Verification results must be documented in the Batch Production Record (BPR) prior to initiation of packaging activities.
Prior to introducing finished product or packaging components, packaging equipment must be verified to confirm proper operation and readiness for manufacturing use.
Measurement systems used for packaging verification, including scales, counters, or other inspection systems where applicable, must be confirmed suitable for use prior to performing in-process packaging checks.
Materials used during the Packaging operation must correspond to the materials specified in the approved Packaging Batch Production Record (BPR) for the current manufacturing batch.
Finished product used for packaging must originate from an approved manufacturing stage and must have been verified and released by the Quality Unit in accordance with applicable Quality Control procedures.
Packaging components including containers, closures, labels, inserts, and other packaging materials must meet the approved product specification and must be verified as suitable for use prior to initiation of packaging activities.
Packaging instructions for the specific manufacturing batch are generated from the approved product configuration and packaging parameters defined within the Quality Management System and provided as a controlled execution artifact associated with the Packaging Batch Production Record (BPR).
The packaging instruction artifact may be provided as either:
The instruction artifact is derived from approved product specification data, packaging configuration parameters, and applicable Quality Control requirements maintained within the Quality Management System.
The theoretical packaging yield for the manufacturing batch is derived from the approved product configuration and packaging parameters defined in the Packaging Batch Production Record (BPR).
The expected number of finished packaged units is calculated using the approved finished product quantity and the defined unit count per container. Actual packaged units and reconciliation values must be recorded in the Packaging Batch Production Record upon completion of packaging operations.
Material discrepancies identified during reconciliation must be reported to the Quality Unit and investigated in accordance with applicable Quality procedures prior to continuation of subsequent manufacturing or distribution activities.
| Parameter | Reference |
|---|---|
| Total Theoretical Packaged Unit Quantity | Derived from Packaging Batch Production Record and approved packaging configuration |
| Actual Packaged Units Produced | Recorded in the Packaging Batch Production Record (BPR) |
| Acceptable Yield Range | Defined by packaging configuration tolerance and applicable process specifications |
Packaging reconciliation ensures that all packaging materials and finished packaged units used during the packaging operation are properly accounted for and that the total packaged output corresponds to the theoretical packaging yield defined in Section 9.
Reconciliation must be completed upon completion of packaging operations and prior to release or transfer of the packaged product to the next manufacturing or distribution step.
| Parameter | Description |
|---|---|
| Theoretical Packaged Unit Quantity | Total expected packaged unit quantity derived from the Packaging Batch Production Record and approved packaging configuration. |
| Actual Packaged Units Produced | Total number of finished packaged units produced during packaging. |
| Rejected Units | Packaged units removed during in-process inspection or packaging line rejection. |
| Unused Packaging Components | Packaging materials remaining after completion of packaging operations, including containers, closures, labels, inserts, and other controlled packaging materials. |
| Variance | Difference between theoretical packaged unit quantity and reconciled packaged output. |
Packaging reconciliation must be performed after completion of packaging operations and prior to progression of the manufacturing batch to the next processing or distribution step.
| Parameter | Acceptance Criteria |
|---|---|
| Finished Product Verification | Finished product corresponds to the Packaging Batch Production Record, is properly labeled with product identification and lot number, and has been released for use by the Quality Unit. |
| Packaging Component Verification | Packaging components including containers, closures, labels, inserts, and other packaging materials correspond to the approved product specification, are properly labeled with component identification and lot number, and are approved for manufacturing use. |
| Packaging Equipment Verification | Packaging equipment, counters, measurement systems, and verification scales are verified in accordance with QC-ANL-002 and documented in the Packaging Batch Production Record. |
| Packaging Execution | Packaging operations are performed in accordance with the controlled execution instructions associated with the Packaging Batch Production Record. |
| Packaging Configuration Verification | Finished packaged units conform to the approved packaging configuration including the correct container, closure, labeling, and unit count as defined in the product specification. |
| Packaging Yield | Actual packaged unit quantity is within the acceptable yield range defined in Section 9 and the Packaging Batch Production Record. |
| Packaging Reconciliation | Packaging component and packaged unit reconciliation is completed and documented in the Packaging Batch Production Record prior to release or transfer of the packaged product. |
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, the following:
Deviations must be documented in the Quality Management System and evaluated by the Quality Unit prior to continuation of manufacturing activities.
If a deviation or nonconformance occurs during the packaging operation, the following actions must be performed.
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:
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.
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.
| System | Purpose | Control Requirement |
|---|---|---|
| ERP / Inventory System | Generation of Work Orders and Batch Production Records | System access control, user authentication, and audit trail capability required |
| Quality Management System (Jira) | Document approval, deviation management, and quality oversight | Electronic approval workflow with traceable user identity and audit trail |
| Document Control System | Storage, revision control, and distribution of MMR documents | Controlled access, version history, and document approval controls |
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.