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.
Encapsulation 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, material eligibility, and blend uniformity controls applicable to this manufacturing stage.
Capsule Fill Control
Encapsulation operations introduce previously verified and released blend material into capsule shells in accordance with the approved Master Manufacturing Record (MMR) and product specifications maintained within the Quality Management System.
Capsule fill weight, capsule shell specification, and in-process weight verification are controlled according to the approved manufacturing instructions to ensure dosage uniformity and consistent finished product quality.
| QC Requirement | Applies To |
|---|---|
| QC-ENV-002 – Production Environmental Conditions | Section 2 – Environmental Requirements |
| QC-ANL-002 – Instrument & System Suitability (Timers / Measurement Systems) | Section 4 – Equipment & System Verification |
| QC-MAT-004 – Material Storage & Handling Acceptance | Section 5 – Component Transfer & Staging |
| QC-PRO-001 – Process Control & Uniformity Assurance | Section 6 – Blending Parameters & In-Process Verification |
Execution of the encapsulation operation must be documented in the Encapsulation Batch Production Record generated for the specific manufacturing Work Order.
The Batch Production Record defines the capsule product configuration, blend lot identification, capsule shell specifications, equipment configuration, and processing parameters required for execution of this procedure.
Operators must follow the instructions contained in the Master Manufacturing Record together with the formulation, component details, and processing parameters defined in the Encapsulation Batch Production Record for the specific Work Order.
All blend lot identification, capsule shell lot numbers, processing parameters, equipment identifications, operator identifications, and verification signatures must be recorded in the Batch Production Record at the time the activity is performed.
Environmental conditions during capsule filling 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 encapsulation 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 capsule filling 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 capsule filling activity, notify the Quality Unit, document the deviation, and resume operations only after Quality Unit authorization. | QC-ENV-002 |
| Area Cleanliness | Encapsulation area verified clean and line cleared prior to operation | Do not proceed. 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 capsule filling operations during the Encapsulation 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 |
|---|---|---|---|
| Target Capsule Fill Weight | As defined in the approved formulation and product specification | Approved Formula / Product Specification | |
| Capsule Size | Capsule shell size must match the size specified in the approved product specification | Product Specification | |
| Average Fill Weight Control | Maintain average fill weight within ±7.5% of the target fill weight | QC-PRO-001 / Product Specification | |
| In-Process Weight Check Frequency | Verify capsule fill weight at intervals specified in the Master Manufacturing Record throughout encapsulation operations | QC-PRO-001 / Master Manufacturing Record | |
| Capsule Fill Weight Sample Size | Sample size used to determine average fill weight must be equivalent to one finished unit (one bottle) of capsules unless otherwise defined in the product specification | QC-PRO-001 / Product Specification |
Encapsulation Material Handling
Released blend material must be transferred into the capsule filling equipment using clean, verified containers and staging procedures defined in the Master Manufacturing Record.
Capsule shells and blend material must be clearly identified with material name, lot number, and material status prior to use in encapsulation operations.
Material staging must occur only in the designated manufacturing staging area prior to capsule filling operations.
The following equipment is required for execution of the Encapsulation stage.
Equipment must be suitable for use, clean where applicable, and within required calibration or verification status prior to capsule filling operations.
Equipment readiness verification must be completed in accordance with SOP-PROD-PREOP – Pre-Operation Readiness & Line Clearance prior to performing encapsulation equipment verification or capsule filling activities.
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 Encapsulation stage when suitable for the intended operation.
| Equipment / Utensil | Requirement | Reference |
|---|---|---|
| Capsule Filling Machine | Capsule filling equipment must be clean, suitable for use, and verified ready for operation prior to encapsulation activities. | Equipment Cleaning Verification SOP |
| Capsule Filler Controls / Counters | Equipment controls, counters, timers, and operational indicators must be verified functional prior to operation. | QC-ANL-002 – Instrument & System Suitability |
| Capsule Feed System / Hoppers | Material contact surfaces must be clean, intact, and suitable for product contact. | Equipment Cleaning Verification SOP |
| Capsule Orientation / Separation System | Capsule orientation system must be verified operational to ensure proper capsule alignment prior to filling. | Equipment Operating Procedure |
| In-Process Weighing Scale | Scale used for in-process capsule weight verification must be within calibration status and verified suitable for use. | QC-ANL-002 – Instrument & System Suitability |
| Capsule Collection Containers / Liners | Containers used for encapsulated product collection and staging must be clean, intact, and suitable for product contact. | Equipment Cleaning Verification SOP |
Record the actual equipment assets used during execution of this Encapsulation 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 Encapsulation 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. Manufacturing 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 Encapsulation operation, the capsule filling 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 encapsulation 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 encapsulation activities.
Encapsulation equipment used during capsule filling 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 encapsulation activities.
Prior to loading blend material and capsule shells, the capsule filling equipment must be verified to confirm proper operation and readiness for manufacturing use.
Equipment readiness must be verified in accordance with SOP-PROD-PREOP prior to performing encapsulation equipment verification.
The weighing system used for capsule fill weight verification must be confirmed suitable for use prior to performing in-process weight checks.
Materials used during the Encapsulation operation must correspond to the materials specified in the approved Batch Production Record (BPR) for the current manufacturing batch.
Blend material used for encapsulation must originate from an approved Blending operation and must have been verified and released by the Quality Unit in accordance with applicable Quality Control procedures.
Capsule shells must meet the approved product specification and must be verified as suitable for use prior to initiation of encapsulation activities.
Encapsulation instructions for the specific manufacturing batch are generated from the approved product configuration and process parameters defined within the Quality Management System and provided as a controlled execution artifact associated with the Batch Production Record (BPR).
The encapsulation instruction artifact may be provided as either:
The instruction artifact is derived from approved product specification data, encapsulation process parameters, and applicable Quality Control requirements maintained within the Quality Management System.
The theoretical encapsulation yield for the manufacturing batch is derived from the approved formulation and target capsule fill weight defined in Appendix A – Approved Formula.
The expected number of capsules to be produced is calculated using the approved blend quantity and target fill weight. Actual capsule yield and reconciliation values must be recorded in the Batch Production Record (BPR) upon completion of encapsulation 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 steps.
| Parameter | Reference |
|---|---|
| Total Theoretical Capsule Quantity | Derived from Appendix A – Approved Formula and Target Fill Weight |
| Actual Capsules Produced | Recorded in the Batch Production Record (BPR) |
| Acceptable Yield Range | Defined by formulation tolerance and applicable process specifications |
Encapsulation reconciliation ensures that all materials used during the encapsulation operation are properly accounted for and that the total number of capsules produced corresponds to the theoretical encapsulation yield defined in Section 9.
Reconciliation must be completed upon completion of encapsulation operations and prior to transfer of the encapsulated product to the next manufacturing step.
| Parameter | Description |
|---|---|
| Theoretical Capsule Quantity | Total expected capsule quantity derived from Appendix A – Approved Formula and target fill weight. |
| Actual Capsules Produced | Total number of capsules produced during encapsulation. |
| Rejected Capsules | Capsules removed during in-process inspection or machine rejection. |
| Remaining Blend | Residual blend material remaining after completion of encapsulation. |
| Variance | Difference between theoretical capsule quantity and reconciled capsule output. |
Encapsulation reconciliation must be performed after completion of encapsulation operations and prior to progression of the manufacturing batch to the next processing step.
| Parameter | Acceptance Criteria |
|---|---|
| Blend Material Verification | Blend material corresponds to the Batch Production Record, is properly labeled, and has been released for use by the Quality Unit. |
| Capsule Shell Verification | Capsule shells correspond to the approved product specification, are properly labeled with capsule size and lot number, and are approved for manufacturing use. |
| Encapsulation Equipment Verification | Capsule filling equipment and weighing systems are verified according to QC-ANL-002 and documented in the Batch Production Record. |
| Encapsulation Execution | Encapsulation is performed in accordance with the controlled execution instructions associated with the Batch Production Record. |
| In-Process Fill Weight Control | Average capsule fill weight is maintained within ±7.5% of target fill weight and verified according to QC-PRO-001 and defined in-process control procedures. |
| Encapsulation Yield | Actual capsule quantity is within the acceptable yield range defined in Section 9 and the Approved Formula. |
| Encapsulation Reconciliation | Reconciliation is completed and documented in the Batch Production Record prior to transfer to the next manufacturing step. |
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 encapsulation 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.