1. Purpose
This SOP defines the procedures and controls for packaging and labeling of dietary supplement products at Welsdom Inc to ensure accuracy, compliance with regulatory requirements, and prevention of mix-ups or mislabeling.
2. Scope
Applies to all packaging and labeling operations for finished dietary supplement products (human and pet) manufactured by Welsdom Inc, including products under OEM brand names.
3. Responsibilities
- Production Manager – oversee all packaging and labeling operations; approve completed Batch Packing Records.
- Packaging Personnel – carry out packaging and labeling activities as per this SOP.
- Operations Manager – approve master label specifications; conduct label reconciliation review.
4. Label Requirements
All product labels must include: product name and description; brand name (Welsdom, Altuva, Manamunity, Launchlab, or Vegans Best Friend as applicable); batch/lot number; manufacturing and expiry date; net quantity/weight; ingredients; usage instructions/dosage; storage conditions; manufacturer name and address (Welsdom Inc, 11-151 Amber Street, Markham, Ontario); allergen declarations as applicable; and regulatory statements.
5. Procedure
5.1 Pre-Packaging Line Clearance
Before packaging begins, the Production Manager or designate performs a Line Clearance Check (Form PKG-01) verifying removal of all previous batch materials, labels and documents; equipment clean and working; correct packaging components and labels staged; BMR available. Line clearance is documented and signed before any packaging begins.
5.2 Label Verification
Labels are retrieved from the label store by the Production Manager only. The Packaging Operator and Production Manager independently verify the label against the Master Label Specification – product name, batch number, expiry date, correct brand, allergen declarations. Verification is documented in the Batch Packing Record (Form PKG-02).
5.3 Packaging Operations
Only approved and inspected packaging materials may be used. The first 5 units of each run are inspected and approved before full production (First Article Inspection). In-process checks every 30 minutes are documented in Form PKG-02: label placement accuracy, seal integrity, fill weight/count, expiry date legibility.
5.4 Label Reconciliation
At the end of each run, all labels (used, damaged, unused) are counted and reconciled: Labels Issued – Labels Used – Labels Damaged = Labels Returned. Any discrepancy greater than 0.1% must be investigated before the batch is released. Results are documented in Form PKG-02.
5.5 Finished Goods Identification and Storage
Completed packaging is labeled with product name, batch number and quantity, then transferred to finished goods storage. FIFO/FEFO applies. Temperature-controlled products go to refrigeration immediately and the temperature is logged.
6. Records
- Form PKG-01 – Line Clearance Checklist
- Form PKG-02 – Batch Packing Record (BPR)
- Master Label Specifications
Records are retained for a minimum of 2 years after product expiry date.