| 1 | GMP controls | Confirm that documented controls cover the capsule-shell manufacturing activities and intended pharmaceutical use. GMP obligations depend on the applicable jurisdiction and product. | Current quality procedures, audit records, training records, and applicable regulatory inspection or compliance information. | Define the applicable GMP expectations in the quality agreement; do not treat one certificate as proof of compliance in every market. |
| 2 | ISO 15378:2017 quality system | Check whether certification is valid and whether its stated scope covers the relevant primary packaging materials, manufacturing site, and processes. ISO 15378:2017 combines quality-management requirements with GMP-related requirements for medicinal-product primary packaging materials. | Certificate, certification scope, issuing certification body, validity dates, and site details. | Verify the certificate with its issuer and confirm that the supplied product and production location fall within its scope. |
| 3 | Material identity and composition | Establish whether the shell is gelatin-based or made from another material, such as hypromellose, and review declared ingredients, colorants, and relevant allergen or animal-origin information. | Product specification, ingredient declaration, material-origin statements, and applicable certificates or supporting documentation. | Match material and ingredient requirements to the formulation, target market, and customer labeling obligations. |
| 4 | Size and dimensional consistency | Confirm the requested capsule size and the supplier’s controlled dimensions and tolerances for the cap and body. Capsule dimensions can vary by size and specification. | Approved drawings or dimensional specifications, sampling plan, and batch inspection results. | Run filling-line compatibility trials before approving a new size, material, or supplier. |
| 5 | Performance and compendial requirements | Identify applicable disintegration, dissolution, and other performance requirements for the finished product and target markets. Requirements depend on the product, formulation, and governing compendium or regulation. | Test methods, validation or qualification information where applicable, and representative test results against agreed specifications. | Agree test methods and acceptance criteria in advance; assess the filled dosage form where performance depends on the formulation. |
| 6 | Defect control and visual quality | Review controls for defects such as cracks, splits, dents, deformation, poor joining, and contamination, using mutually agreed defect definitions and limits. | Inspection procedure, defect classification, sampling plan, and batch-level inspection records. | Document critical, major, and minor defect criteria and the process for handling rejected or nonconforming lots. |
| 7 | Batch traceability and documentation | Ensure each shipment can be linked to a production batch and that records support investigation, complaint handling, and recall activities. | Batch numbering system, certificate of analysis or conformity as agreed, and documented traceability or recall procedures. | Check that batch identifiers on labels and shipping documents match the accompanying quality records. |
| 8 | Change control | Assess how changes to materials, processes, equipment, facilities, specifications, or testing are evaluated and communicated. | Written change-control procedure and examples of customer notification and impact assessment, where available. | Set notification timelines and customer approval requirements for changes that may affect quality or regulatory filings. |
| 9 | Packaging, storage, and transport | Confirm that packaging and storage conditions protect capsules from contamination and unsuitable environmental exposure during storage and shipment. | Packaging specification, storage instructions, shipment protection details, and relevant stability or handling information. | Validate receiving and warehouse conditions against the supplier’s documented instructions and the buyer’s quality system. |
| 10 | Market and regulatory documentation | Determine which declarations and records are needed for the intended markets, including material composition, applicable food-contact or medicinal-product requirements, and customer-specific documentation. | Market-specific declarations, technical documentation, and supporting evidence appropriate to the product and destination jurisdiction. | Have regulatory and quality teams review documents for the destination markets; requirements are not identical worldwide. |