What does ISO 15378 cover?
ISO 15378 brings ISO 9001 quality management together with good manufacturing practice considerations for primary pharmaceutical packaging. The focus is controlling processes that can affect packaging suitability and product safety.
Who it is for
Manufacturers of packaging materials intended for direct contact with medicinal products.
Key areas to understand
Start with these areas. Identify which requirements apply to your activities and who is responsible for them.
- 1Control contamination risks in packaging manufacture.
- 2Manage changes, validation and traceability.
- 3Maintain consistency with agreed customer specifications.
Evidence to prepare
This list is a starting point. Check the standard for all required documents. For each item, record who is responsible, the activity or site it relates to, and a recent example showing how it works.
- Packaging specifications and agreements
- Hygiene and contamination-control records
- Process validation evidence
- Batch traceability and release records
- Change assessments and customer notifications
Keep records that explain what was checked, which requirement was used and who checked it. Include any action taken when a requirement was not met. Link each record to the work it supports.
An internal audit example
Suggested checks from 4Auditee
Trace one released batch of closures or containers through raw materials, production and inspection. Compare the conditions used with approved specifications and validated arrangements. If the process changed, check the documented assessment before release.
Choose a sample that suits your activities and risks. If you find a gap, record the requirement, the evidence and what was missing. Check more examples if the first results suggest a wider problem.
A common problem to check
A general ISO 9001 system may not address the packaging-specific contamination and GMP risks. Examine the actual manufacturing environment and product contact.
Prepare for assessment
The assessment type for this guide is management-system certification. Confirm the requirements, what will be assessed and how the assessment will work with the responsible body or customer. These steps help you prepare. You must also follow the scheme’s official rules.
- Define what is covered. List the products, services, activities and sites. Record the standard edition, additional scheme rules and customer requirements.
- Find what is missing. Compare the requirements with current work. Prioritise gaps by risk. Assign someone responsible and a completion date.
- Keep records of everyday work. Check a sample of actual records and speak with the people involved. Make sure they understand their responsibilities.
- Check the results. Complete internal reviews and audits. Check that corrective actions worked before closing problems.
From one site to many
Make it easy to find who is responsible at each site. Keep company policies separate from records of local work. Link each site’s records to its activities, risks and requirements so you can spot gaps at individual sites.
Sites that share a management system do not automatically qualify for one certificate or assessment. Confirm which sites can be included and how they will be checked with the assessment body.
About this guide and its sources
4Auditee wrote this guide using the public source below. The evidence list, audit example and preparation steps are our suggestions. Read the official standard and scheme rules for the full requirements. This guide does not include the standard’s full text or provide certification.
DQS: ISO 15378 reference information