ISO 15378
ISO 15378 primary pharmaceutical packaging quality and GMP support
ISO 15378 consulting helps designers, manufacturers and suppliers of primary pharmaceutical packaging connect quality controls, GMP practices and batch records. Vosurein starts with the scope, existing processes and evidence, then helps assign responsibilities, implement the system and review it internally.
Discuss ISO 15378 Primary Pharmaceutical Packaging Quality and GMP consulting needs
For Your Business
Who this service is for and when to start
This service is for organisations designing, manufacturing or supplying primary pharmaceutical packaging. Start by identifying gaps when records of contamination controls, material mix-up prevention, changes and batch release are not connected.
The Challenge
Common challenges faced by businesses
When the same packaging material goes to several pharmaceutical manufacturers, cleaning, batch-release and change-notification conditions may differ. Dimensional inspections alone do not address contamination, material mix-ups or supplier changes. Link these controls to quality agreements so investigations can identify affected batches.
Our Approach
Methods and applicable requirements
The applicable edition is ISO 15378:2017 with Amd 1:2024. The 2017 publication is the fourth edition, following the 2015 edition.
ISO 15378 sets particular requirements for applying ISO 9001:2015 to primary pharmaceutical packaging, with reference to GMP. Intended use, contamination risks and quality agreements determine the depth of control. Outer packaging and materials in direct contact with medicines do not automatically share the same scope.
The following consulting tasks can be arranged to suit your needs.
Current-state and gap analysis
Review products, processes, sites, customer requirements and gaps in the management system.
Quality documentation and responsibilities
Plan procedures, records, document version control and quality responsibilities.
Personnel, environment and contamination control
Review hygiene, cleaning, the working environment, material mix-up prevention and foreign-matter controls according to risk.
Supplier and outsourcing management
Organize raw material and outsourcing evaluations, specifications, quality agreements, and change notifications.
Production, inspection, and traceability
Review batch identification, production records, inspection, release, storage and delivery.
Equipment and validation planning
Identify applicable assessment or validation needs for equipment, processes, cleaning and computerised systems.
Deviation and Quality Improvement
Integration of nonconformities, deviations, customer complaints, corrective actions, and recall arrangements.
Training and internal review
Support system pilots, internal audits, management reviews and certification preparation.
Process
Consulting scope and process
Review packaging uses and quality agreements
Confirm the use of packaging materials, drug contact relationships, and customer quality agreements, and distinguish the cleaning, change notifications, and release conditions for different products.
Define contamination controls and process responsibilities
Assess contamination, material mix-up and foreign-matter risks for each process. Assign personnel hygiene, equipment and supplier controls to the people responsible for carrying them out.
Batch Release and Change Process Trial
Check production, inspection, and release data batch by batch, confirm that material or process changes have undergone review and client communication, and organize validation requirements.
Deviation Traceability and Management Review
Trace affected batches and improvement measures from deviations and customer complaints, review whether controls are effective, and compile quality information needed for management review.
Preparation
What documents do companies need to prepare?
- Packaging Material Use: Material, mode of drug contact, and customer specifications.
- Process Environment: Procedures, cleaning, equipment, and environmental control.
- Supply Quality: Raw materials, outsourcing, quality agreements, and changes.
- Batch Evidence: Production, inspection, release, deviations, and traceability.
For the initial discussion, you can provide a summary. Handle customer, personal and confidential business information within the necessary scope and agreed access permissions.
Project Planning
Estimating time and cost
Scope and cost mainly depend on packaging materials, processes, customer requirements and the number of sites. Allow appropriate time separately for cleaning, process or computerised system validation.
Management system consulting connects quality and GMP controls. Laboratory tests, equipment engineering, technical validation work and third-party certification are quoted separately as needed.
FAQ
Frequently asked questions
Does this apply to all packaging materials?
Material use and drug contact relationships must be confirmed; not all outer cartons or packaging are uniformly included. This standard references ISO 9001:2015 and does not automatically update references due to other standard revisions.
Can existing systems and records be reused?
Existing material use, processes, cleaning, suppliers, batch, and inspection records can be reviewed first to confirm applicable periods, scope, and evidence quality, then fill gaps; rewriting all documents is not a prerequisite for implementation.
Do suppliers need to notify the customer when changing materials?
Check quality agreements and change procedures first. Assess the impact on packaging quality and intended use, then complete the agreed reviews and notifications. An unchanged part number is not sufficient evidence.
How are consulting and third-party certification responsibilities divided?
Vosurein supports system implementation and preparation but does not issue third-party certificates. Confirm the applicable certification scheme, accreditation scope, fees and schedule separately. A certificate does not constitute product approval or proof of compliance with every regulation.
Does obtaining a certificate equal pharmaceutical GMP approval?
No. This standard addresses quality management and GMP-related requirements for primary drug packaging materials. Manufacturing licensing, product testing, and customer approval still need to be confirmed separately.
Which version should be confirmed before implementation?
The applicable edition is ISO 15378:2017 with Amd 1:2024. The 2017 publication is the fourth edition, following 2015. Confirm the edition and transition arrangements required by customers and the assessment scheme. The publication date of a standard is separate from an organisation’s transition deadline.
Related
Related services and enquiries
Please provide the industry, activities, locations, main requirements, and expected completion time.Contact Vosurein
Content checked: . Applicable versions and requirements depend on the company’s circumstances.
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