BRCGS Packaging Materials Issue 7: requirements, grades and where ISO 15378 fits for pharmaceutical packaging

By AGS Compliance Team 7 min read

BRCGS Packaging Materials Issue 7 is the current edition of the BRCGS Global Standard for packaging manufacturers. It was published on 28 October 2024, certification against it started on 28 April 2025, and each audited site receives a grade from AA to D based on the number and severity of non-conformities.

This guide is for quality and technical managers at packaging sites, including converters and printers who also supply medicine makers and need to know where ISO 15378 fits.

What is BRCGS Packaging Materials Issue 7 and who does it apply to?

BRCGS first published the Global Standard Packaging Materials in 2001 for companies supplying packaging to food producers. Issue 7 covers packaging used for food, beverages and feed, for hygiene-sensitive consumer products such as cosmetics and pharmaceuticals, and for single-use disposable products. It also applies to prior operations, such as making materials for later conversion or printing.

The standard is voluntary. Brand owners, retailers and food service companies ask for it when they approve packaging suppliers. In September 2026 BRCGS reported that more than 7,100 sites in 94 countries held certification to the standard, on its 25th anniversary news page.

BRCGS registers the certification bodies that audit sites. A site picks one from the BRCGS Directory and buys or downloads the standard from the BRCGS store, where a free PDF is offered. Every audited site must have access to an official copy.

What changed from Issue 6?

BRCGS lists the focus areas of Issue 7 in its introduction. In AGS's summary, they are these:

  • Updated requirements for hazard analysis and risk assessment.
  • More weight on product safety and quality culture.
  • Single-use and disposable products formally brought into scope.
  • Stronger allergen management.
  • A new blended announced audit that uses remote technology.
  • Alignment with the Global Food Safety Initiative (GFSI) benchmarking requirements.

Certificates issued after Issue 6 audits held before 28 April 2025 stayed valid for the period on the certificate. By now every recertification audit runs against Issue 7. BRCGS also notes that second-year audits raised critical non-conformities in hazard analysis implementation and in the effectiveness of internal audits.

What are the requirement sections and the fundamental clauses?

Part II of Issue 7 holds the requirements in seven sections. They are senior management commitment, hazard analysis and risk assessment, product safety and quality management, site standards, product and process control, personnel, and traded products. A site that buys in finished packaging and stores it without processing can exclude traded products from scope.

Five requirements are marked fundamental. They are senior management commitment and continual improvement (1.1), hazard analysis and risk assessment (section 2), specifications (3.4), internal audits (3.5) and traceability (3.10). A major non-conformity against the statement of intent of a fundamental clause means no certificate is issued from that audit.

Part III sets the audit protocol and Part IV the rules for certification and accreditation bodies. The annual frequency used throughout means within 12 months of the last time the task was done, so a recall test in January one year and December the next does not count.

How are sites audited and graded?

There are three audit options. The announced audit is agreed in advance and is fully on site. Even in this programme, one audit in every three years must be unannounced.

The blended announced audit splits the visit into a remote document review and an on-site audit, with no more than half the time remote. It is only available for recertification, not for a first audit.

The voluntary unannounced programme can fall anywhere in the last four months of the audit cycle. Its grades carry a plus sign, such as AA+.

Grades depend on critical, major and minor non-conformities. Grade AA allows up to five minors and no majors. Grades AA, A and B lead to the next audit in 12 months.

Grades C and D bring a 6-month cycle, and grade D always needs a revisit. Any critical non-conformity means no certificate. Corrective action evidence is due within 28 calendar days, or 90 days at a first audit.

Does a pharmaceutical packaging plant also need ISO 15378?

Often yes, because medicine makers apply good manufacturing practice (GMP) to their packaging suppliers. ISO 15378:2017 is the international standard for primary packaging materials for medicinal products. It applies ISO 9001:2015 and adds GMP requirements, with a climate action amendment published in 2024. Our ISO 15378 guide explains its requirements and edition status.

The two schemes are separate. Each has its own audit and its own certificate, so a site holding both has two certifications, not one combined scope. The table compares them.

Point BRCGS Packaging Materials Issue 7 ISO 15378:2017
Owner BRCGS ISO (technical committee ISO/TC 76)
Current edition Issue 7, published 28 October 2024, audits from 28 April 2025 Fourth edition 2017, confirmed in 2023, Amendment 1 in February 2024
Scope All packaging and packaging materials, including food, cosmetic and pharmaceutical uses Primary packaging materials in contact with medicinal products
Basis Hazard analysis and risk assessment, site standards and good manufacturing practice ISO 9001:2015 clauses 4 to 10 plus GMP requirements
Audit result Grade AA to D, or not certificated Certificate issued or not, with nonconformities to close
Audit rhythm Every 6 or 12 months by grade, one unannounced audit every three years Annual surveillance in a three-year cycle (reported by certification bodies)

ISO 9001:2015 is now withdrawn following the September 2026 publication of ISO 9001:2026, while ISO 15378:2017 has not yet been revised. Ask your certification body how it will audit ISO 15378 in the meantime. Our ISO 9001:2026 transition guide covers the new edition.

Can one documented system serve both standards?

Yes, if you keep track of what each audit asks for. Both expect a hazard or risk analysis, supplier approval, traceability, internal audit, corrective action, recall procedures and training records. Much of that paperwork can be shared.

The gaps are in emphasis. BRCGS grades the site and checks site standards closely, such as glass and brittle plastic control, pest control, product defence and hygiene. ISO 15378 adds pharmaceutical GMP habits, such as formal change control, deviation handling, validation and customer notification of changes.

If one certification body is registered for BRCGS and accredited for ISO 15378, ask whether it can plan the two audits together. The audits stay separate, but the visits can be closer in time. Food packaging suppliers can compare the food side in our BRCGS Food Safety Issue 9 guide.

What will a BRCGS auditor check on the factory floor?

The points below are AGS's practical reading of a typical Issue 7 audit at a converting or printing site. They are not quotations from the standard.

  • A hazard analysis that covers physical, chemical and microbiological hazards for each product type, with controls that are monitored.
  • Line clearance records between jobs, so no old print, labels or material reach the next order.
  • Glass, brittle plastic and hard material registers with regular inspections.
  • A traceability test from raw material lot to customer delivery, and a recall test within the last 12 months.
  • A product safety and quality culture plan with evidence it is working.
  • Internal audits that find real issues and lead to closed corrective actions.

How AGS can help

AGS has two kits for Issue 7, both in editable Microsoft Word.

Frequently asked questions

Is the BRCGS Packaging Materials standard free?

BRCGS offers Issue 7 as a free PDF in its store, alongside paid unlocked PDF and printed versions. It recommends reading the interpretation guideline alongside the standard.

When must a certificate be issued after the audit?

BRCGS states that the certification body issues the certificate within 42 calendar days of the first day of the audit, once the non-conformities are closed.

Does Issue 7 apply to single-use disposable products?

Yes. Issue 7 formally brought single-use disposable products into scope. BRCGS gives paper napkins as an example and points to items used in food service.

Will buying documents get a site certificated?

No. Certification depends on how the system runs on site and on the certification body's audit findings.

AGS provides independent documentation toolkits. This guide and the referenced kits are not affiliated with, endorsed by or approved by BRCGS, ISO or any certification body, and they do not guarantee any audit grade or certification outcome.

Reviewed October 2026. Facts checked against the sources current at publication.

AGS Compliance Team

Our toolkits and guides are written by practising auditors who assess management systems against ISO, BRCGS, HACCP and Halal schemes. Every document reflects what assessors actually look for.

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