Cosmetics Good Manufacturing Practices

Cosmetics Good Manufacturing Practices: US, Europe, and Australia

Welcome to our guide on Cosmetics Good Manufacturing Practices (GMP) across the globe, focusing on three key regions: the United States, Europe, and Australia. GMP guidelines are crucial regulatory requirements that ensure consistent product quality, safety, and effectiveness.

Cosmetics Good Manufacturing Practice for the United States

In the US, the Food and Drug Administration (FDA) does not have specific GMP regulations for cosmetics, but it strongly advises manufacturers to adhere to GMP principles. Cosmetic manufacturers are encouraged to follow the guidelines issued by the International Cooperation on Cosmetics Regulation (ICCR), the FDA’s Cosmetic Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist, or other recognized industry GMP systems.

Key aspects covered by these guidelines include cleanliness, personnel qualifications, record keeping, equipment maintenance, and complaint handling. The overall goal is to prevent product contamination and ensure accurate labeling and consistent product quality.

Cosmetics Good Manufacturing Practice for Europe

In Europe, GMP for cosmetics is governed by Regulation (EC) No 1223/2009 of the European Parliament. In addition, the European Federation for Cosmetic Ingredients (EFfCI) provides GMP guidelines specifically for cosmetic ingredients.

The regulation covers aspects such as safety assessments, prohibited substances, product labeling, and notification procedures. European GMP standards are considered among the most stringent in the world, demanding comprehensive documentation and rigorous product testing.

Cosmetics Good Manufacturing Practice for Australia

In Australia, cosmetics are primarily regulated by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), a part of the Department of Health. Cosmetic manufacturers are advised to follow the Australian code of GMP, which aligns with the principles of the PIC/S Guide to GMP or the internationally accepted Cosmetics GMP, ISO 22716 which is accepted for all cosmetic products across the globe.

GMP Compliance: A Shared Responsibility

Regardless of the region, GMP for cosmetics serves to protect consumers and uphold product integrity. Implementing GMP involves the collective effort of everyone involved in the manufacturing process. Understanding and applying these regulations is not just about achieving compliance; it’s about building a culture of quality, safety, and trust in your cosmetics brand.

Remember, when it comes to cosmetics safety and quality, GMP is your pathway to trust, credibility, and customer satisfaction. Embrace it, and let your brand shine!

PharmOut have helped a number of cosmetics companies set up manufacturing facilities from scratch, i.e. from the initial designing and building of the facilities all the way to setting up document management systems, validating equipment, starting production and achieving Cosmetics GMP compliance.

For cosmetics, we work to the internationally accepted Cosmetics GMP, ISO 22716 and often PIC/S GMPs which can be used for all cosmetic products across the globe.

This standard has been effective since July 11, 2013 and has become mandatory – for example, the European Union’s new regulation, EC No. 1223/2009, has replaced the Cosmetics Directive, 76/768/EEC. This has been adopted by the USA, European Union (EU), Canada and Japan.

The EU regulatory framework goes on to state that:

“…in accordance with the relevant harmonised standards, the manufacture of cosmetic products shall comply with the principles of GMP and cosmetic products must be safe when used under normal or reasonably foreseeable conditions.

We offer:

GMP Consulting

PharmOut can provide experienced GMP consultants to help you navigate through ISO 22716 – essential for the manufacture of Cosmetics.

Facility Design Review

If you are building a new facility or refurbishing an old one, it’s important to have the plans independently reviewed to ensure that they meet current Cosmetics GMP requirements.

GMP Compliance Audits

To prepare for an official regulatory audit, it’s wise to have a pre-audit performed by one our consultants to check the GMP ‘health’ of your facility. This way you can find and address any problems you might have well in advance.

GMP Project Management

If you’ve got a huge project looming in the distance and don’t know where to begin, we also offer project management services to help you get production up and running as well as complying with the relevant regulations.

GMP Training

PharmOut has a large collection of online training modules and offers a variety of training options to suit your needs in the form of public courses, eLearning and on-site.

Interim QA Managers and QA Staff

If you’re short on staff or resource-poor, we can help you find temporary or permanent staff with the specific technical skills and experience that you require to move forward.

Quality Management Systems

PharmOut can provide QMS templates as well as experienced technical writers to capture your processes and policies.

Validation Services

We offer a full range of validation services – from cleaning and process validation all the way to equipment and computer systems validation.

More Information on Cosmetics GMP

We find that ISO 22716, the guidelines for Cosmetics GMP, gives essential, practical, hands-on advice which is focused specifically on human, technical and administrative factors affecting product quality. The prime objective of the guidelines is to define the activities which lead to the final product corresponding to the expected specifications, and therefore product safety.

Key elements of ISO22716 include, but are not limited to:

  • Quality structure, organisation and responsibilities
  • Personnel and training
  • Hygiene
  • Internal audit, CAPA (continuous improvement)
  • Vendor assurance
  • Materials management
  • Laboratory testing
  • Labeling
  • Shipment / distribution

ISO 22716 sets a very high requirements to ensure users’ safety, which is that main benefit of the Cosmetics Good Manufacturing Practices as described by the ISO 22716 standard.

FDA Cosmetics GMP

This FDA guidance covers the basics of Good Manufacturing Practices for Cosmetics, and covers the following essential principles.

  • Specific Guidance for Cosmetics
  • Documentation
  • Records
  • Buildings and Facilities
  • Equipment
  • Personnel
  • Raw Materials Water Color Additives Prohibited and Restricted Cosmetic Ingredients
  • Production
  • Laboratory Controls
  • Internal Audit
  • Complaints, Adverse Events, and Recalls

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