EVERYTHING YOU SHOULD KNOW ABOUT COSMETIC GMP (GOOD MANUFACTURING PRACTICES)

Estimated Reading Time: 6 minutes

IN ESSENCE…

• Good Manufacturing Practices for cosmetic products (also called cosmetic GMP or cosmetic GMPs) help businesses identify and mitigate the risks associated with production that can impact product safety and quality.
• As a quality assurance practice, cosmetic GMP assists in proactively controlling production variables to consistently give rise to high-quality products.
• Whether or not cosmetic GMP forms part of legal regulations can differ from region to region; in the US and Canada, implementing GMP standards is not mandatory but highly encouraged by the FDA and Health Canada, respectively.
• The ISO 22716 guidelines form the internationally accepted standard related to cosmetic GMP; countries such as the US, Canada, and those within the EU incorporate ISO 22716 guidelines within their own cosmetic GMP recommendations or regulations.
• Cosmetic GMP guidelines contain advice relevant for cosmetic businesses and can include areas such as documentation and records, equipment, personnel, laboratory controls, as well as product complaints and adverse events.

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INTRODUCTION

The success of all cosmetic businesses relies on its capacity to produce effective, safe, high-quality, and reputable products. Whether you have a big cosmetic line or a small skincare business making products at home, understanding the basics of Good Manufacturing Practices (GMP) can be immensely beneficial.

Many beauty brands get anxious when thinking about GMP, and some may view it as a complicated rule book rather than a positive resource designed to help businesses succeed. Indeed, GMP goes beyond just safety and contamination; it is about gaining awareness of, and having the ability to control, all the various factors that influence the eventual quality of a finished product. When implemented, GMP supports continuous improvements that ultimately result in enhanced customer satisfaction and brand loyalty.

Those making and selling homemade cosmetics are likely already following a quality system, although this may be in a more informal sense. No matter how small your cosmetic business is, awareness of GMP can help spearhead effective quality assurance practices that lead to better business and brand confidence.

Read on to discover what exactly cosmetic GMP is, why it’s helpful for your business, the regulations and international standards linked to cosmetic GMP, and the major areas the guidelines cover.

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WHAT IS COSMETIC GMP (GOOD MANUFACTURING PRACTICES)?

Cosmetic Good Manufacturing Practices (GMP) relate to a set of comprehensive guidelines that help cosmetic businesses consistently manufacture products that are safe and of high quality. The word ‘cosmetic’ here refers to goods or materials intended to alter, enhance, cleanse, or groom one’s face or body. They can range from makeup and fragrances to products such as soap, lip balms, shower gels, creams, lotions, body powders, and hair products. Apart from cosmetics, Good Manufacturing Practices also exist for other consumer products including food, drugs, and supplements.

GMP is sometimes also called ‘cGMP’. This refers to current Good Manufacturing Practices, which emphasizes the need for companies to adopt tools and technologies that are consistent with today’s standards.

As its name implies, GMPs are concerned with the manufacturing or production processes that impact the safety, consistency, and quality of the end product. Every cosmetic business has a responsibility to ensure that products created and ultimately sold are safe, effective, and of consistently high quality. This need is linked to various regulations that govern the sale of cosmetic products. For instance, in the US, the Federal Food, Drug and Cosmetic Act (Section 301) enforced by the FDA forbids the sale of cosmetic products that are “adulterated” or “misbranded”. In Canada, the Food and Drugs Act (Sections 16 and 18) states that cosmetics sold must be produced and stored in clean, hygienic environments.

Safety refers to the prevention of unintentional contamination, spoilage, or misuse of final products that may cause undesirable reactions and other health effects. It can involve practices such as sourcing raw materials from a reputable supplier, ensuring facilities are cleaned appropriately, educating staff about regular hand washing, and proofreading labels before printing.

Consistency relates to the ability to control manufacturing variables and processes so that a consistent outcome is achieved each time. For example, the formulation used, the types of raw materials selected, the sanitation protocols followed, and the technical ability of the cosmetic chemist are just some of the variables that can influence product quality. Each, if not controlled, can lead to quality variations from batch to batch. Creating accurate and thorough documentation, and then following them through, is vital in reproducing product quality and achieving consistency.

Quality relates to a product’s ability to satisfy certain criteria based on its attributes and characteristics. The concept of ‘quality’ is often operationalized and defined according to objective requirements, such as color, odor, viscosity, and pH. It also encompasses issues such as safety and purity. GMP helps companies manufacture products that are consistently high in quality from batch to batch.

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COSMETIC GMP HELPS EMBED QUALITY INTO THE ENTIRE MANUFACTURING PROCESS

GMP is a part of quality assurance which ensures products are consistently produced and controlled to quality standards appropriate for their intended use. In this way, cosmetic GMP embeds operational rules and organizational guidelines into the entire production process, allowing businesses to continually enhance product quality while saving the costs associated with making production errors.

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IS IMPLEMENTING COSMETIC GMP MANDATORY?

Implementing GMP is an effective way of complying with legal regulations related to consumer safety and product quality. Adherence requirements to GMP for cosmetics, in particular, can however vary from region to region.

In certain countries, GMP for cosmetics is endorsed and highly encouraged by national authorities but are not mandatory. In the US, GMP is recommended for cosmetic businesses but it is not a legal requirement; this is why FDA’s cosmetic GMP guidelines emphasize that their recommendations are ‘non-binding’. Similarly, in Canada, cosmetic businesses are encouraged by Health Canada to follow GMPs as set out by the ISO 22716 standard.

In other regions, however, GMP is a legal requirement for cosmetic manufacturers. For example, in Europe, the Cosmetics Regulation (EC) 1223/2009 necessitates that any cosmetic product aimed at selling to the EU market must adhere to cosmetic GMP guidelines as outlined by the ISO 22716.

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WHAT ARE THE BENEFITS OF FOLLOWING GMP FOR A SKINCARE OR COSMETICS BUSINESS?

Establishing GMPs can provide cosmetics brands, including home or small businesses, the security, and confidence needed to assure that their products are safe. The benefits can also extend beyond legal compliance; GMPs ensure you provide premium-quality cosmetics that customers will love and be satisfied with, increasing sales, boosting reputation, and driving brand loyalty. Cosmetic GMP guidelines also allow brands to carry out their own inspections of current operations.

On the other hand, if GMPs are not implemented, some of the issues cosmetic businesses could run into include:

• Mix-ups in labels or cosmetic ingredients and other production errors.
• Equipment and tools getting contaminated.
• Staff unintentionally introducing germs into the facility (e.g. by working with an open wound, not using a hairnet, and so on).
• Raw materials (including water) not getting tested adequately for quality before use.
• Difficulty replicating manufacturing procedures due to lack of documentation, leading to unnecessary deviations in quality.
• Printing labels containing errors, misinformation, and/or not having the full required information.
• Selling products that are unintentionally harmful or hazardous, causing health issues or adverse skin reactions.
• Difficulty tracing and identifying potential issues that are causing customer complaints.

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THE ROLE OF ISO 22716 IN COSMETIC GMP

The ISO (International Organization for Standardization) is a non-governmental body that sets forth many internationally accepted standards across a wide range of industries. In 2007, the International Cooperation on Cosmetic Regulation (ICCR), formed by the US, Canada, EU, and Japan, decided that they would use this standard when recommending or publishing cosmetic GMP guidelines for each nation. The ISO 22716 guidelines, therefore, form the bedrock of cosmetic GMP when it comes to international standards.

In 2013, the FDA published its updated GMP guidelines, taking into account the recommendations stated in ISO 22716.

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AN OVERVIEW OF COSMETIC GOOD MANUFACTURING PRACTICES GUIDELINES

The following sections contain a general overview of some of the areas that may be relevant for a cosmetic business trying to implement GMP. Each section is designed to provide only a basic outline of the relevant issue and is not meant to be exhaustive. As regulations are always changing, it is best to visit the official websites of national authorities (such as FDA and Health Canada) for up-to-date information and guidelines.

It is important to note that GMP guidance documents typically list outcomes, and not necessarily what needs to be conducted in order to reach that outcome. For instance, the document may state that raw materials should be examined to make sure they are clean and meet quality criteria, but will not state how this should be achieved. Cosmetic businesses can, therefore, decide for themselves how the recommendations should be implemented, depending on their own needs and available resources.

Documentation & Records

The process of documentation refers to the act of writing down the many facets of how something is carried out or conducted. The resulting document can be called a ‘record’ or collectively referred to as ‘documentation’. Cosmetic GMP emphasizes the importance of capturing all production processes and workflows in writing, whether that is in paper or electronically.

Not only should documentation exist to guide what must be done, records should also be created to capture what was done each time a specific batch is created. When issues arise, the maintenance of accurate records helps businesses quickly identify what went wrong and why. It also provides evidence that GMPs are being followed.

Cosmetic businesses may want to consider the following:

• Have you documented all of your production operations, processes, and practices?
• Do you create records or logs for all your production activities?
• Are you keeping appropriate and timely backups of your documentation?
• Do you create records of all ingredients or raw materials (such as their unique codes, quantities, and lot numbers) that get incorporated into each batch?
• Are your records sufficient to carry out a prompt recall of a product if needed once it is in distribution?

Buildings & Facilities

The operational premises of a cosmetic business should offer a clean, safe, hygienic environment that minimizes the risk of contamination. The facilities should be organized in a methodical way (e.g. there should be an adequate division of production, storage, and packing activities), and there should be appropriate cleaning, sanitization, and pest control protocols in place.

Cosmetic businesses may want to consider the following:

• Is your workspace organized in a way that prevents possible mix-ups or contamination?
• Are building equipment and facilities such as plumbing and heating working appropriately and maintained periodically?
• Is your workspace (including tables, floors, ceilings, and other surfaces) made of a material that can be readily cleaned and sanitized?
• Do you ensure that only authorized personnel enters your production facility?

Equipment Used

All equipment used, such as bowls, utensils, and measuring tools should be clean and prevent the adulteration of finished cosmetics with foreign material, dirt, or cleaning products. They should be stored properly and calibrated periodically if needed. If broken or no longer suitable for use, they should be fixed or replaced.

Cosmetic businesses may want to consider the following:

• Are you using equipment that is proper and suitable for its purpose?
• Are you using equipment that is clean and sanitary?
• Are your scales and other relevant equipment calibrated regularly?
• Is your equipment checked periodically to ensure they are working correctly?

Personnel

Cosmetic GMP highlights the importance of ensuring that employees are adequately trained, experienced, and qualified so that their behavior contributes to safety and quality rather than compromising it. They should also have the necessary backing from the company (in the form of training, supervision, education, resources, safety equipment, and so on) to perform their job appropriately and with cleanliness.

Cosmetic businesses may want to consider the following:

• Are you or your employees in charge of manufacturing and quality control well-trained to carry out their job tasks and responsibilities?
• Are you or your employees equipped with the materials/resources necessary to perform jobs safely and hygienically?
• Are you or your employees practicing good hygiene, for example, wearing a hairnet, protecting the workspace from open cuts or wounds, and practicing handwashing?
• Have you appointed a sufficient number of employees to supervise the overall (and aspects of) the production process?

Raw Materials

All raw materials should be organized and labeled with relevant identifiable information (name, lot number, and control status) so that they can be traced at any point in the manufacturing process. Additional guidelines are stated for water, color additives, and restricted cosmetic ingredients.

Cosmetic businesses may want to consider the following:

• Are your raw materials stored appropriately to prevent spoilage or deterioration?
• Are your raw materials labeled clearly and accurately?
• Do you have processes in place to verify that the water incorporated in your products is clean, hygienic, uncontaminated, and of a certain quality (e.g. distilled or deionized)?

Production Process

Appropriate documentation and records should be created to capture all aspects of the production process. The guideline recommends establishing Standard Operating Procedures (SOPs) for all processes. An SOP is simply a clearly written instructional document that clarifies in detail how a specific production activity is conducted.

Cosmetic businesses may want to consider the following:

• Is your production process outlined or mapped out in detail?
• Do you create records for each batch you produce, including details such as the formulation, raw materials, and equipment used, procedures followed, and a unique batch number?

Laboratory Controls

Cosmetic GMP emphasizes that testing should be conducted for raw materials, in-process samples, and finished product samples to see if they comply with relevant quality criteria and specifications. While complete laboratory testing may not be feasible for smaller cosmetic businesses, it is important to have protocols in place that allow raw materials and finished products to be regularly examined for issues such as contaminants or purity.

Cosmetic businesses may want to consider the following:

• Do you keep samples of received shipments and finished products so that they can be tested or observed again for compliance?
• Do you carry out testing to ensure the effectiveness of preservative systems used?

Internal Audit

The purpose of conducting an internal audit is to evaluate the overall performance of a quality management system. It should be able to identify the system’s strengths and weaknesses, as well as advise a plan of action to overcome failings in GMP. A good internal audit should be unbiased and strive towards continuous improvement through rigorous self-reflection.

Cosmetic businesses may want to consider the following:

• Do you have an internal audit plan or checklist that can accurately identify the current performance, strengths, and weaknesses of your GMPs?
• Does this plan include a follow-up that corroborates and records the improvements made as a result of the audit?

Complaints, Adverse Events, and Recalls

Any complaints or adverse events reported on a particular product should be recorded and evaluated thoroughly. This review process should be documented using Standard Operating Procedures (SOPs) and applied to both written and verbal complaints.

A systematic complaint logging and review process helps businesses hone in on the source of those events, in turn recognizing potential issues with safety or quality. For instance, a complaint regarding the odor or color of a product can flag a possible issue with spoilage or contamination. Similarly, a complaint about an incorrect label could signal a possible mix-up that could be affecting other products within a batch. Adverse events, which include complaints of undesired bodily reactions in response to the product, should be evaluated with extra care.

If a severe or high-risk safety or quality issue is suspected, a company may conduct a total product recall. Again, relevant documentation should be created to ensure there is a systematic plan of action that could lead to a swift and efficient product recall.

Cosmetic businesses may want to consider the following:

• Do you have SOPs in place for logging and reviewing of all complaints? Do these documents enable you to identify and take action against possible quality or safety issues?
• Do you have an SOP in place for product recalls? Does this document enable you to identify and execute a prompt recall of a specific batch once it is in distribution?

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REMEMBER: COSMETIC GMPs ARE MINIMUM STANDARDS

A final thought is that GMP recommendations are considered to be minimum standards, not an ultimate goal. Businesses should, therefore, aspire to exceed GMP standards and not just meet them.

It may also be useful to remember that GMP should be viewed as a valuable resource rather than a daunting rule book. By implementing its practices, businesses will be able to manufacture high-quality cosmetic products consistently and with confidence.

ADDITIONAL RESOURCES

The official websites of the FDA (Food and Drug Administration), Health Canada, ISO (International Organization for Standardization), and ICCR (International Cooperation on Cosmetics Regulation) can be consulted for up-to-date information and relevant guidance documents regarding cosmetic Good Manufacturing Practices.