Good Manufacturing Practices

You want to set up as a cosmetic manufacturer and you would like to know more about the requirements ? Whether you are developing your cosmetics from A to Z or marketing your cosmetic products by outsourcing manufacturing, it is necessary to comply, among other things, with the Good Manufacturing Practices (GMPs).

Let’s see together what this means, and what are the resulting requirements and how to implement them within your structure.

What are the Good cosmetic Manufacturing Practices ?

The good cosmetic manufacturing practices, detailed in the ISO 22716 standard, are a set of measures, processes et organizational means that must be respected in order to be able to market a cosmetic within the European Union. They include a set of recommandations to ensure the product compliance for the consumer, they also detail how to assess he risks associated with the manufacture, the control, the storage and the shipment of products.

● Objectives of this standard :

Globally, the respect of the good cosmetic manufacturing practices aims to comply with the company’s management system to the requirements of European cosmetic regulations, and it aims to guarantee access to the European market.

More concretely, these practices aim to help companies in the organization of their laboratory, in their layout, in their personnel’s training, as well as in the monitoring of raw materials and finished products. The ultimate goal is to ensure the consumer’s safety and to guarantee the products’ quality.

● Who are the good cosmetic manufacturing practices intended for ?

Good cosmetic manufacturing practices concern all the other actors involved in the production, control, storage and shipping of cosmetic products such as the manufacturers of finished products, distributors or importers/exporters. Moreover, this standard has been written for big structures as well as for micro-companies, the standard is adaptable and applicable to all scales.

● Why are they necessary ?

The cosmetic products’ compliance to the good manufacturing practices is imposed by Regulation EC 1223/2009. Indeed, it is specified in Article 8 of this regulation :

« The manufacture of cosmetic products shall comply with good manufacturing practices in order to guarantee the objectives of Article 1. Compliance with good manufacturing practices shall be presumed when manufacturing is carried out in accordance with the applicable harmonized standards whose references have been published in the Official Journal of the European Union.»

The Cosmetic Regulation 1223/2009 also indicates in Article 11 that a declaration of compliance with the ISO 22716 standard needs to be added to the Product Information File (PIF) of your cosmetics for every marketed product. Finally, this regulation also reminds of the obligations of the Responsible Person regarding the compliance and the implementation of corrective actions relatively to GMPs.

Requirements of the ISO 22716 standard :

Here is a recap of different points of the ISO 22716 standard which describe the measures to take in order to comply with Good Manufacturing Practices :

Good Manufacturing Practices

Notes : The ISO 22716 standard is said to be « opposable », which means that there is no obligation to purchase or certification but that however the GMPs of a cosmetic product must be applied in a mandatory manner. We still recommend you to have access to the entire standard in order to be aware of all its requirements. (It is available on the ISO website for mourned 100-150 euros.)

● The staff First of all, the standard asks to appoint a quality responsible person for quality, yourself or a member of the staff. Then, each person needs to know his position, remember the tasks assigned to him and to be properly trained. Finally, each member of the staff must be formed with the GMPs, so they can guarantee both quality and safety of the products manufactured. As a reminder, hygiene rules are strict and essential in order to limit the rest of product contamination. People with access to the laboratory must be clean and wear protective clothing : lab coat, cap, lab shoes… They must also remember to frequently apply the hygiene procedures in place, such as regular hand washing.

● The locals This part of the standard is essential because this is here that the majority of the application good manufacturing practices takes place ! To summarize the requirements of the standard, it is necessary to : - Establish a space dedicated to the cosmetics’ manufacturing (laboratory, workshop…),

- The production area needs to be easily and frequently cleaned, disinfected and maintained. A ventilation system must be set up (the room must be able to be aired if needed). - The stocks of raw materials and finished products must be properly organized and stored in a dedicated space, different from the production area if possible (in order to limit the risks of mixing products/raw materials…), - The flow of products and personnel needs to be defined and respected (in order to avoid the risk of contamination as much as possible). ● Equipments As for the local, particular attention must be paid to the cleanliness of the equipment used. The different utensils and machines must be easy to clean, resist to corrosion and disinfectants. It is recommended to use stainless steel material (because it is easier to disinfect and it is less porous). Packaging items such as jars, bottles… must be kept in a clean and dry space. They also must be easy to access and not increase the contamination risks (especially when transporting from one space to another). Finally, regular calibrations of measuring tools, weighers…must be carried out in order to ensure and guarantee the composition of manufactured products and not to harm the safety of the consumer.

● Raw materials and packaging items The choice of raw materials and packaging items is essential for the compliance with GMPs. It will therefore be necessary to ensure that suppliers are rigorously selected and that they are able to provide every mandatory information and document. Upon receipt, it will be necessary to check, among other things, the order from the delivery note, the packaging’s condition, the batch numbers… The raw materials also need to be checked and compared with the analysis certificate provided by the supplier (visual, space, colors, smells…). All documents and informations must be kept in order to guarantee the traceability of the product. Once received, the items (raw materials and packaging items) must be stored in a dedicated space (clean and dry), in closed containers and not placed on the floor. Finally, manufacturing cosmetics require large quantities of water, it will be necessary to be able to guarantee its quality by carrying out analyses and setting up an adequate treatment system.

● The production For each production cycle, it will be needed to create a batch file in which will appear every following informations : ★ The product's formula, ★ The list of raw materials with the exact quantity used, the batch number, the expiry date, ★ The materials used (numbers and names of machines), ★ The operating mode detailing each step (different phases, temperatures, mixing speed…), ★ The batch number assigned to the production cycle in question.. You will also need to : - Check before each production cycle, cleanliness, safety and calibration of the premises and equipment - Identify the quality control points (ex : in step 3 the pH must be equal to 4.5) - Correctly label each finished product (mentioning the batch number) in order to limit the risk of error and guarantee a good traceability

● Finished products Once the product has been packaged and correctly labelled, it must be stored in the space provided for this purpose. Careful, the quality of the product must be ensured during all stages of storage, transport, shipping and return of the products (if necessary). Careful : strict storage rules must be put in place in order to easily differentiate the different batches, product returns and products placed in quarantine. As a reminder, the following informations must appear on the packaging : - The batch number, - Sell-by date, - The amount, - The INCI list, - Allergens.

● Treatment of out-of specification products and deviations It may happen that a quality control shows that a raw material, a batch or a packaging item is not good (product out of specification). Depending on the case, it will be necessary to manage this « non-conformity » and determine the different actions to be taken : destroy or reprocess the raw material or the finished product, return the product to the upper or manufacturer (in case of subcontracting) or refuse the receipt of the product. If a deviation or a variation is observed at a control point (during production) it will be necessary to report and justify it (in order to guarantee good traceability). Then in second step, it will be necessary to determine if this deviation impacts the product’s quality and its safety use. If this is the case, a decision must be made concerning the marketing of the impacted finished products and corrective measures will have to be put in place to prevent this discrepancy from recurring.

● Waste Production means waste ! Indeed, it will be necessary to anticipate and define the different types of waste that can be generated by the production and control processes. For each type of waste it will be necessary to determine the treatment methods so as to comply with the environmental regulations in force. Careful : the waste streams must in no way impede the safety and hygiene of the production and control processes. It will therefore be necessary to ensure that this flow is managed completely independently, in order to guarantee the quality of your product. ● Outsourcing Just like the choice of suppliers, the choice of subcontractors must be made rigorously. A contract or agreement with the subcontractor must be drawn up in order to explicitly define the requirements to meet the acceptance criteria with respect to the specificity of the cosmetic products manufactured. Remark : It is imperative to check that the subcontractors respect and work in accordance with de GMPs, since it is your responsibility that will be engaged if a problem occurs and that these points have not been checked upstream. ● Complaints and recalls In case of complaints, you must imperatively : - Check all the batches concerned - Check all the batches concerned Concerning the recalls, trials must be able to be implemented quickly in order to limit the risk of impact on consumer safety. In case of serious risks, the competent authorities (in France this is the ANSM) must be informed, and the products concerned must be easily and quickly identified. Recalled or received products must be stored separately pending the decision on the procedure to follow (destruction or other). Remark : in case of outsourcing, this point must be addressed when drawing up the contract as well. You will be required to check that a batch recall procedure is put in place by the subcontractor if necessary. ● Change management In case of modification of the operating mode, batch coding…the modifications must be approved by a qualified person and recorded. Old documents, for their part, must be archived in order to guarantee good traceability.

● Internal audits and quality department In order to guarantee and ensure the application of GMPs, internal audits must be carried out. During these audits it will be necessary to ensure that the various points of the ISO 22716 standard are respected and that non-conformities are correctly managed, the ultimate goal being to ensure consumer safety. ● Documentation Traceability being a particularly important and critical point, care must be taken to keep all your documentations (in digital or paper form), in particular supplier documents, batch files, PIFs, audits, subcontracts… all these documents must be updated if necessary and all previous versions must be kept. They must also be dated signed and accessible in case of control by the authorities. Would you like to know more about Good Cosmetic Manufacturing Practices ? Or would you like to be accompanied in your steps ? Don’t hesitate to contact us, we would be happy to help you !