What is GMP in cosmetics?September 1st, 2022 By Amber Benjamin
In this article, we will discuss:
- What is GMP?
- How does ISO 22716 conform to Good Manufacturing Practices?
- Is GMP required for cosmetics?
- What guidelines are included in GMP
- How GMP is assessed and rated against unconformities
- How you can earn an ISO 22716 certification
What is GMP?
Good Manufacturing Practices (GMP) are the actions required to conform to the guidelines set by agencies that control the authorisation, licensing, and sale of cosmetics, consumables, pharmaceutical products, dietary supplements, and medical devices.
The establishment of GMP ensures products manufactured are consistently developed at high-quality standards for their intended use. With a manufacturer abiding by these guidelines, GMP’s purpose is to help prevent harm to the consumer due to low-quality and high-risk products.
How does ISO 22716 conform to Good Manufacturing Practices?
The guidelines of Good Manufacturing Practices (GMP) mean that a business will have procedures to ensure that products are prepared in a sterile environment and do not become contaminated in production.
Many companies are automatically presumed compliant with the GMP regulation if they follow the guidelines set out by the International Standard Organisation (ISO), ISO22716. This is because ISO 22716 includes the policies needed to comply with GMP and further expands your compliancy according to the ISO standard.
Is GMP required for cosmetics?
As part of ISO 22716, every European market product must be manufactured and produced according to the Good Manufacturing Practices (GMP) under the European Union’s Regulation (EC) No 1223/2000. By implementing ISO 22716, compliance with GMP can be demonstrated.
Although following ISO 22716 is not a legal requirement, companies can use whatever GMP they wish. However, this would require them to demonstrate their system, which achieves the same objective as the ISO 22716 guidelines.
Having ISO 22716 ensures companies comply with all the recommended Cosmetics GMP guidelines in the production, control, storage, and shipment of cosmetic products. Conformance to Good Manufacturing Practices (GMP) ensures that your products are produced in a hygienic environment, which creates little to no risk or harm to the consumer.
The guidelines for Good Manufacturing Practices, according to the Food & Drug Administration (FDA) in the USA, are as follows:
- Building and Facilities: This section describes that the facility’s construction, design, and size must permit unobstructed equipment placement and sanitary operation. This includes installing and operating building structures that do not contaminate cosmetic materials.
- Equipment – This section outlines that equipment and utensils must be of appropriate design and material to prevent corrosion, dirt, or adulteration with lubricants. This section also details the storage and sanitisation of portable equipment.
- Personnel – This section describes that the person supervising or the individual performing the manufacturing must have the required training or experience to perform the assigned function with the control of cosmetics. This includes the appropriate outer garments and maintenance of adequate personal cleanliness.
- Raw Materials – This section describes that raw and primary packaging materials must be stored correctly to prevent mix-up contamination with microorganisms, chemicals, or decomposition from exposure to other substances. This section also includes sampling and testing materials.
- Production – This section describes that documented or written instructions must be supplied or maintained, with relevant filing, storing, or transferring instructions and methods. This section also details the procedures employees must adhere to comply with GMP.
- Laboratory Controls – This section describes the process of sampling, approval of batch and raw materials, and storage conditions cosmetics must undergo.
- Documentation and Recordkeeping – This section describes the documented disposition of rejected materials, finished products, distribution, shipment, code marks, and others.
- Labelling – The manufacturer must highlight the appropriate labelling of cosmetics, such as the product’s name, content, ingredients, and any warning statements.
- Complaints – The firm must maintain a consumer complaint file which records the severity of each reported injury or body part involved. This file must also include the product associated with each injury, the medical treatment, and the names and locations of any poison control centre government or physician group where the formula is provided.
- Other – Compliance within the firm can be assessed by staff to see if they participate in other voluntary registration programs.
The risk of adulterating chemicals or misbranding cosmetic packaging can be minimised by following the guidelines of GMP.
Due to the added benefit of GMP being part of the ISO 22716 standard, most businesses will find obtaining ISO 22716 highly beneficial as it goes above and beyond what is expected of a compliant business.
Further additions which ISO 22716 includes are:
- Personnel and training
- Production and manufacturing
- Raw materials and packaging
- Finished products
- Waste management
- Subcontract operations
- Quality control and sample retention
- Complaints and recall
- Change control
How is GMP assessed and rated against unconformities?
Agencies that regulate cosmetics, such as the FDA (Food and Drug Administration) in the US, are authorised to conduct unannounced GMP inspections, even though some are scheduled.
According to gov.uk, every manufacturer will receive a risk rating or score based on the assessment conducted for GMP. Those who have the highest ratings will be prioritised due to increased risks.
The unconformities found are based on:
- Your businesses compliance reports
- International information about the previous history of inspections your business has received
- Organisational and structural changes internally within the business
During inspections, a team will interview relevant personnel, review documents, and conduct site visits. The inspection team also has the right to ask for additional documentation and samples for testing.
Once the inspection is complete, the inspector will provide you with feedback and discuss an agreed timeframe for which corrective actions must be completed.
How can I achieve an ISO 22716 certification for my business?
If you are interested in ISO 22716 for your business, you can contact IMSM and schedule a free consultation to explore your next course of action in greater detail. At IMSM, we have a transparent fixed fee and flexible approach to make implementation efficient and straightforward.
We will then help you select the most appropriate Certification Body to provide you with your certification.
For a free Quotation or Remote presentation by an ISO Specialist, contact us today!
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