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 Good Manufacturing Practices (GMP) ensures products manufactured are consistently developed at high-quality standards for their intended use. With a manufacturer abiding by these guidelines, Good Manufacturing Practices (GMP) purpose is to help prevent harm to the consumer due to low-quality and high-risk products.
How does ISO 22716 conform to GMP?
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 compliant with the Good Manufacturing Practices (GMP) regulation if they follow the guidelines set out by the International Organization for Standardization (ISO) in ISO 22716. This is because ISO 22716 includes the policies needed to comply with Good Manufacturing Practices (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 1223/2009. By implementing ISO 22716, compliance with Good Manufacturing Practices (GMP) can be demonstrated.
Although following ISO 22716 is not a legal requirement, companies can use whatever Good Manufacturing Practices (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 certification ensures companies comply with all the recommended cosmetics Good Manufacturing Practices (GMP) 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 GMP, according to the FDA
- 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 in order to comply with Good Manufacturing Practices (GMP).
- Laboratory controls: This section describes the process of sampling, approval of batch and raw materials, and storage conditions cosmetics must undergo.
- Documentation and record keeping: 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 products 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 programmes.
The risk of adulterating chemicals or misbranding cosmetic packaging can be minimised by following the Good Manufacturing Practices (GMP) guidelines.
Due to the added benefit of Good Manufacturing Practices (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 to ISO 22716
- Personnel and training
- Equipment
- Premises
- Production and manufacturing
- Raw materials and packaging
- Finished products
- Waste management
- Subcontract operations
- Deviations
- Quality control and sample retention
- Complaints and recall
- Change control
- Documentation
How is GMP assessed against unconformities?
Agencies that regulate cosmetics, such as the FDA (Food and Drug Administration) in the US, are authorised to conduct unannounced Good Manufacturing Practices (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 Good Manufacturing Practices (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 time frame for which corrective actions much be completed.
How can I achieve certification for my business?
If you are interested in ISO 22716 certification 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.
