Understanding and Implementing the Requirements of the ISO 22716 Good Manufacturing Practices Certification Standard for Cosmetic Products: The Components of ISO 22716
For the tenth part of this series of articles, QSE Academy now presents the components of ISO 22716.
To give you a recap, ISO 22716 delivers production, control, storage, and shipment quality guidelines for safe cosmetic products.
Furthermore, ISO 22715 covers all facets of the supply chain of cosmetic products. It involves early delivery of raw materials and components, as well as shipment of the final product to the customer.
The guidelines support organisations that want to follow advice to manage their human, administrative, technical sections, which are all impacting product quality.
Good Manufacturing Practices follow the sound scientific judgement principles and risk assessment to produce products that fulfill defined characteristics.
ISO 22716 Scope
ISO 22716 gives guidelines for the quality and safety aspects of cosmetic products.
As a result, suppliers of cosmetic ingredients and manufacturers of cosmetic final products are affected.
Likewise, the standard is significant for wholesalers, retailers, and brand holders of cosmetic products determined to boost the quality performance of their third-party suppliers.
Additionally, it identifies the general requirements for quality management systems by integrating a risk assessment based approach. This is to define critical and non-critical elements. Hence, guaranteeing high quality supply chain operations.
The ISO 22716 terms and definitions section is comprised of 36 definitions that are specific to their application.
This aims to reach and preserve consistency. Also, to encourage the use of common terminology.
The rationale behind the definition section gives clearness of terminology and stimulate the use of a common language.
CORE ELEMENTS OF ISO 22716:
The Cosmetics Quality Management System and Organisation
The cosmetics GMP quality management organisation focuses on creating and sustaining a qualified personnel base. This well-trained personnel base should be capable of unfailingly manufacturing safe products.
A sound knowledge personnel base in a cosmetics manufacturing organisation is of paramount significance. Similarly, this area is getting serious attention to quality guidance.
- A clear description of the tasks and responsibilities of all personnel.
- Developing operational internal and external communication channels to guarantee the commitment and participation of personnel.
Note that a controlled documentation system is a fundamental part of organisations working under ISO 22716.
Thus, all aspects of the quality organisation must be recognised in formal writing.
Premises and Equipment
ISO 22716 well describes another key element—proper design of areas for manufacturing, quality control, and storage.
This ensures all areas are fit for their purpose, and work accordingly for proper access and flow of materials.
It is crucial to establish a clear separation of manufacturing and storage activities, cleaning, and sanitisation to prevent any contamination and mix-ups.
An organisation must conduct scheduled maintenance of premises and equipment, as well as frequent calibration of monitoring devices. This aims to ensure tasks are performed as per defined and pre-set parameters of manufacturing, packaging, and storage.
The organisation’s quality unit must be involved to approve and analyse all changes. An objective overview of results obtained is also needed.
Product Realisation and Materials Management
An organisation working under ISO 22716 must set criteria for quality during various manufacturing stages. This includes specifications for purchased raw materials and packaging materials.
It must form the criteria for:
- In-process checks and parameters of starting materials;
- Intermediates or cosmetic ingredients;
- Finished products.
It is crucial for an organisation to follow these characteristics. In addition, there must be a clear description of the quality status of these materials during the entire supply chain of operations.
The Quality Unit must be fully integrated into an organisation’s operational activities. It helps the unit accomplish responsibilities such as applying changes in the quality status of starting materials and intermediate products.
Likewise, it is vital that contractors, as well as third-party transporters and packaging units, are involved in the quality efforts.
Deviations, Complaints, and Recalls
Deviations may happen internally and externally. For example, during transportation to a customer organisation.
Therefore, an organisation must have a system that will deal with deviations in the supply chain of operations.
Customer organisations must have the capacity to raise complaints, whenever necessary.
On the other hand, an organisation working under an ISO 22716 quality regime must probe these complaints. Also, an acceptable solution should be relayed to the customer.
Similarly, an organisation must coordinate a recall of products if a deviation is leading to a serious threat to health and safety.
Good Manufacturing Practices is a quality system that uses state-of-the-art organisational aspects significant for the cosmetics industry.
Therefore, organisations must be mindful of the current practices in their field. This includes aiming for constant quality improvement in their operations and throughout their supply chain.
This can be accomplished using an auditing process. An internal audit document, evaluates, resolves, and prevents non-conformities.
An optimal auditing system is a basis for an effective Corrective Action / Preventive Action (CAPA) planning.
- Create and document independence of the quality unit from the manufacturing and operations unit.
An organisation’s quality unit must be independent from the manufacturing and operations unit in making decisions.
This can be determined through an organisational chart wherein both the operations/manufacturing units and the quality unit report to the site’s senior management.
Thus, the senior management must sign and date the unique organizational chart.
These aspects must also be properly noted:
- Respective managers must sign and publish individual job descriptions of the Head of Manufacturing/Operations and Head of Quality.
- The job description of the Head of Quality must encompass distinct references to the responsibilities and authority of quality issues:
– release product;
– move product to a different quality status;
– deviation and investigation;
– change control;
– internal audit among other responsibilities.
- Do not exclusively base on commercial terms the criteria for the selection of suppliers of components, raw materials, and packaging materials.
Under a GMP regime, the selection of suppliers must be accomplished following an organisation’s written and approved procedures. This is also after pre-defined quality guidance.
Moreover, a once approved supplier cannot change on financial terms, yet requires to go through a similar qualification.
It is necessary for an organisation to have a written, controlled, and quality-approved list of suppliers and vendors.
- Define the responsibilities of all personnel for quality and manufacturing.
The organisation’s management should support and boost the qualification for GMP.
Generally, this is done by setting quality KPIs that are recurrently revised and updated.
Note that management review is an occurring activity in GMP compliant facilities.
- Demonstration of the commitment from management that they are serious in improving the organisation’s quality behavior.
- Clear identification of responsibilities for all personnel, including job descriptions.
- Encouragement of personnel to report abnormalities from normal processing.
- Organise appropriate assessment and audits of suppliers and sub-contractors.
An organisation working under GMP following ISO 22716 should have a sub-contractor or vendor qualification programme.
This qualification process includes a sub-contractor or a vendor’s initial qualification to collect a list of approved vendors and sub-contractors.
It requires an organisation to re-assess their sub-contractors and vendors.
Based on risk assessment, this can lead to performing regular audits or remote controls of third parties.
Lastly, the organisation working under ISO 22716 needs to present an apt risk-based approach for its third-party qualification programme.
- Define and write down the method of re-processing.
When a regular and distinct system does not produce the projected outcome, organisations may conduct re-processing.
Re-processing may cover manufacturing, storage, packaging, and transportation. However, predefined and pre-established steps must follow it.
For instance, an organisation working under ISO 22716 must define the suitable steps to take before applying for re-processing.
Thus, the organisation has to establish benchmarks for when to allow re-processing.
Last but not least, pre-defined and pre-established steps must be outlined in controlled and documented procedures. Also, the actual re-processing steps must be followed in Batch Manufacturing Records.
The components of ISO 22716 seem overwhelming. In reality, this can be simplified through toolkits specifically designed to accomplish every core element.
Hence, QSE Academy created a series of articles you can review to understand ISO 22716. We’ve also developed packages and trained ISO consultants to help you accomplish quality guidelines for safe cosmetic products.