Development and Delphi validation of an instrument for the preparation of a GMP audit of a cosmetics subcontractor in the UAE
The establishment of the ISO 22716 GMP guidelines was an important step in the development of a global standard for the safety of cosmetics and personal care products. In particular, the standard focuses on the technical, human and administrative factors that can influence the quality of cosmetic products. In this context, the present study aimed to work towards a national consensus on the safety of cosmetic and personal care products by developing an audit preparation tool for cosmetic subcontractors. Similar GMP questionnaires have proven to be a useful aid in preparing for audits14, and many cosmetic manufacturers are already using such instruments. Nevertheless, until now, no study has investigated the use, content and validity of these GMP questionnaires.
The findings of this study demonstrate that the developed audit preparation instrument has reasonably good content validity. Almost all the quality items (47 out of 52; 90%) were considered essential by all the experts on the panel; the remaining 5 items did not meet the predefined criterion of at least 75% concordance. Based on these results, 5 items were deemed irrelevant to the instrument and were excluded. While the Delphi method conventionally offers a new set of Delphi questionnaires at this stage to further assess the agreement between experts19, this study stipulated the criterion that if the level of agreement was less than 75%, the particular element would be removed from the instrument. Therefore, no further rounds of Delphi questionnaires were conducted.
The first draft audit of the brainstorming session received some criticism from members of the scientific committee. Specifically, seven of the experts said that some of the questions were too detailed, while others felt that the yes/no format provided insufficient information. Therefore, these experts recommended using open-ended questions. Based on these comments, text fields at the end of each section were provided in the final audit instrument where the experts could clarify their responses during the Delphi cycle. However, in the early stages of the study, the case firm decided that the convenience of completing the audit preparation instrument was paramount, and so yes/no questions were primarily used in its development.
An in-depth knowledge base is necessary for the development of a GMP questionnaire29. However, the panel of experts consulted in the Delphi round was relatively small (n=50). Despite its small size, each panel member had experience in both GMP and the cosmetics industry, which gave them an in-depth perspective on the research context. In addition, the inclusion of experts from authorities and universities ensured the diversity of the panel. Finally, the Delphi questionnaire received a very good response rate of 71.4%. In previous research, Delphi cycles involved panels of experts ranging from 4 to 3000 people17while several studies using the Delphi method involved relatively small panels of experts18.21.
The building and facilities section of the audit tool ensures that product manufacturing and storage locations do not interfere with the quality of cosmetic products. The building and facilities section provides plant design and construction principles. It sets the sanitary conditions under which manufacturers must develop and store cosmetic products30. Through these principles, consumers can enjoy products that have undergone proper storage, proper cleaning, and protection from toxic surfaces and environments. At the same time, the section has principles guiding the environment in which workers operate. In addition, they emphasize sufficient water supply, proper sewage disposal, toilets, hand washing facilities and cleaning of garbage. In particular, the section guarantees that consumers use cosmetic products produced under hygienic conditions.
The equipment section of the audit tool contains principles that guide the care of utensils used in the manufacture, storage and distribution of cosmetic products. Specifically, the principles guide how manufacturers and distributors should manage any type of equipment in relation to the contamination of cosmetic products. He stresses that cosmetic products must be kept clean to avoid contaminating the products during manufacturing, storage and distribution.30. Therefore, consumers use products that are free of toxins and impurities from the equipment used.
The personnel section of the audit instrument involves every individual who handles cosmetic products at any level of production or distribution. This section states that cosmetics manufacturers must implement guidelines and programs that ensure disease control, cleanliness of all workers, proper education and training, and adequate supervision.30. Thus, consumers have access to products whose manufacture involves hygiene, know-how and close observation. Therefore, the personnel section of GMP is essential to ensure that those involved in manufacturing, storage and distribution respect the health and safety of consumers.
The raw materials section of the audit instrument has many provisions. First, raw materials must undergo inspection and be handled in a manner that ensures cleanliness31. Measurement improves a good start during the manufacturing process. Second, the raw materials should not contain microorganisms that cause disease in humans31. This guideline helps to protect consumers against the use of harmful cosmetic products. Third, materials containing potentially contaminated ingredients, such as aflatoxin, must comply with Drug Administration policies. This directive protects consumers against the use of products containing high levels of toxic chemicals. The final guideline is that raw materials should remain in storage facilities that protect them from contamination31. The directive guarantees the use of clean raw materials for manufacturing. All the policies ensure that the raw materials become finished products which are harmless to the organism of the consumers.
The Production section contains provisions that guide the conditions under which companies manufacture cosmetic products. Section emphasizes proper time, temperature, pH and acidification32. The section’s guidelines ensure that the production process of each product meets the recommended conditions. Consumers value products whose production involves the use of appropriate conditions.
The laboratory checks section involves testing the chemicals involved in the production of cosmetics to check the levels of each chemical in the ingredients. With this in mind, laboratory testing guidelines require components to undergo investigation, sampling, retesting if necessary, and thorough analysis of the results.33. The guidelines ensure that consumers use products that have been scientifically proven to be safe for humans.
The documentation section ensures the traceability of all development, manufacturing, testing and distribution activities34. The guidelines in this section ensure that whenever consumers need to ask questions about the manufacture of a product, the company will easily retrieve records showing its journey from development to sale.
The packaging and labeling section ensures that finished products are protected from contamination and mixing31. The main objective of this section is to protect the consumer against the use of cosmetic products containing toxins or mixed due to poor packaging and labeling.
Complaints section requires companies to register and investigate every complaint35. Complaints will prompt companies to recall or redefine the production of the affected cosmetic products. The section gives consumers a voice as it ensures that manufacturers meet their quality requirements.
Audit preparation instruments, such as the one developed here, have proven to offer considerable support during the contractor audit process. Current research will continue by examining how well a completed audit preparation instrument reflects reality during an audit. To do this, the answers provided by the company will be compared to the actual conditions observed during the audit. This comparison will offer valuable insights into the applicability and practicality of the preparation instrument that can be incorporated into future research. Additionally, collecting feedback from contractors on the process of making the instrument will also provide crucial information on its usefulness.
The results of the study offer guidance to cosmetics companies wishing to incorporate cosmetic GMPs when outsourcing their production to contract manufacturers, thereby ensuring consistency. Cosmetics companies operating outside the UAE may also find these results useful for the implementation of cosmetic GMPs, although these results primarily focus on the UAE context. However, the development and validation of an instrument as described in this study is only a fraction of what is needed to obtain a reliable and adequate instrument for application in its respective field – further studies are needed. to assess the psychometric properties of the instrument.