Development and Delphi validation of an instrument to prepare a GMP audit of a cosmetics contract manufacturer in the UAE

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The establishment of the GMP guide ISO 22716 was an important milestone in the development of a global standard for the safety of cosmetic and personal care products. In particular, the standard focuses on technical, human and administrative factors that can affect the quality of cosmetic products. Against this background, the current study aimed to work towards a national consensus on the safety of cosmetic and personal care products by developing a tool to prepare for the audit of cosmetic contract manufacturers. Similar GMP questionnaires have proven to be a useful aid in preparing for audits14, and numerous cosmetics manufacturers are already using such instruments. However, no study has yet examined the use, content and validity of these GMP questionnaires.

The results of the current study show that the test preparation tool developed has a fairly good content validity. Almost all quality aspects (47 out of 52; 90%) were rated as essential by all experts on the panel; the remaining 5 items did not meet the predefined criterion of at least 75% agreement. Based on these findings, 5 items were judged not relevant to the instrument and excluded. While the Delphi method traditionally proposes a new Delphi round of questionnaires at this point to perform an additional check of agreement among the experts19, this study defined the criterion that if the level of agreement is less than 75%, the respective item is removed from the instrument. Therefore, no further Delphi rounds of questionnaires were carried out.

The first draft of the exam in the brainstorming session was criticized by the members of the scientific committee. In particular, seven of the experts indicated that some of the questions were too detailed, while others felt that the yes/no format provided insufficient information. Therefore, these experts recommended the use of open-ended questions. Based on this feedback, text boxes were provided at the end of each section in the final audit tool, allowing the experts to clarify their answers in the Delphi round. However, in the early stages of the study, the case company decided that convenience in completing the audit preparation tool was of paramount importance and thus mainly yes/no questions were used in its development.

A thorough knowledge base is required to develop 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 the GMP and cosmetics industries, giving them deep insight into the context of the research. The inclusion of experts from authorities and universities also ensured the diversity of the panel. Finally, the Delphi questionnaire received a very good response rate of 71.4%. In earlier studies, expert panels of 4 to 3000 people were involved in Delphi rounds17while relatively small expert panels were involved in several studies using the Delphi method18:21.

The ‘Buildings and facilities’ section of the audit tool ensures that the sites where products are manufactured and stored do not affect the quality of cosmetic products. The Buildings and Facilities section contains facility design and construction principles. It specifies hygienic conditions under which manufacturers must develop and store cosmetic products30. These principles enable consumers to enjoy products that have been properly stored, properly cleaned and protected from toxic surfaces and environments. At the same time, the section contains principles that guide the environment in which employees work. In addition, they emphasize adequate water supply, proper sanitation, toilet facilities, hand washing facilities and garbage collection. In particular, the section ensures that consumers use cosmetic products that have been manufactured under hygienic conditions.

The Equipment section of the audit tool contains principles that guide the maintenance of utensils used in the manufacture, storage and distribution of cosmetic products. The principles guide exactly how manufacturers and distributors must deal with any type of equipment in relation to the contamination of cosmetic products. She emphasizes that cosmetic products must remain clean to avoid product contamination during manufacture, storage and distribution30. As a result, consumers use products that are free from toxins and contaminants derived from the equipment they use.

The human resources section of the audit tool includes all people who handle cosmetic products at any level of production or distribution. This section states that cosmetic manufacturers must implement policies and programs that ensure disease control, cleanliness among all workers, proper education and training, and proper surveillance30. This gives consumers access to products whose manufacture requires hygiene, know-how and close observation. Therefore, GMP’s human resources department is vital to ensure that those involved in manufacturing, storage and distribution respect the health and safety of consumers.

The Raw Materials section of the exam instrument contains numerous provisions. First, the raw materials must be inspected and handled in a way that ensures cleanliness31. The measure supports a clean start during the manufacturing process. Second, raw materials do not have to contain microorganisms that cause disease in humans31. This policy helps protect consumers from using harmful cosmetic products. Third, materials with contamination-prone ingredients, such as aflatoxin, must comply with drug agency guidelines. This policy protects consumers from using products with high levels of toxic chemicals. The final guideline is that raw materials must remain in storage facilities that protect them from contamination31. The policy ensures the use of clean raw materials for manufacturing. All guidelines ensure that the raw materials become end products that are safe for the consumer’s body.

The Production section contains provisions that regulate the conditions under which companies produce cosmetic products. The section emphasizes appropriate time, temperature, pH, and acidification32. The section guidelines ensure that the production process of each product conforms to the recommended conditions. Consumers enjoy products whose manufacture required the use of reasonable conditions.

The laboratory controls section involves testing the chemicals involved in the manufacture of cosmetic products to verify the levels of each chemical in the ingredients. With this in mind, laboratory control policies require that components be examined, sampled, retested if necessary, and thoroughly analyzed33. The guidelines ensure that consumers use products that have been scientifically proven to be safe for humans.

The documentation area ensures the traceability of all development, manufacturing, testing and sales activities34. The guidelines in this section ensure that whenever consumers need to ask how a product was made, the company can conveniently retrieve the records that describe the journey from development to sale.

The packaging and labeling area ensures that the end products are protected from contamination and mixing31. The main objective of the section is to protect the consumer from using cosmetic products that contain toxins or are confused due to poor packaging and incorrect labeling.

The Complaints section requires companies to record and review every complaint35. The complaints will prompt companies to recall or reschedule production of the affected cosmetic products. The section gives consumers a voice as it ensures manufacturers meet their quality standards.

Audit preparation tools such as the one developed here have proven to be essential support in the auditing of toll manufacturers. Current research continues by examining how well a completed exam preparation tool reflects reality during an exam. For this purpose, the company’s answers are compared with the actual statuses observed during the audit. This comparison will provide valuable information on the applicability and practicality of the dissection instrument, which can be incorporated into future research. In addition, gathering feedback from contract manufacturers on the process of finalizing the tool will also provide crucial information on its usefulness.

The study results provide guidance for cosmetics companies looking to incorporate cosmetics GMP when outsourcing their production to contract manufacturers to ensure consistency. Cosmetics companies operating outside the UAE might also find these results useful for the implementation of cosmetics GMP, although these results mainly focus on the UAE context. However, the elaboration and validation of an instrument as described in this study is only a fraction of what is required to obtain a reliable and adequate instrument for use in its particular field – further studies are needed to establish the psychometric evaluate the properties of the instrument.

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