The establishment of the ISO 22716 GMP guidelines was a significant milestone in the development of a worldwide standard for the safety of cosmetics and personal care products. In particular, the standard focuses on technical, human, and administrative factors that can influence the quality of cosmetic products. Against this backdrop, the current study aimed to work towards a national consensus on cosmetics and personal care product safety by developing an instrument to prepare for cosmetic contract manufacturer auditing. Similar GMP questionnaires have been shown to be a useful aid in preparing for audits14, and numerous cosmetics manufacturers already employ such instruments. Nonetheless, thus far no study has investigated the use, contents, and validity of these GMP questionnaires.
The findings of the current study demonstrate that the developed audit preparation instrument has reasonably good content validity. Nearly all the quality items (47 of 52; 90%) were rated as essential by all the experts on the panel; the remaining 5 items did not meet the pre-defined criterion of at least 75% agreement. Based on these findings, 5 items were judged not relevant to the instrument and were excluded. While the Delphi method conventionally suggests a new Delphi questionnaire round at this point to conduct an additional assessment of agreement among the experts19, this study stipulated the criterion that if the agreement level was found to be below 75%, the particular item would be removed from the instrument. Hence, no further Delphi questionnaire rounds were performed.
The first draft audit in the brainstorming session received some criticism from the members of the scientific committee. Specifically, seven of the experts said there was too much detail in some of the questions, while others felt that the yes/no format provided insufficient information. Hence, these experts recommended using open-ended questions. Based on this feedback, text fields located at the end of each section was provided in the final audit instrument where the experts could clarify their responses in the Delphi round. However, in the early stages of the study, the case company decided that convenience in completing the audit preparation instrument was paramount, and thus yes/no questions were mostly used in its development.
A thorough knowledge base is necessary for the development of a GMP questionnaire29. However, the expert panel consulted in the Delphi round was relatively small (n = 50). Despite its small size, each panel member had experience in both GMP and the cosmetic industry, which gave them an in-depth perspective on the context of the research. Further, the inclusion of experts from the authorities and universities ensured the diversity of the panel. Finally, the Delphi questionnaire round received a very good response rate of 71.4%. In prior research, Delphi rounds involved expert panels ranging from 4 to 3000 individuals17, while several studies using the Delphi method involved relatively small expert panels18,21.
Building and Facilities section of the audit instrument ensures that the locations where products are manufactured and stored do not interfere with the quality of cosmetic products. The building and facilities section provides plant design and construction principles. It sets sanitary conditions under which manufacturers need to develop and store cosmetic products30. Through these principles, consumers can enjoy products that have undergone proper storage, adequate cleaning, and protection from toxic surfaces and environments. At the same time, the section has principles guiding the environment in which workers operate. Further, they emphasize ample water supply, proper sewage disposal, toilet facilities, hand-washing amenities, and rubbish clearance. Notably, the section ensures that consumers use cosmetic products manufactured under hygienic conditions.
The equipment section of audit instrument contains principles that guide the maintenance of utensils used in manufacturing, storing, and distributing cosmetic products. Precisely, the principles guide how manufacturers and distributors need to handle any type of equipment in relation to the contamination of cosmetic products. It emphasizes that cosmetic products need to stay clean to avoid contaminating products during manufacturing, storage, and distribution30. Therefore, consumers use products that are free from toxins and impurities originating from equipment used.
The personnel section of audit instrument involves every individual who handles cosmetic products at any level of production or distribution. This section stipulates that cosmetic manufacturers need to implement guidelines and programs that ensure disease control, cleanliness among all workers, proper education and training, and adequate supervision30. That way, consumers access products whose manufacture involves hygiene, expertise, and keen observation. Therefore, the personnel section of GMP is essential in ensuring those involved in the manufacture, storage, and distribution respect the health and safety of consumers.
Raw Materials section of audit instrument have numerous provisions. First, raw materials need to undergo inspection and be handled in a manner that ensures cleanliness31. The measure enhances a clean start during the manufacturing process. Second, raw materials need not contain microorganisms that cause disease in humans31. This guideline helps to protect consumers from using harmful cosmetic products. Third, materials with ingredients that are susceptible to contamination, such as aflatoxin, need to comply with the Drug Administration policies. This guideline protects consumers from using products with high levels of toxic chemicals. The final guideline is that raw materials need to stay in storage facilities that protect them from contamination31. The guideline ensures the use of clean raw materials for manufacturing. All the policies ensure that the raw materials become end-products that are safe for consumers’ bodies.
Production section has provisions that guide the conditions under which companies manufacture cosmetic products. The section emphasizes the appropriate time, temperature, pH, and acidification32. The section guidelines ensure that each product’s production process follows the recommended conditions. Consumers enjoy products whose production entailed the use of appropriate conditions.
Laboratory controls section involve testing the chemicals involved in the production of cosmetic products to check the levels of each chemical in the ingredients. With that in mind, laboratory control guidelines demand that components undergo investigation, sampling, retesting if needed, and thorough results analysis33. The guidelines ensure that consumers use products that are scientifically proven to be safe for human use.
Documentation section ensures traceability of all development, manufacturing, testing, and distribution activities34. The guidelines in this section ensure that whenever consumers need to ask about the manufacture of a product, the company will conveniently retrieve the records indicating its journey from development to sale.
The packaging and labeling section ensures that end-products are protected from contamination and mixing31. The main aim of the section is to protect the consumer from using cosmetic products that have toxins or are mixed up due to poor packaging and wrong labeling.
Complaints section demands that companies need to record and review each complaint35. The complaints will prompt the companies to recall or re-strategize the production of the involved cosmetic products. The section gives a voice to consumers since it ensures that manufacturers meet their quality demands.
Audit preparation instruments, such as the one developed here, have been shown to offer considerable support during the contract manufacturer auditing process. The current research will continue by investigating how well a completed audit preparation instrument reflects the reality during an audit. To achieve this, the answers provided by the company will be compared to the actual conditions observed while auditing. This comparison will offer valuable information on the applicability and practicality of the preparation instrument that can be integrated into future research. Furthermore, gathering feedback from contract manufacturers on the process of completing the instrument will also give crucial information on its usefulness.
The study results offer guidance for cosmetic companies aiming to incorporate cosmetics GMP when outsourcing their production to contract manufacturers, thereby ensuring consistency. Cosmetic companies operating outside the UAE may also find these results useful for implementing cosmetics GMP, although these findings primarily focus on the UAE context. However, elaboration and validation of an instrument such as described in this study is only a fraction of what it takes to obtaining a reliable and adequate instrument to be applied in its respective field—further studies are necessary to assess the psychometric properties of the instrument.
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