本實驗室接受PIF化粧品產品資訊檔案(Cosmetic Product Information File (PIF))委託。
PIF應以中文或英文建立下述資料:
# | 項目 |
---|---|
1 | 產品基本資料:產品名稱、產品類別、劑型、用途、製造廠名稱與地址及產品製造或輸入業者資訊。 |
2 | 完成產品登錄之證明文件。 |
3 | 全成分名稱及其各別含量。 |
4 | 產品標籤、仿單、外包裝或容器。 |
5 | 製造場所符合化粧品優良製造準則之證明文件或聲明書。 |
6 | 製造方法、流程。 |
7 | 使用方法、部位、用量、頻率及族群。 |
8 | 產品使用不良反應資料。 |
9 | 產品及各別成分之物理及化學特性。 |
10 | 成分之毒理資料。 |
11 | 產品安定性試驗報告。 |
12 | 微生物檢測報告。 |
13 | 防腐效能試驗報告。 |
14 | 功能評估佐證資料。 |
15 | 與產品接觸之包裝材質資料。 |
16 | 產品安全資料: 安全資料簽署人員 (SA) (Safety Assessor) 簽名 |
# | ITEM |
---|---|
1 | Product Basic information: product name, product category, dosage form, function, names and addresses of manufacturing production, importer information |
2 | Cos FDA registration |
3 | Product name and ingredients list |
4 | Outer package product labels, containers, and inserts |
5 | Valid GMP Certificate |
6 | Manufacturing methods and procedures |
7 | Usage: what parts of the body, frequencies, dosage, and targeted population |
8 | Adverse effects of the product application |
9 | Physical and chemical characteristics of the products and individual ingredients |
10 | Toxicological data of the ingredients |
11 | Product stability test reports |
12 | Microbiological test reports |
13 | Antimicrobial effectiveness test reports |
14 | Supporting information of the functional assessments |
15 | Information on packaging materials that come in contact with the products |
16 | Product safety information: Safety Assessment Conclusion and Suggestions (SA) (Safety Assessor) Signature |