Chapter 16 Documentation
Article 78
The cosmetics manufacturer shall design, establish, install and maintain its own documentation systems according to its organization structure and the type of the products.
The documentation systems mentioned in the preceding paragraph is an internal part of Good Manufacturer Practices. The documentation shall record all the operation activities according to these regulations to prevent risks of misinterpretation, loss of information, confusions or error.
Electronic systems may be established and managed documents mentioned in the documentation systems in Paragraph 1.
Article 79
The content of documentation systems mentioned in the preceding article shall include: procedures, instructions, specifications, protocols, reports, methods, and records.
The content of the documentation mentioned in the preceding paragraph shall be kept in hard-copy papers or electronic data processing records.
Article 80
All activities in these regulations such as operation details, measures to be taken, and precautions to be taken shall be detailed documented. The title, nature and purpose shall be stated in every document.
Documents mentioned in the preceding paragraph shall be written legibly and comprehensively. The authorized responsible personnel shall sign and indicate the date as approval before the announcement, and update, annul, distribute, and archive accordingly.
The documents mentioned in Paragraph 1 shall be obtained from the appropriate personnel in the company, and to ensure the annulled documents are deleted, destroyed and not being used again.
Article 81
The required hand written records in the documentation mentioned in Paragraph 1 Article 79 shall be regulated to write legibly with permanent ink. The recorder shall sign and indicated the date of the record. Any correction shall require the same consent.
The correction of the written records mentioned in the preceding paragraph shall leave the original entry readable, if necessary, the reason of the correction shall be recorded.
Article 82
The documents shall be updated if necessary. For those are updated, shall indicate the revision number and the reasons for each revision shall be retained.
Article 83
Archiving of the documentation shall be regulated as follows:
1. The controlled copies each revision of the documents mentioned in the preceding articles shall be used, and the original records shall be archived.
2. The duration of archiving original documents shall be defined according to the related regulations.
3. The storage of original documents shall be properly secured.
4. The documents shall be stored electronically or as hard-copy papers, and to ensure their legibility.
5. The documents shall be back-upped regularly and stored in a separated safe location.