PIF Guidelines on how to create and store files

1. Product Information File or
PIF

2. Requirements for Industry
The Company or Person placing a cosmetic
product in the market shall:
– Notify the regulatory authorities before the product is
put in the market (article 1-3)
– Ensure that they will not cause damage to human
health under normal or reasonably foreseeable
conditions of use (article 3)
– Keep the product information file readily accessible to
the regulatory authorities (article 8)
– Must have adequate knowledge or experience (article
8-d)

3. PIF
• Must be at the address of the Company
responsible for placing the product in the market
(as specified on the label): manufacturer,
importer or distributor
• PIF must be in the local language or English
• Must be “readily accessible”. What does that
mean? 1 day, 1 week? Depends if the audit is
unannounced or not
• Must be kept updated of all modifications

4. PIF
1. Qualitative and quantitative composition of the
product: name and percentage of ingredients
(for perfumes name of supplier, code of
perfume and percentage)
2. Specifications of the raw materials and finished
product (physico-chemical and microbiological)
3. Manufacturing method complying with ASEAN
GMP Guidelines
4. Assessment of the safety for human health of
the finished product, its ingredients, its
chemical structure and its level of exposure

5. PIF
5. Existing data on undesirable effects on human
health resulting form the use of the product
6. Supporting data for claimed benefits (efficacy
assessment)
7. Available methods used to check the
ingredients corresponding with the certificate
of analysis (Article 9)
8. Criteria used for microbiological control;
chemical purity of ingredients and/or methods
for checking compliance with those criteria

6. PIF
1. Qualitative and quantitative composition of the
product: name and percentage of ingredients
(for perfumes name of supplier, code of
perfume and percentage)
2. Specifications of the raw materials and finished
product (physico-chemical and microbiological)
3. Manufacturing method complying with ASEAN
GMP Guidelines
4. Assessment of the safety for human health of
the finished product, its ingredients, its
chemical structure and its level of exposure

7. Example
Raw
Material
code
Supplier INCI name Trade
Name
Function Conc
(% w/w)
1. abcd Company 1
Company 2
Company 3
Acrylic acid xxxx Film former 0.50%
2. efgh Company 4 Monoethanolam
ine
yyyy pH adjuster 0.50%
3. ijkl Company 5 Propylene
Glycol
zzzz Solvant 2.00%
4. In-house Water Solvant 90.00%
5. mnop Company 6 45100 wwww Colorant 0.20%
6. qrst Company 7 perfume A1234 Fragrance 0.30%
7. etc. Qsp.
100%

8. PIF
1. Qualitative and quantitative composition of the
product: name and percentage of ingredients
(for perfumes name of supplier, code of
perfume and percentage)
2. Specifications of the raw materials and finished
product (physico-chemical and microbiological)
3. Manufacturing method complying with ASEAN
GMP Guidelines
4. Assessment of the safety for human health of
the finished product, its ingredients, its
chemical structure and its level of exposure

9. Raw Material Specification
• Physico Chemical:
• Colour
• Odour
• Appearance
• IR Spectrum
• Refractive index
• Saponification index
• Heavy Metals content
• Microbiological:
• Bacteria
• Fungi and Yeast
Obtained from supplier
Methods must be available
Manufacturer must check compliance

10. Raw Material Specification
Special attention should be taken to:
• Water
• Impurities
• Interactions between impurities
• RM manufacturing process
• GMP of supplier
• Ingredients of natural origin:
– Which plant-animal
– Which part is used
– Consistency of supply

11. Finished Product Specification
• Physico Chemical:
• Colour
• Odour
• Appearance
• pH
• Water content
• Viscosity
• Microbiological:
• Bacteria
• Fungus & Yeast
• Stability
Developed by manufacturer
Must be relevant
Must have the test methods
Must check compliance

12. PIF
1. Qualitative and quantitative composition of the
product: name and percentage of ingredients
(for perfumes name of supplier, code of
perfume and percentage)
2. Specifications of the raw materials and finished
product (physico-chemical and microbiological)
3. Manufacturing method complying with ASEAN
GMP Guidelines
4. Assessment of the safety for human health of
the finished product, its ingredients, its
chemical structure and its level of exposure

13. Manufacturing Method
• Pre-mix ingredients 1 to 5 in a SS tank
and bring to 70°C while mixing
• In a secondary SS tank mix ingredients 6
to 8 and bring to 70°C
• Mix contents of tank 2 into tank 1 while
stirring at high speed for 30 min.
• Cool to 40°C stirring gently and add
perfume. Mix for 15 min.

14. PIF
1. Qualitative and quantitative composition of the
product: name and percentage of ingredients
(for perfumes name of supplier, code of
perfume and percentage)
2. Specifications of the raw materials and finished
product (physico-chemical and microbiological)
3. Manufacturing method complying with ASEAN
GMP Guidelines
4. Assessment of the safety for human health of
the finished product, its ingredients, its
chemical structure and its level of exposure

15. Article 3 ASEAN Cosmetic Directive
A cosmetic product placed on the market must not
cause damage to human health when applied
under normal or reasonably foreseeable
conditions of use, taking account, in particular, of
the product’s presentation, its labeling,
instructions for its use and disposal, warning
statements as well as any other indication or
information provided by the manufacturer or his
authorised agent or by any other person
responsible for placing the product on the
market

16. Safety Assessment of Ingredients
Inherent toxicity of
ingredient
Exposure,
concentration of the
ingredient
Chemical
Structure
Implications for the finished product
Safety
assessment

17. Safety Assessment
• Raw Material
• SCCP opinion
• ACSB opinion
• CIR opinion
• Public Scientific
Literature
• Supplier’s data file
• Finished Product
• RM concentrations
• Use quantity and
frequency
• Safety tests done
• In-market data
(complaint level)

18. PIF
5. Existing data on undesirable effects on human
health resulting form the use of the product
6. Supporting data for claimed benefits (efficacy
assessment)
7. Available methods used to check the
ingredients corresponding with the certificate
of analysis (Article 9)
8. Criteria used for microbiological control;
chemical purity of ingredients and/or methods
for checking compliance with those criteria

19. Undesirable Effects on Human
Health
• Need to have a complaint management
system
• Personnel must be trained in data
collection, data analysis and reporting
• Results of investigations must be
documented
• Analysis of trends

20. PIF
5. Existing data on undesirable effects on human
health resulting form the use of the product
6. Supporting data for claimed benefits (efficacy
assessment)
7. Available methods used to check the
ingredients corresponding with the certificate
of analysis (Article 9)
8. Criteria used for microbiological control;
chemical purity of ingredients and/or methods
for checking compliance with those criteria

21. Claimed Benefits
• Based on ingredient properties (from
literature, from supplier’s files, etc.)
• Based on test performed on the finished
product
All claims must be substantiated
If not, claims should be changed

22. PIF
5. Existing data on undesirable effects on human
health resulting form the use of the product
6. Supporting data for claimed benefits (efficacy
assessment)
7. Available methods used to check the
ingredients corresponding with the certificate
of analysis (Article 9)
8. Criteria used for microbiological control;
chemical purity of ingredients and/or methods
for checking compliance with those criteria

23. Article 9: test methods
As these are common to many
ingredients/products they can form part of
a separate file

24. PIF: suggestions
1. Specific part:
• Product name and function
• Formulation
• Method of Manufacturing
• Product specification
• Safety Assessment
• Efficacy Assessment
• Packaging and labeling
• Complaint analysis

25. PIF: Suggestions
2. Ingredient File:
• RM specification
• Supplier data
• Toxicity data – Safety assessment
• First Aid measures (MSDS)

26. PIF
A dynamic set of data influenced by:
– New ingredients
– New RM suppliers
– New production process
– New information available
– New manufacturer
– Etc.
Must be readily available

27. Thank You