Call +386-40 133 266 | Email office@burstein-eu.com

Procedure

The most important part of a RP is to keep PIF (Product Information File) on the registered address for each product responsible. PIF file has a certain structure (some kind of a “tree form”), which enables adding/changing/withdraw of old/new versions of documentation. PIF file is like a “live organism”, which is changing with the current legislation in force. The PIF consists of a set of different specifications and tests, we have divided these sets of information into 4 parts:

- General part

- Raw materials part

- Finished product part

- Packaging and labelling part

 

GENERAL PART: The information we are going to collect in THIS part is the following:

- Qualitative and quantitative composition of each product (in Burstein format we provide to you)

- Good manufacturing practice (GMP ISO 22716 certificate, has to be issued by the producer of the products)

- Method of manufacturing: a flow chart including manufacturing operations

 

RAW MATERIALS PART: The information we are going to collect in this part is the information which can usually be found in the raw materials’ Material Safety Data Sheets (MSDS), Technical Data Sheets (TDS), Certificates of Analysis (CoA) and/or raw materials sales specifications (we request MSDS and COA or TDS for each raw material).

 

FINISHED PRODUCT PART: The information we are going to collect in this part is the following:

- Physical/chemical characteristics of finished products

- Microbiological specifications of finished products

- Results of the stability test (physical/chemical stability, packaging stability)

- Results of challenge test (microbiological stability, preservation test)

- Proof of the effect claimed, if any

- Safety assessment (all tests necessary for the safety assessment can be provided by our company – their description is found here.

 

PACKAGING AND LABELLING PART: The information we are going to collect in this part is the following:

- Characteristics/specifications and purity of the packaging material

- Packaging stability and compatibility (test can be performed simultaneously with physical/chemical stability)

- Product labelling: outer packaging labelling, product container labelling, stickers/leaflets/cards etc. if applicable

- Photograph of the corresponding packaging

 

When all needed documents are received and the PIF file is prepared, we can than start with notifying products into the CPNP system. Summary of this system is found here.

Copyright © 2017 Dr. M. Burstein d.o.o. All Rights Reserved.