rate overview 2016

1© 2016 McGee Pharma International

Excipient Risk Assessment Tool


your partner in compliance

GMP for Excipients – Formalised Risk Assessment

‘A risk assessment as set out in these guidelines should be carried out

for excipients for authorised medicinal product for human use by 21st

March 2016’



Excipient Guideline 19 March 2015

‘Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal

products for human use’ (2015/C 95/02)

• The appropriate GMP for excipients of medicinal products for human use shall be ascertained on the basis of a formalised risk assessment in accordance with these guidelines.

• The excipient risk assessment/risk management procedure should be incorporated in the pharmaceutical quality system of the manufacturing authorisation holder.

States in the Introduction…



Summary

Expectation is that the Manufacturing Authorisation Holders perform a risk assessment to determine the excipient manufacturers risk profile

A number of steps to be taken to achieving this:

1. Classification of excipients risk profile - Low/Medium/High Risk

2. Determine GMP Controls

3. Classification of manufacturers risk profile - Low/Medium/High Risk

4. Risk Control Strategy

Considerations include:

•Source - animal/mineral/vegetable/synthetic

•Past history of supply

•Purpose and function of excipient

•Patient risk (e.g. route of administration, volume consumed)

•Source of excipient and supply chain

•Supplier history etc.



Requirements of the approach

The RA process should ensure that all elements of the guidance are achieved – holistic risk based management of the excipient manufacturer on the basis of YOUR products

The approach should meet the requirements of the guidance

The approach should be easy to use – this is a complicated process requiring assessment of each excipient across multiple elements (18 minimum metrics)

The approach should not be excessively resource heavy – standardise the approach where possible to make the process more efficient

Where possible, work already completed by the company should be leveraged e.g. development work, toxicological studies etc. – can provide a repository for capturing tacit knowledge on excipients

The process is wider than just the excipient risk profile – it must achieve the end goal of determining the risk profile per excipient, per manufacturer and the control strategy for managing and assessing this on an ongoing basis



The RATE Tool

MPI has developed a management tool to facilitate the conducting of these risk assessments in a formalised manner which could be incorporated into a client’s quality management system.

The design, build, testing and overall validation of the Risk Assessment Tool for Excipients (RATE) Tool took into consideration both

(a) Eudralex Volume 4 Good Manufacturing Practice, Annex 11 ‘Computerised Systems’ and

(b) FDA 21 CFR Part 11



The RATE software

The RATE software will provide a structure to performing the following elements of the assessment process:

• assessment of each of the excipients, from each manufacturer in each formulation to ascertain the worst case use of each material on site against the criteria outlined in the guideline to create the Excipient Risk Profile

• assessment of each material’s individual Excipient Risk Profile to determine the appropriate GMP that should be applied to its manufacture

• determination of the approach that will be taken to assessing the Excipient Manufacturer’s compliance to the required GMP

• assessment of the outcome of the compliance assessment to determine the overall Excipient Manufacturer’s risk profile against the criteria outlined in the guideline to create the Excipient Manufacturer’s Risk Profile



The RATE software

The tool is validated to handle up to 20 formulations and up to 200 excipients (excipients should be added into the tool in groups of 20)

During validation the tool was operated on

Windows 8.1 and Excel 2010 and 2013

and also on Windows 7 and Excel 2010

The tool will be installed at the client site and the accompanying User Manual will support initial training

rate overview 2016

Health & Medicine