Due Diligence - More
We can tailor our investigations to any particular client's requirements.
The following points can serve as guidelines:-
- Facility Design and Services -
What is the level of operational and GMP compliance?
Are process, material, and personnel flows in compliance
with regulatory requirements.
- Management Team and Structure -
Suitability, strengths, weaknesses, capability, stability,
succession planning.
- Products and Processes -
Do they comply with specifications and regulatory requirements?
- Quality Systems -
Do they work? Are they straightforward?
Do they meet regulatory requirements?
- Health & Safety -
What is the company's policy, track record, record keeping,
potential future liabilities?
- Quality Assurance Laboratories -
Are they adequately equipped, staffed, and operated to
satisfy regulatory standards?
- Customer Complaints -
Is there a formal system and are they used for information,
training, and improvement?
- Relationship with the Regulatory Authorities -
Is there one?
- Plant and Equipment -
Is it adequate, in good condition, validatable, & validated?
- Fabric and Technical Infrastructure -
Are there any nasty surprises for the buyer?
(we don't mind going into difficult spaces)
- Work in progress -
Is it as listed and of the value stated?
- IT systems -
Are these an accident waiting to happen?
Are all relevant systems validated?
- Engineering and Maintenance -
Is there a full system of Planned Preventative Maintenance and
a Calibration Programme, and are these adequately fulfilled?
- Training -
Does this happen?
Is it adequate and recorded?
- Security -
Is the plant physically secure?
How is theft and potential sabotage prevented?
If you are involved in the M & A process in the Pharmaceutical, Healthcare, or related industries, then Rephine can provide a 'one-stop-shop' for all aspects of operational due diligence.
Please contact us on 01227 767770 or use our contact form to send us a message.
