Frequently Asked Questions
If you have another question which is not answered here, please feel free to contact us via our Contact Us page, or call 01227 767770
For Manufacturers
How does
PharmAssess™ work?
- Rephine's audit team conducts a GMP audit on the supplier. Once the audit report is completed, the audit report is offered to those customers of the supplier who wish to purchase one.
- A purchaser of a PharmAssess™ GMP audit will sign a ‘Commercial Agreement’. Once payment has been received an audit will be dispatched to the purchaser.
How much does it cost?
- Our European audits cost around £1,000/1,500€ per annum and our global audits cost £1,500/2,250€ per annum.
- This price, on a yearly basis entitles the purchaser to free updates and the re-audit report every two years.
What happens if I would like another site to use the audit report purchased?
You can purchase another report for £250(+ p&p) per annum. This additional report will be produced with the specific site details on the report.
Do the regulatory authorities accept third party audits?
Yes the regulatory authorities do accept third party audits. Please follow the link to the EMEA website to read what they have to say about third party auditing.
We have sent out GMP audits to the UK, Irish, Dutch and Italian regulatory authorities. We would also be happy to send a GMP audit to other regulatory authorities interested in the PharmAssess process.
Will this make my auditing department redundant?
No, PharmAssess™ is a service which can help your auditing department meet legislative requirements by supplementing their efforts.
What standards are used to perform the GMP Audit?
Each audit performed will use GMP standards as a minimum. Other standards will vary according to what type of supplier is being audited.
Will this diminish the relationship between supplier and manufacturer?
No, this service will enhance your relationship, as you are helping your suppliers reduce his costs, whilst you are creating a better quality product by focusing on critical issues faster.
What are the qualifications of the auditors?
Our auditors are graduates and have at least 15 years direct operational experience in either manufacturing or quality management in the Pharmaceutical Industry.
For Suppliers
How does PharmAssess work?
- Once you wish to participate in the PharmAssess service, we will send out a Letter of Engagement and Confidentiality Agreement. We will also be happy to sign company specific agreements.
- Audit standards and the scope of the audit will be agreed.
- The GMP audit will be performed, this usually consists of a two-man, two-day audit.
- An interim report outlining any improvements will be provided.
- The GMP audit report is produced and offered for sale.
- We will re-audit every 2 years, and provide updates over the two year period.
What happens if you find many things wrong?
We provide an interim report and agree a remedial plan for putting any problems right.
How do we ensure confidentiality of information?
We have confidentiality agreements, between Rephine, the Supplier, and the Purchaser. Our GMP audits are produced on quality paper and are bound to minimise the possibility of duplication. Each GMP audit is purchased for use on a specific site and has the details of the purchaser and address on each page of the GMP audit report.
Do I have control over who buys our audit?
Yes completely, the supplier has the right of veto over the sale of the GMP audit report.
Will this reduce our contact with our customers?
PharmAssess™ reduces the time spent with customers on the repetitive, generic issues, but allows any time spent with your customers to be highly productive as you will be able to focus on the specific issues relating to that customer.
Will PharmAssess assure my customers I am in compliance with API legislation?
PharmAssess™ audits will let your customers know that you are compliant with API legislation, as they are carried out to GMP standards by auditors with significant direct operational experience. The EMEA website acknowledges that third party audits are acceptable for compliance with the new API legislation.
