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FAQS
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FAQs - For Manufacturers
How does PharmAssess™ work?
- Rephine's audit team conducts a GMP audit of the supplier’s site.
- When the PharmAssess audit report is completed, the audit report is available to those customers of the supplier who wish to purchase one.
- A purchaser of a PharmAssess™ GMP audit report will sign a ‘Commercial Agreement’ with Rephine Ltd.
- Consent of the supplier is obtained prior to selling a PharmAssess™ audit report to any customer.
- The PharmAssess™ audit report will be dispatched as a securely protected CD to the purchaser.
- Password security details are sent to the purchaser once payment has been received.
Do the regulatory authorities accept third party audits?
Yes the regulatory authorities do accept third party audits. PharmAssess™ audit reports have been accepted by all regulatory authorities to whom they have been presented.
Click on the links below for the views of the European Medicines Agency on third party audits:
EMA statement on third party GMP audits 2006 »
EU GMP Guide Part II Basic Requirements for Active Substances used as Starting Materials - GMP compliance for Active Substances »
MHRA statement on 3rd Party audits »
Further information on regulatory and procedural guidance is available on
the EMA website.
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 their auditing costs, whilst you are focusing on other relevant issues.
What are the qualifications of the auditors?
Rephine’s auditors are graduates and have many years direct operational experience in either manufacturing or quality management in the Pharmaceutical Industry. Many of our auditors are QPs.
FAQs - For Suppliers
How does PharmAssess™ work?
- Once you wish to participate in the PharmAssess™ service, Rephine will send out a Letter of Engagement, and Confidentiality Agreement. Rephine is also prepared to sign other company specific agreements.
- Audit standards and the scope of the audit will be agreed.
- The GMP audit will be performed, usually consisting of a two-day audit.
- An interim report outlining any improvements will be provided.
- The PharmAssess audit report is produced and offered for sale.
- Rephine will re-audit every 3 years, and provide updates periodically.
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?
Rephine is a highly professional organization aware of the need for confidentiality of sensitive information. Confidentiality agreements are signed between Rephine, the Supplier, and the Purchaser.
The PharmAssess™ GMP audit reports are produced electronically with security controlled access . Customers will not be able to purchase a PharmAssess™ audit report from Rephine without the permission of the supplier.
Each PharmAssess™ GMP audit report relates to a particular site and has the details of the purchaser and supplier site address on each page of the audit report so is specific to a supplier and customer
Do I have control over who buys our audit?
Yes completely, the supplier has the right of veto over the sale of the PharmAssess™ GMP audit report.
Will this reduce our contact with our customers?
PharmAsses™ reduces the time spent with customers on the repetitive, generic issues, but allows more time to be spent with your customers and for it to be highly productive as suppliers 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™ audit reports 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:
EMA statement on third party GMP audits 2006 »
EU GMP Guide Part II Basic Requirements for Active Substances used as Starting Materials - GMP compliance for Active Substances »
MHRA statement on 3rd Party audits »
Which APIs are covered by a PharmAssess audit report?
A PharmAssess audit assesses the overall systems and processes at a manufacturing site and therefore the report will cover ALL the APIs produced at that site.