Pharmalence Limited Consultancy and Outsourcing services for the Life Sciences Industries

Quality Systems and GMP Auditing Services

Pharmalence Ltd., offers two types of auditing services. The first is in-house facility auditing, whereby the auditor will conduct an inspection of the facility quality systems and prepare a report to identify observations that need to be addressed by the facility. This type of audit can serve as a pre-inspection audit, prior to a regulatory inspection. The second type of audit is a supplier qualification audit, whereby we will inspect a contract laboratory or supplier from which your facility intends to or already sources services or raw materials.

Quality Systems / GMP Facility Auditing

On-site Facility Audit
This type of audit is conducted by the auditor visiting your site and spending a number of days touring the facility and reviewing the relevant documents and records. The length of the inspection depends on the size and complexity of the facility as well as the pre-agreed scope of the inspection. The process typically involves:

1. an initial meeting, whereby the auditor will discuss with the management the scope of the audit
2. review of top-level documents to get a clear picture of the processes involved
3. facility tour during which the auditor will take note of documents and records that will be requested in the next step
4. review of process specific documents and records
5. compilation of an audit report highlighting the observations and also a classification of their criticality
6. discussion of the audit report with management and proposing relevant CAPAs

Desk-top audit
This is the cheaper option of a quality system audit and applies to those companies that would like to get a feel of where their systems are before actually going for an on-site facility audit option. In a desk-top audit, the auditor would not visit the facility. The process, in this case, would be as follows:

1. A questionnaire is sent to you that contains request for information related to your processes and quality systems
2. Together with the completed questionnaire, you will also be asked to forward a copy of key documents, such as, the site master file or quality manual, validation master plan, organizational chart, typical batch manufacturing record and an annual product review report.
3. The auditor will then review the documents and completed questionnaire. During this time you may be contacted by the auditor for clarifications and / or request for further documents.
4. An audit report highlighting the observations and also a classification of their criticality would be compiled by the auditor and forwarded to you.

Suppliers' quality systems auditing

We offer the service of auditing your suppliers' quality systems on your behalf. The type of suppliers that we can audit include:

1. API (active pharmaceutical ingredients) suppliers
2. Excipients suppliers
3. Packaging materials suppliers
4. Contract manufacturers
5. Contract packaging facilities
6. Contract analytical laboratories
7. Contract microbiological testing laboratories
8. Contract sterilization facilities

Contact Us to ask for a quotation or if you would like to know more about our auditing services.