INTRODUCTION

The quality of the final product depends not only on the company’s efforts, but also on other factors such as the suppliers. For this reason, it is very important to make sure that suppliers are capable of consistently providing high quality materials. Audits are one of the best methods of ensuring the standardization of the quality of the suppliers.

COMSER has the ability to audit suppliers worldwide. These audits consist of a quality system evaluation to determine if the supplier is producing at the GMP standard. We issue a detailed report of the audit, including any deviations that may be found and recommended measures to correct them. This report provides our clients with the information needed to add, keep or eliminate the audited manufacturer from their approved suppliers list.

Due to our many years in business, we have a vast data base of audit reports of suppliers worldwide.

Audit checklist on a desk
Life cycle of an audit

PREAUDIT

Agreement on the audit´s date: Contact with the manufacturer through the distributer to arrange the date of the audit

Compilation of the relevant information:

-Access to the open part of the ASMF.

-Possible supply incidences that could have taken place.

– Copy of the complete documentation (order, delivery note, analysis certificate of both the manufacturer as well as the laboratory) of at least two batches provided by the manufacturer.

Analysis of the manufacturing process and the product:

The auditor performs an analysis of the risks and determines the most critical steps in the manufacture and control of the active ingredient.

The auditor will agree with the customer promoter on the objectives of the audit and on the regulation to be complied with by the manufacturer. Afterwards he will agree on the complete agenda of the audit with the manufacturer.

REPORT

The audit report is finished fifteen days after performing the audit and handed to the laboratory as a draft for the appropriate comments to be added before the definitive approval of the same.

The audit report consists of:

  • Data of the API, manufacturer and plant location.
  • Brief summary of the audit.
  • Information on the manufacturer, not only on the active ingredient audited.
  • The body of the report includes the most relevant aspects of the audit, not only the deviations, of each of the areas revised.
  • The deviations detected are classified and a generic solution is indicated to correct them.
  • The list of all deviations and recommendations found is indicated schematically.
  • The report ends with the conclusions and the personal opinion of the auditor on the manufacturer.
  • The list of the deviations found is sent to the product manufacturer.

AUDIT

The development of the audit is done in accordance with the following points:

  • Ratification of the objectives and agenda of the audit.
  • Introduction of the plant and the quality system. Review of the open part of the ASMF.
  • Review of the facilities, manufacturing and quality control processes as well as the related procedures.
  • Final meeting where the main deviations found will be discussed and the following steps will be explained (reception of the report, action plan and follow up of the plan).

The audit is done following the guidelines indicated in part II of the European GMP guidelines, as well as the ICH guidelines, EMEA and CPMP.

FOLLOW UP OF THE ACTION PLAN

The company audited must establish an action plan to solve the incidences found during the audit.

There is a follow up of the action plan from the documentary evidences provided by the manufacturer.

PREREQUISITES OF WORK

In order to clearly define our terms for colaboration, it is necessary for you to fill in, sign and send us to the following address the document with a technical agreement and we will provide a document with the confidential agreement.