Auditorías GMP

Qualipharma GMP Auditing services guarantees the evaluation of compliance of GMPs including both client and supplier’s audits.

Qualipharma provides auditors with proven experience that evaluate the degree of compliance of the GMP in the pharmaceutical plants. Through auditing, every weak point relating to these regulations will be identified, and if necessary an effective corrective action plan will be offered, together with global advice for its implementation.

 

GMP´s Chapter 5, exposes the need to evaluate and to control the suppliers of raw materials, active ingredients, excipients, and so.


GMP´s Chapter 5, exposes the need to evaluate and to control the suppliers of raw materials, active ingredients, excipients, and so on.

Chapter 7 of the GMPs indicates «…The pharmaceutical quality system of the Contract Giver should include the control and review of any outsourced activities. The Contract Giver is ultimately responsible to ensure processes are in place to assure the control of outsourced activities. These processes should incorporate quality risk management principle…»

Qualipharma addresses GMP compliance of suppliers by carrying out audits to raw material manufacturers and to suppliers of subcontracted services such as manufacturing, packaging or any other activity which is considered as critical in the medication manufacturing process.

The Qualipharma auditing consulting service wants to cover supplier homologation in a global manner, we therefore consider among our services the review of supplier auditing results together with its risk assessment in order to establishing meaningful priorities in this service.  Qualipharma consulting team has the necessary experience in the development of risk assessment methodology to be applied to supplier.

Qualipharma takes into account the need to verify with the supplier how far the proposed action plan has been adhered to.  Therefore, in addition to the auditing services, it is possible to hire corrective and preventive action plan (CAPAs) as suggested by the auditing report in a timeframe agreed upon the supplier.

Advantages
  • Risk Assessment in Supplier Certifications
  • Support in risk management for the selection of critical suppliers and in establishing priorities of audits
  • Consultants with experience in auditing GMP compliance
  • Management of supplier CAPAs tracking