Good Manufacturing Practice

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What?

gmp
ISO 22716:2007 is the international standard that gives guidelines for the production, control, storage and shipment of cosmetic products in compliance with Regulation (EU) No. 1223/2009.

Why?

Responsible Person has to ensure the conformity of every batch of the cosmetic product he places on the market. Since the compliance to the GMP is one of the obligations of the Responsible Person (art. 5) and since the declaration of conformity of the RP is one of the documents listed in the PIF requirements (art. 11), it is clear that the implementation, monitoring, management and demonstration the application of GMP are key issues in the compliance of cosmetic products.

How it works?

The Standard describes a list of requirements that has to be allowed (instructions, aims, documentations). The manufacture of cosmetic products should comply with GMP and not necessarily certified. Audits should be conducted by a team that is aware of the critical production parameters for the product specifically designed for the RP. Therefore, the auditors have to be experts (or assisted by a team of experts) on all issues of the Safety Assessment.

How can we help you?

The verification of the application of the GMP might be very expensive, especially in case of the very articulated companies with many manufacturers from different countries. We can help you to guarantee the GMP implementation, contact with the manufacturer directly and perform auditing of the manufacturer if necessary.

In order to rationally manage with GMP, we can provide you with our assistance thanks to following skills:

  • Auditing by own GMP experts
  • GMP implementation of the manufacturer’s activity
  • Direct contact with the manufacturer
  • Correlation of the GMP implementation and the Safety Assessment
  • Optimization of the supply chain’s work

The Regulation (EC) 1223/2009

The Regulation (EC) 1223/2009 introduces the application of the Good Manufacturing Practice according to the existing international standards and therefore refers to the international standard ISO 22716:2007.
This standard, which substitutes the much simpler local laws, is structured and detailed according to an approach similar to the ISO 9000 standard (this fact actually facilitates the ISO 9000 certified companies, without preventing anyone to respect the requirements of the GMP regulations).

The pertaining aspects are:

PERSONNEL
PREMISES
EQUIPMENT
RAW MATERIALS AND PACKAGING MATERIAL
PRODUCTION
FINISHED PRODUCTS
QUALITY CONTROL LABORATORY
HANDLING OF THE PRODUCT WHICH DOES NOT COMPLY WITH THE SPECIFICATIONS
WASTES
SUBCONTRACTING
DEVIATIONS
COMPLAINTS AND WITHDRAWALS
CONTROL OF THE MODIFICATIONS
INTERNAL AUDIT
DOCUMENTATION

The role of Angel Consulting

Angel Consulting, thanks to our experience in the field of international standards of good manufacturing practice and perfect knowledge of quality systems according to ISO standards (ISO 9000 for quality systems and ISO 13485 for medical devices companies), may help you better understand how to comply with ISO 22716 standard, assist you (if required and desired) on the way to obtain the certification by accredited institutions.