Pharma & Cosmetics

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New Pharma & Cosmetics Audit

From January 2019 we will offer II Party Audit on ICH Q7, the pharma GMPs and ISO 22716 the Cosmetics GMPs, following also the EU REG N. 1223/2009.

Our availability is in USA, Canada, EU and Middle East.

Claudio Gallottini is an effective member of ECA and ISPE.


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Early in the ICH Process it was agreed that there was adequate international agreement on the technical aspects of Good Manufacturing Practices (GMP) for Pharmaceutical Products and that further harmonisation action through ICH was not needed. Recently, however, attention has focused on the need to formalise GMP requirements for the components of pharmaceutical products - both active and inactive. In February 1998, the ICH Steering Committee agreed that GMP for Active Pharmaceutical Ingredients (APIs) should be adopted as an ICH Topic.

When this topic was adopted, the Steering Committee took steps to ensure that due account was taken of the work already in progress by PIC/S, FDA and other parties. In view of the unusually wide implications of this Topic, a much extended EWG has been established which includes, in addition to the six ICH parties and the Observers, experts representing IGPA (generics industry), WSMI (self medication industry) and PIC/S. With respect to the latter representatives from China, India and Australia have been invited to participate.

ICH Q7 Guideline



EU Regulation 1223/2009 & ISO 22716

ISO 22716:2007 is the international standard for the good manufacturing practices (GMP) for cosmetics. The guidelines for the standard has been approved and accepted by a many global regulatory bodies, such as the International Cooperation on Cosmetics Regulation (ICCR), Food & Drug Administration (FDA) and the European Committee for Standardisation (CEN).

The ISO 22716 standard has been prepared for consideration by the cosmetic industry and take into account the specific needs of this sector. The standard focuses on the production, control, storage and shipment of cosmetic products. These guidelines offer organizational and practical advice on the management of the human, technical and administrative factors affecting product quality.

Good manufacturing practices (GMP) are essential to any organization looking to reduce the risk and liability of their costmetic product that can result from poor handling within their operation.

ISO 22716 introduces a management systems approach to documenting and regulating the production, control, storage, and shipment of cosmetic products. The standard’s guidelines will provide your organization with practical methods for managing the many factors that can affect product quality.

EU Regulation N. 1223/2009
This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.

EU Regulation N. 1223/2009