blog post

ISO 22716

GMP – WHO (Modern certificate of Pharmaceutical product)
GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.

Cosmetics Good Manufacturing Practices are a set of hands-on advice, operational rules and organizational guidelines especially focused on human, technical and administrative factors affecting product quality. As of 11 July 2013, the European Union’s new Regulation (EC) No 1223/2009 will require cosmetic products to be manufactured according to Good Manufacturing Practices (GMP). Cosmetics manufacturers should prepare for this new requirement now in order to avoid any loss of market approval.

One way to demonstrate compliance with GMP is to implement the international standard ISO 22716. ISO 22716 introduces a management systems approach for 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.
This regulation sets very high requirements to ensure consumers’ safety.

Benefits of ISO 22716 standard?

Being ISO 22716 certified means your Organization is following guidelines for :


Production, Management, Storage and Transport of cosmetic products.


Defining conditions regarding the quality aspects of the product.


Assuring the customers' safety, traceability and responsibility.


Improving the production quality management


Defining and managing critical points in production


Reducing the number of complaints


Defining competencies and responsibilities


Confirming implementation of legislative requirements

Procedure for the ISO 22716  Certification

Gap Analysis: Firstly we work on the areas where the organization is at present position and how ISO standard is working and find the gap.

Implementation: Our company provides training according to ISO 22716 standard, than after review the whole process of implementation training  and if it is working properly than we establish that process as system. Once we make proper system, your organization is able to work properly as per standard even in our absence.

Certification audit: The certification process proceeds in two stages. The audit team examines if the documentation of your management system already complies with the standard. Subsequently you demonstrate the practical application and effectiveness of your management system.

Issuing the certificate: After a successful certification process your company receives the certificate. It certifies compliance with the standards and operability of your management system.

Our experts will be more than happy to assist you should you have questions or require any further information on the ISO 22716 certification of your Modern certificate of Pharmaceutical product