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ICH Q3D   The first version of the ICH Q3D guidance was published in 2016, to control elemental impurities in medicinal products for human use within acceptable limits. For veterinary medicinal products, it was recently published in early 2020. The presence of elemental impurities in pharmaceuticals has traditionally been monitored by the so-called heavy metal […]

On 28/01/2022, the new Regulation (EU) 2019/6 on veterinary medicinal products and Commission Implementing Regulation (EU) 2021/1281, laying down rules for application as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products entered into force. As a result, Directive 2001/82/EC and Regulation (EC) […]

Commission IMPLEMENTING REGULATION (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices was issued in Brussels last 14 December 2021. Regulation (EU) No. 207/2012 on electronic instructions for use of medical devices is repealed with […]

The Product Information File (PIF) is a mandatory document for the marketing of cosmetic products. Regulation (EC) Nº 1223/2009 tells us that we must have a PIF for each cosmetic product marketed, and also maintain it for up to ten years after the last batch of said product has been placed on the market. This […]

The Product Information File (PIF) is a mandatory document for the marketing of cosmetic products. Regulation (EC) No. 1223/2009 states that we must have an PIF for each cosmetic product marketed, and additionally maintain it for up to ten years after the last batch of said product has been placed on the market. This file […]

Labeling is one of the key points of our cosmetic product, and it must contain minimum information such as the batch or quantity. Article 19 of Regulation (EC) No. 1223/2009 indicates the minimum information that must appear on the labelling. There is information not required on the labelling, such as the address of the distributor […]

Manufacturers of cosmetic products are required to submit a Statement of Compliance to the Spanish Agency of Medicines and Medical Devices (AEMPS). The manufacturer is required to list all the activities for which it is responsible in this document, including its own activities and subcontracted work. This statement demonstrates that the manufacturer produces products in […]

According to the Regulation, the main terms to be considered are as follows: Cosmetic product: any substance or mixture intended to be placed in contact with the superficial parts of the human body (i.e., epidermis, hair and capillary system, nails, lips, and external genitalia) or with the teeth and oral mucous membranes for the sole […]

Auditors’ qualification key point audit execution The training and qualification of the auditors’ team is a key point for achieving the best results during the audit program execution. The quality of the audit will depend mostly on the expertise and capabilities of the auditors. The audit team could be formed by any employee of the […]

Quality Audits Management System The Quality Audits should be managed according to the Quality Management System requirements, that should include: A risk based planification system for audits to be performed within a certain period of time. Effective training and qualification programs for the auditors, including clear requirements for their approval. A well defined system for […]