PHARMACEUTICAL MANAGEMENT SYSTEM

GOST 32893: 2014 Interstate Standard. Perfume and cosmetic products. Methods for assessing toxicological and clinical laboratory safety indicators. Perfumery and cosmetics. methods of evaluation of toxicological and clinical safety indices GMP Good Manufacturing Practic. Good Manufacturing Practice

Good Manufacturing Practice (GMP) is a systematic approach that ensures appropriate production and product control according to quality standards. GMP aims to reduce the risks associated with any pharmaceutical industry. Risks that cannot be eliminated during the testing of the final product.

What will the implementation of GMP bring to your company?

1) GMP includes all the features of production – from raw materials, premises and equipment to the competence and personal hygiene of the enterprise staff and visitors. Detailed documented procedures are necessary for each process that may affect the quality of the final product;
2) GMP requirements are widely recognized as the best way to do business, putting product quality first.
3) GMP refers to the Good Manufacturing Practices Accepted Across the World – Medicines and Cosmetics;
4) non-compliance by firms with GMP standards can lead to very serious consequences, including recall and fines;
5) GMP rules address issues such as record keeping, staff training, sanitation, cleanliness, equipment inspection, process verification, and complaints handling.

Most GMP requirements are very general and open, which allows each manufacturer to individually decide how best to implement the necessary controls.

GMP includes all the features of production – from raw materials, premises and equipment to the competence and personal hygiene of the enterprise staff and visitors. Detailed documented procedures are required for each process that may affect the quality of the final product. It is necessary to have a system that provides documentary evidence that at each stage of the production process, documented procedures are mandatory that are followed – every time a product is produced.

GMP requirements are widely recognized as the best way to do business, putting product quality first.
GMP refers to the Good Manufacturing Practices Accepted Worldwide – in Medicines and Cosmetics. GMP Series standards require manufacturers, processors, and packagers of drugs, medical devices, certain foods, and blood to take active steps to ensure that their products are safe, clean, and efficient. GMP rules require a quality manufacturing approach that allows companies to minimize or eliminate pollution, confusion, and error. This, in turn, protects the consumer from buying a product that is not effective or even dangerous. Failure to comply with GMPs can result in very serious consequences, including recall and fines.

GMP rules deal with issues such as record keeping, staff training, sanitation, cleanliness, equipment inspection, process verification and complaints handling. Most GMP requirements are very general and open, which allows each manufacturer to individually decide how best to implement the necessary controls. This provides more flexibility, but also requires the manufacturer to interpret the requirements in a way that makes sense for each individual business.

The company “Certification, Licensing and Training Center” has many years of successful experience in developing, implementing and documenting the system in various enterprises both in Ukraine and abroad, in accordance with the requirements of the GMP standard.

By contacting us you will receive professional assistance in turnkey development and obtaining a certificate in accordance with the requirements of GOST 32893:2014 / GMP.

The risks of the cosmetic industry are the sum of the GMP risks inherent in enterprises of any industry, as well as special cosmetic risks. The issues of risk analysis in GMP affect the fields of economics, cosmetology, raw materials, competence and even ecology and politics. Moreover, risk management in the quality assurance system in the cosmetic industry is of particular importance. The safety and risk management issues in GMP in the cosmetic and chemical technology sectors need to be considered in conjunction. A cosmetic product can be dangerous as a business product, as a social product and as an information product. Side effects (nutritional risks) are associated with the quality problem that is addressed in GMP. The relevance of the problem posed in GMP requirements is determined by factors that have arisen in modern Ukrainian economic reality.

Enterprises that do not comply with GMP (Good Manufacturing Products) standards will not be able to compete effectively.

The risk assessment in GMP includes two main quantitative characteristics: an assessment of the probability of a risk event and an assessment of the maximum possible damage for this type of risk. The data obtained during the identification, classification and risk assessment of the cosmetic and pharmaceutical enterprises, according to GMP requirements, need to be documented, which is expressed in the construction of risk management functions, the totality of which is combined into a model, which in turn can be optimized, which will mean minimization of possible enterprise losses from all possible types of risk. Risk management in enterprises in accordance with GMP requirements in the cosmetic and pharmaceutical industries in the future will be an objective factor in the survival of domestic enterprises, as well as maintaining a decent level of public health protection.

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