| Main legal acts | |
|---|---|
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EEC decisions: № 526 № 293 № 294 № 299 № 41 № 44 |
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| IFCG Services | |
| - Certificate of Conformity TR EAEU - Declaration of conformity with TR EAEU - Certificate and Declaration GOST R - Certificate of state registration - Development of product labeling |
Certification for serial production of goods
As a rule, a certificate (declaration) for serial production is issued in the following cases:
- With long-term deliveries of large volumes of products;
- when releasing goods with a limited range of products;
- in the production of products in periodically repeating batches.
The procedure for certification of serial production of goods is established by the Regulation "On the procedure for the application of standard schemes for assessing (confirming) compliance with the requirements technical regulations Customs Union”, approved by the Decision of the Commission of the Customs Union dated 07.04.2011 No. 621. This decision also establishes the procedure for certification (declaration) of a consignment of goods and a single product. You can read more about the features of certification of a batch and a single product and.
Features of product series certification
With stable serial production, it is quite convenient to issue a certificate specifically for serial production, since this document can be valid for a rather long period (up to 5 years), its validity will apply to all similar manufactured products (of this applicant and manufacturer). In addition, a certificate for serial production does not limit the number of products released, such as certification of a batch of goods.
However, obtaining a certificate for a series is associated with certain difficulties. In addition to sample testing, it may also be necessary to evaluate the state of production or certify the quality management system. One or another option for providing evidence of product safety is established depending on the selected standard scheme.
Analysis of the state of production
Analysis of the state of production is an assessment of the availability of the manufacturer necessary conditions to ensure compliance of manufactured products with the requirements of specific technical regulations of the Customs Union. Manufacturing research includes:
- Verification of documentation (operating instructions, test reports, specifications, GOSTs, statutory documents, product catalogs, certificates (declarations) for materials or components, etc.);
- research of infrastructure (equipment, technical equipment);
- checking the competence of personnel;
- verification of compliance with procurement requirements;
- checking the availability of the necessary measuring instruments and their compliance with the established requirements;
- checking the correctness of product labeling;
- etc.
The objects of analysis are selected by experts based on the characteristics of production and products. In each individual case, at the discretion of the expert, the composition of the objects of study may be changed or supplemented. Certain features of the analysis of the state of production are established in the Technical Regulations of the Customs Union.
Based on the results of the study, the expert draws up an act of analysis of production. In the act, the expert indicates the identified violations (lack of documentation, incorrect labeling, improper operation of equipment, lack of necessary qualifications for personnel, etc.), a general assessment of the state of production, and his recommendations. A positive expert opinion is the basis for issuing a certificate for serial production of goods. Analysis of the state of production is provided for by standard schemes 1s, 5s, 7s. Scheme 5c is used for mass-produced products, if it is completely impossible or difficult to confirm compliance with the requirements during testing. finished product. Scheme 7c is used for complex products intended for serial and mass production, as well as in the case of release planning a large number product modifications. For all other cases, scheme 1c is used.
Not all Technical Regulations provide for the possibility of choosing between these schemes. So, for example, TR TS 004/2011 "On the safety of low-voltage equipment", TR TS 008/2011 "On the safety of toys", TR TS 007/2011 "On the safety of products intended for children and adolescents", TR TS 010/2011 " On the safety of machinery and equipment”, TR TS 020/2011 “Electromagnetic compatibility technical means” and others provide for an analysis of the state of production only according to scheme 1c. TR TS 019/2011 "On the safety of personal protective equipment" established schemes 1s and 5s. TR TS 006/2011 "On the safety of pyrotechnic products" - scheme 7c. If it is difficult to assess the state of production, it is possible to apply verification of project documentation.
In the serial production of goods, if the applicant has a quality management certificate, it is possible to use certification schemes 2c, 6c and 8c.
Quality Management Certificate
A quality management certificate is a document confirming that the company that manufactures this product, a quality management system has been developed and implemented, i.e. work is organized in accordance with international standards. Quality management system standards developed by the largest international organization on standardization (International Organization for Standardization).
A quality management certificate (QMS) is a voluntary document that can be issued to any company, regardless of its field of activity. The basis for the issuance of the document is the results of the review by experts of the submitted documentation and the certification audit at the enterprise.
The ISO 9001:2008 family of standards specifies requirements for quality management systems and is the only standard against which certification can be made.
The quality management system implemented at the enterprise is a kind of guarantor of the high quality of products, which in turn increases the competitiveness and efficiency of the organization.
It is important to note that the fact that an enterprise has a quality management certificate does not exempt from obtaining a mandatory certificate of conformity for its products.
What is the concept of a “series of a medicinal product” for? Why is the batch size of a medicinal product required to be declared when registering a drug? How many finished products can be considered a commercial batch of a medicinal product? How does this affect the safety and efficacy of the drug?
The idea to “understand” the formation of a series of a medicinal product arose quite a long time ago, however, for a long time, colleagues dissuaded them from interpreting them, arguing that the opinion presented below would most likely cause a “flurry” of emotions and individual tantrums…
Question 5: Are there any criteria for the formation of a batch of FPP if it is necessary to separate intermediate products in separate operations?
When conducting state registration of any medicinal product, it is necessary to declare the standard batch size in the materials of the registration dossier, and if you wish to change it, you must enter official changes and provide convincing evidence of this possibility. Plastic bag technological documentation(manufacturing recipe, technological instructions and packing instructions) are developed for each declared batch size. The batch size is used when choosing a cleaning validation methodology, etc.
What is the GLS series? According to the definition of GMP and the European Directive 2001/83/EC, “a batch (batch or lot) is a set of dosage form units obtained from a single amount of raw materials during a sequence of technological operations and / or sterilization cycles under conditions that guarantee the homogeneity of the product . In continuous production, a finished product series refers to all units of a dosage form manufactured in a specified period of time and characterized by uniformity. The batch size can be determined either by a fixed quantity, or by the quantity of product produced in a fixed time and submitted for quality control at the same time.
As can be seen from the definition, the concept of a batch and its size is closely related to the concept of “homogeneity of dosage units”. At its core, the homogeneity of the distribution of active substances in a dosed medicinal product is key indicator the quality of the medicinal product. The uniformity of the dose of the drug affects the reliability of the results of ongoing clinical trials, the confirmation of bioequivalence, the results of stability studies, and even the frequency of adverse reactions (registered in the pharmacovigilance system).
The problem of ensuring the homogeneity of a batch of a medicinal product is well known. The effectiveness and safety of the drug directly depends on providing the patient with a homogeneous dosage form. Therefore, most regulatory authorities, when agreeing on a package leaflet for a medicinal product, prohibit splitting the dosage form of the drug, and if this is allowed, the dosage form must ensure this (for example, a risk must be provided on the tablet), and the release specification must included the test "Uniformity of dosage units" in accordance with section 2.9.40 of the European Pharmacopoeia, which involves the assessment of the uniformity of each individual part of the dosage form.
At the same time, the problem lies in the fact that the GMP requirements do not contain clear definitions and specific provisions on the issue of batch formation and determining its acceptable size, leaving this at the mercy (responsibility) of the FPP manufacturer and government agency for the registration of drugs. At the same time, GMP does not exclude the possibility of dividing the product into the required number of sub-series at certain stages of production, which are subsequently combined into a homogeneous product series. This possibility, in turn, leads to differences in understanding among pharmaceutical industry specialists.
In the post-Soviet countries, the most common practice is to form a series according to the “narrowest” unit of the used technological equipment, in Western countries - according to the concept of "ensuring the homogeneity" of the product.
The policy of forming a series according to the “narrowest” piece of equipment, from the standpoint of uniformity, obviously, can be considered ideal. The problem is different, the abuse of this approach can lead to unjustified costs for quality control, logistics operations, distortion of the evaluation results in the annual Drug Quality Review, unconscious (and perhaps conscious) concealment of technological problems associated with ensuring product homogeneity.
The "golden" standard for uniformity
In the context of process validation, the quality of a medicinal product means “the fitness of the drug for its intended use from batch to batch, and directly in each unit of the dosage form. It is well known that the homogeneity of the series is "laid" at the stage that forms the dosage form.
Let's imagine the situation on the example of the most common dosage form (see Fig. 1). The tablet mass is obtained by mixing five granulates, successively obtained in the installation of a fluidized bed GF-10. Next, tableting is carried out on tablet presses GF-31 and / or GF-32, and, accordingly, the subsequent application of a film shell in GF-40. The obtained tablets are packed on the line GF-51 and/or GF-52.
If 5 granulates from the GF-10 plant are simultaneously mixed in the GF-20 mixer, and then the entire tablet mass obtained is tabletted on one of the GF-31 (or GF-32) tablet presses, after which the entire number of tablet cores is simultaneously covered with a film shell in installation GF-40, it is obvious that the series of FLS will be formed exclusively in the mixer GF-20 at the stage of obtaining the tablet mass and the size of the series will directly depend on the volume of such a mixer.
In fact, the problems arise elsewhere. Where is the FPP series formed, if several tablet presses are used in production (GF-31, GF-32) and / or film coating of tablets must be carried out in a number of sequential operations on GF-40, or coated tablets are packaged over several shifts and / or on various packaging lines (GF-51, GF-52) ? At the stage of obtaining the tablet mass or at the stage of tableting, or maybe at the stage of coating the tablets with a shell, or still when packing the tablets?
I don't think you should rush to answer. Yes, and the answer is not so clear, it requires detailed consideration and assessment based on risk management methodology (ICH Q9).
Using two tablet presses
On the one hand, we have the uniformity of the tablet mass, which a priori ensures the uniformity of the tablets, on the other hand, the tableting parameters, the degree of adjustment of the tablet press have a direct impact on the uniformity of the dosage form.
Conclusions: The homogeneity of a series of drug products in the form of tablets directly depends on the uniformity of the tablet mass and tableting parameters. Therefore, tabletting of a homogeneous tablet mass simultaneously on two different tablet presses, albeit identical, must be considered as the production of two different series of FPP.
Using multiple tablet coating operations
Let's discuss the situation (see Fig. 2) when an OTC manufacturer receives 300 kg of tablet weight, from which 600,000 core tablets with an average tablet weight of 500 mg can be produced. Next, the tablet is transferred to the film coating in the appropriate installation. However, the machine can cover up to 100 kg (200,000 tablets). The problem is simple - what will be the size of the batch of the drug? There are only three answer options - 200,000, 600,000 or 1,200,000 coated tablets, respectively? Which option do we choose?
Rice. 2 - An example of the formation of a series of medicinal product for film-coated tablets
On the one hand, all the above considerations indicate that the size of the FPP series according to this example- 600,000 tablets p/o (based on the homogeneity of the dosage form). But, on the other hand, after all, the application of the shell is carried out not in the course of one operation, but in a cycle of three successive operations. And then, how to actually perceive the concept of "sequence of technological operations", stated in common definition LS series? This is one coating operation in a set of technological operations for obtaining a dosage form, or a certain number of coatings carried out during one work shift? So maybe the batch size should still be 200,000 p/o tablets? The answer depends on how much the homogeneity of the FPP series can change when the shell is applied to the core tablets of the same series during three successive operations under standard conditions?
Obviously, the variable is the quality of the coverage itself (visual and functional characteristics). Let now you think that the shade of the color of the shell may differ for each individual coating operation. We put the question in a different way, “Can the color (its shade) of the tablet shell change between successive operations on the same serviceable qualified equipment, under standard (validated) conditions and the used composition of coating suspensions”? Of course it can, but only when there is no stable and well-chosen composition of the film coating, the selected operating modes of the equipment are incorrect and there are problems with it. technical condition. Therefore, the formation of a series of drug products at the stage of coating the tablet cores can be regarded, for example, as (un) deliberate concealment of existing technological problems.
As a result, if the film coating is applied with a protective purpose (protection of the dosage form from external environment, or masking of taste and / or color characteristics), it does not affect the uniformity of the drug, but if the shell provides a modified release of the drug, then it is more difficult, because the dose received by the patient may depend on the variation in the characteristics of the film coating in a series of tablets.
Conclusion: Formation of a batch of 200,000 film-coated tablets, with any type of coating, can really be considered a priority option - because from the standpoint of batch uniformity, this is simply wonderful! The question is how much it is necessary, what it gives the patient and how much it will cost the OTC manufacturer. Therefore, if the tablet is coated, the logical answer would be a batch size of 600,000 p/o tablets (see Fig. 2). If, however, the coating provides a sustained release of the substance(s), then a batch size of 200,000 p/o tablets would most likely be reasonable, although with sufficient (documented) experimental data, a batch size of 600,000 p/o tablets may be considered acceptable.
Then another question arises, if we have already begun to think creatively - Let's mix the coated tablets, regardless of their number, in some way immediately before packaging (for example, in a mixer according to the "drunken barrel" principle), i.e. let us combine (average) 6 (six) coating operations at once into one series (see Fig. 2), obtaining a series equal to 1,200,000 coated tablets.
There is only one answer - it is categorically impossible to form a commercial series of FPP from semi-products obtained under various conditions. 300 kg of tablets made from a homogeneous tablet mass cannot be adequately mixed with another 300 kg of tablets made from a different tablet mass - this is physically impossible (and not provable)! Mix two 300 kg tablet masses in one 600 kg mixer, tablet on one tablet press and form a series of 6 film coaters (100 kg each).
Packing on several packaging lines
In accordance with paragraph 4.2 of Annex 19 of GMP: “... If the batch is packed using two or more separate packaging operations, at least one archival sample should be taken at each individual packaging operation. Any proposed exception to this condition must be justified and agreed with the competent authority.”
The question is, what counts as a packaging operation? For example, if the packaging of a batch of a drug is carried out during several work shifts, this is not the basis for issuing separate batches for each shift. It is obvious! Another question is whether the packaging of one series can be carried out on several packaging lines (read, separate operations)?
Tablet filling operations cannot affect the homogeneity of the FPP batch. The issue of microbiological contamination, tightness and completeness of the primary packaging is related to quality assurance and GMP compliance.
Therefore, if the packaging lines are installed in the same production area, have identical packaging units, it may be quite reasonable to pack the FLS series (in relation to the example under consideration) on different packaging lines.
Otherwise, let's talk about manual packaging. If a batch of a drug is packed by different packers, or, God forbid, by different teams, then the FPP batch is the rate of output of the packer (team) per shift. Probably absurd, although it has the right to life!
General Conclusion
The issue of series formation and its size is extremely complex. When justifying the size of commercial batches, it is important to recognize that any decisions are always associated with an understanding of the available information and knowledge about the drug, the features of the technology of the claimed dosage form and the nature of variations (variability). To form a batch size justification policy, it is necessary to identify the sources of variability (variation) of homogeneity, have confirmed information about the presence and extent of such variations, and accordingly assess the impact of technological operations on the quality (compliance with the specification, safety and efficacy) of the drug using quality risk management methodology.
We must not forget the meaning of process validation is the collection and evaluation of data that provides scientific evidence that technological process capable of consistently delivering quality products. And isn't validation the basis for justifying one or another batch size obtained in a sequential series of technological operations, which makes it possible to ensure (and not violate) the uniformity of each dosage unit in the series.
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The number of litigation related to thermolability of drugs is increasing. This was discussed during the round table "Validation of the transportation process medicines», organized by the Council supply chain professionals, said Head of Healthcare practice law firm Pepeliaev Group Alexander Panov.
The event was held as part of the third meeting working group"Pharmaceutical Logistics" and brought together leaders logistics companies, as well as representatives of pharmaceutical manufacturers and distributors.
The head of the Vialek Group of Companies, Alexander Alexandrov, drew attention to the fact that deviations in the temperature regime do not always lead to a discrepancy between the product and the proper level of quality. According to him, transportation without deviations does not happen, as evidenced, among other things, by foreign experience.
“It is impossible to ensure that the temperature regime does not go beyond the limits even for a minute,” he stressed. “Another issue is that we should not allow long-term deviations, and from a legal point of view, this still needs to be finalized, because now this issue is often equated.” Another common mistake is to measure the temperature of the air rather than the temperature of the product during transport, he added.
Continuing the theme of inaccuracies in the definitions, the expert noted that the manufacturer and the holder of the registration certificate are responsible for the quality of the products. And in this regard, there is no need to manipulate the concepts of "efficacy and safety."
“Safety and efficacy are confirmed at the stage of preclinical and clinical studies,” he recalled. - Logisticians ensure this through the application of good practices. But to say that during transportation it is necessary to ensure the safety and effectiveness of the drug is incorrect - carriers must guarantee that the transportation of the goods did not have any effect on the quality of the product.
Read the details in "FV" No. 23 (978) dated 07/23/2019 in the publication "How Lucky". 
The topic of this article is devoted to the issues of obtaining a mandatory certificate for products supplied during the entire period of validity of the certificate. In addition, we will consider the key points of registering a declaration of conformity for a series of goods.
Certification options, as well as declaration of conformity of a product series, are considered taking into account the requirements of the technical regulations of the Customs Union.
Mandatory certification of a series of goods is carried out according to the same principles as certification of a batch or a single product: the verification is based on the principle of complete confirmation of the set values by the established safety standards. At the same time, the process of obtaining a certificate for a series has its own peculiarities.
Product Series Certification Features
Declaration of conformity of a series of goods
You can register a declaration for serially supplied products in one of two ways, as in the case of declaring a lot:
- On their own security justifications.
- Based on own safety justifications and evidence obtained from an accredited testing laboratory.
If the technical regulation of the Customs Union does not establish a declaration method for a certain group of goods, then the applicant has the right to choose how to register the declaration.
When declaring a series of products, there are also several differences from declaring a lot. First, in addition to testing type samples, the manufacturer must production control and submit the act with its results to the certification body. Please note that such a check is assigned to the manufacturer.
In addition, when declaring a series of goods on their own justifications, tests must also be carried out by the manufacturer himself.
Secondly, in some cases, when declaring the conformity of a product series, the applicant has the opportunity not to test the finished product. Instead, type exploration is performed.
Product Series Compliance Schemes
The Commission of the Customs Union adopted Decision No. 621 dated April 7, 2011, which defines standard schemes for certification and declaration of conformity of products within the framework of the requirements of the technical regulations of the Customs Union.
Product Series Certification Schemes
You can obtain a mandatory certificate of conformity for a product series according to one of six certification schemes: 1s, 2s, 5s, 6s, 7s or 8s. In each case, a scheme is selected that is most suitable for the type of production.
The applicant under all schemes can only be the manufacturer himself, including a foreign one, if there is an authorized person in the territory of the Customs Union.
Under normal conditions, certification is carried out according to schemes 1c or 2c, which are based on testing of type samples in accredited laboratories. In cases where it is impossible or difficult to fully test the finished product, schemes 5c or 6c are applied. And, finally, in cases of the release of complex products intended for mass production or when planning a large number of modifications, schemes 7c or 8c are chosen.
At the same time, choosing each of the schemes, it is necessary to take into account their mandatory components:
Table 1. Components of Product Series Certification Schemes
In this case, the study of the type is carried out in one of the following ways:
- study of a sample for planned production as a typical representative of the entire future products;
- analysis technical documentation, testing of a product sample or critical product components.
Under the study of the project is understood the analysis of the technical documentation, according to which the products are manufactured, as well as the analysis of the results of the calculations, tests of experimental samples of the products.
Schemes for declaring a series of goods
Four schemes are provided for declaring the conformity of a product series: 1d, 3d, 5d or 6d. Of these, it is possible to register a declaration on your own safety justification only according to scheme 1d, in all other cases, the participation of an independent party is mandatory.
Only the manufacturer or authorized person on the territory of the Customs Union of a foreign manufacturer.
Registration of the declaration according to scheme 1d is carried out after the analysis of the product documentation, including the test report by the manufacturer.
Scheme 3d provides for testing of type samples in an accredited laboratory, only according to their results a declaration is registered.
Scheme 5e instead of testing products contains type studies, which are carried out in the same way as in the certification of a series of goods.
The 6d scheme is similar in its components to the 3d scheme, only it additionally includes certification of the quality management system.
13.12.2013Industry Certification
Certification of metalworking and woodworking equipment
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The high productivity of equipment setup makes production in small batches uneconomical. However, the production of large batches of the product leads to a significant reduction in throughput and the creation of high levels stocks. The decrease in equipment throughput occurs because several long production periods are required to pass larger batches through all manufacturing operations. The philosophy of "just in time" requires the reduction and, ultimately, the elimination of time to set up equipment. Investing in advanced manufacturing technologies, such as computer-controlled machine tools and flexible manufacturing systems, offers the opportunity to significantly reduce set-up times. If this time approaches zero, then the advantages of batch production are eliminated. Thus, the optimal batch size is equal to one unit of production. With one batch size, a product can seamlessly transition from one process to another without the need to store it in a warehouse and schedule the use of equipment to transfer the product to each next stage of production. Small batches of product produced, combined with a short production period, also allow the firm to respond more flexibly to short-term fluctuations in market demand, since production is not associated with a long planned lead time.
6.5. Procurement "just in time"
The just-in-time philosophy makes firms pay more attention to minimizing inventory levels through rational purchasing. This means that purchases are directly dependent on the use of purchased materials. Purchasing "just in time" involves the development of closer relationships with suppliers. More frequent deliveries of smaller quantities of materials are organized so that each delivery is only sufficient to meet the needs of production. Inventories are reduced to a minimum. Significant savings in inventory costs can also be realized by requiring suppliers to inspect materials prior to shipment and guarantee their quality.
This improvement in service is achieved by doing most of the business with fewer suppliers (those who can provide high quality and reliable delivery) and placing long-term purchase orders. In this regard, the supplier is provided with a sales market for an additional period and can plan to meet this demand.
Companies that buy raw materials on time have significantly reduced their inventory and work-in-progress costs. Other advantages of this method include significant savings in production space. A high volume of orders also means a reduction in the amount of technical (clerical) work, since it is easier to issue long-term general orders to several suppliers than individual purchase orders.
The effect of timely, reliable and frequent deliveries is that the need to maintain stocks of raw materials is largely eliminated. Moreover, the issuance of long-term general purchase orders leads to a large reduction in the cost of order fulfillment, which sharply reduces the optimal order size. Formula optimal size order is applied in these conditions in accordance with the principles of "just in time". those. it is necessary to make more frequent purchases of smaller volumes.
PART I. DETERMINING THE OPTIMAL LOOT SIZE FOR REPLENISHMENT
Lot size
The batch size is determined from the condition of the minimum of the total average annual costs of logistics.
Accountable costs
Delivery costs
Delivery costs = cost of goods + order value + transport costs + registration costs.
where: A - fixed costs(cost of the batch order);
C - batch size (number of units of purchased goods;
C(Q) - variable costs supplies.
Storage costs
Storage costs = insurance + taxes + spoilage + petty theft + cost of running a warehouse + hidden losses (capital does not work)
Storage costs (C xp) are very difficult to accurately account for. Usually they are estimated by an approximate formula:
where: i - coefficient of proportionality (generally: 0 Average cost of goods delivery; x - available stock of goods in the warehouse. Storage costs for one year (C 1 xp) can be calculated using the formula: The value of the integral in the above formula corresponds to the shaded area in Figure 1 below. Rice. 1. Storage costs In this article: The famous cosmetic brand L`Oreal Paris solemnly celebrated its 100th anniversary in June 2010. For such a long time of its existence, various products manufactured by this brand have managed not only to win recognition and popularity around the world, but also to maintain a dominant position in the cosmetic market. To meet the needs and desires of each of its customers, L`Oreal produces products designed for different ages and skin types. So, today this brand produces the following series of anti-wrinkle creams: Loreal Derma Genesis, Loreal Revitalift and Loreal Code of Youth. Consider what features each Loreal anti-wrinkle cream has, and thanks to which it helps to get rid of these extremely unpleasant wrinkles on the face. It is generally accepted that healthy young skin retains moisture and does not need additional hydration, because its cells produce hyaluronic acid in sufficient quantities. Over time, the skin gradually begins to fade and subsequently dry out. In order to prevent such a destructive process, the Derma Genesis series was developed. According to dermatological studies, the action of hyaluronic acid, which is part of the product, is activated when interacting with individual components, such as Pro-Xylan, which took seven years to study and create by leading scientists of the company. This substance was patented by the L`Oreal laboratory and included in the Derma Genesis series. Under the influence of Pro-Xylan, hyaluronic acid molecules can be fixed on the skin. In addition, this component has a stimulating effect on the creation of elastin fibers and collagen production. Products of the Derma Genesis series are recommended for use by owners of mature skin prone to dryness. After a few weeks of using the cream, the skin will acquire a radiant, healthy look, become smooth and elastic. Among other things, the cosmetics of the designated line effectively provide the skin with long-term hydration. The Derma Genesis series is intended for facial care for women over 25 years of age. All products are available in bottles of various capacities with a dispenser that prevents re-air intake. This property protects cosmetic products from oxidation, thereby ensuring their long-term preservation. So, the Derma Genesis series consists of: The best effect can be achieved if you use L'Oreal Anti-Wrinkle Cream regularly! Revitalift, unlike many other cosmetic lines aimed at combating wrinkles on the skin of the face, is a therapeutic series. The product has a double effect: it makes the skin supple and smoothes wrinkles. The secret of the effectiveness of the Revitalift series lies in the unique complexes of substances patented by L'oreal laboratories: It is recommended to use cosmetic products of the Revitalift series for skin care, only for women over 40 years old. Starting from this age, elastin fibers become much smaller and their network is significantly shredded. The skin loses its former firmness and elasticity, wrinkles on it become more and more pronounced. Cosmetic series Revitalift is represented by the following means: The popular company L'Oreal has presented to the whole world a real cosmetic bestseller - a series of skin care products called "Code of Youth". This line is the result of a decade of collaboration between the Saint-Louis clinic in Paris and the L'Oreal development department, who tried to find out how age affects the condition of the skin at the gene level. Mature and young skin react to external stimuli in different ways, and the rate of cell recovery varies significantly (30 times). In an effort to close this gap and make mature skin regenerate faster, experts have studied about 4,000 genes and were able to identify those that can help fight aging. Scientists have found that the youth of each person is embedded in his genes and directly depends on the production of individual proteins, which subsequently ceases over time. The main task is to force the cells to continue to produce these proteins in order to delay the aging process as much as possible. In order to solve this problem, special substances have been developed that are able to resume the activity of individual genes and, as a result, enhance the synthesis of proteins characteristic of young skin. These substances were the basis of the formula of the cream "Code of Youth", which allows women to look flawless and prolong youth as much as possible. The Code of Youth series is based on the latest Pro-Gen technology. It is a complex obtained by fermentation of bifidobacteria, which stimulates independent cellular repair and renewal characteristic of young skin. In addition, all products of this series include adenosine, which prevents cell aging. Cosmetic series "Code of Youth" is represented by a day cream, a rejuvenating concentrate and a cream for the skin around the eyes, which successfully cope with signs of fatigue, dull complexion and, of course, wrinkles. All products are distinguished by an unusually light texture and an indescribable floral-fruity aroma, the notes of which are revealed gradually, as if in a real perfume composition. So, the series includes:
Anti-aging creams from the world-famous L`Oreal Paris company are an excellent tool to help get rid of the signs of skin aging. Made according to special standards and technologies, they really allow you to effectively overcome wrinkles on the face, noticeably rejuvenate the skin and transform its condition.Loreal "Derma Genesis"
Series products
Loreal "Revitalift"
Series products
Loreal "Code of Youth"
Series products
