All products of this series are one. Pharmaceutical terminology - marginal notes (3)

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 want to change it, you must make official changes and provide convincing evidence of such a possibility. A package of technological documentation (manufacturing recipe, technological instructions and packaging instructions) is 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 to 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 a key indicator of the quality of the medicinal product. The uniformity of the dose of the drug affects the reliability of the results of ongoing clinical trials, 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 contain included the test "Uniformity of dosage units" in accordance with section 2.9.40 of the European Pharmacopoeia, which involves the assessment of the homogeneity of each individual part of the dosage form.

At the same time, the problem lies in the fact that GMP requirements do not contain clear definitions and specific provisions on the issue of batch formation and determination of its acceptable size, leaving this to the mercy (responsibility) of the drug manufacturer and the state drug registration authority. 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 technological equipment used, 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 assessment results in the annual Drug Quality Review, unconscious (or maybe 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 suitability 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 unambiguous, it requires detailed consideration and assessment based on the 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 effect on the uniformity of the dosage form.

Findings: The homogeneity of a series of GLS 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 manufacture 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 batch size of the FPP in this example is 600,000 p/o tablets (based on the uniformity 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 the general definition of a series of drugs? Is it one coating operation in a set of manufacturing 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 coating 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 its 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 for a protective purpose (protecting the dosage form from the external environment, or masking the taste and / or color characteristics), it does not affect the uniformity of the drug, but if the coating 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 series of 200,000 film-coated tablets, with any type of coating, can really be considered a priority option - because from the point of view 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 justified, 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 packaging lines are installed in the same production area, have identical packaging units, it may be quite reasonable to pack a series of FLS (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 decision is always related to 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 sources of variability (variation) of uniformity, have confirmed information about the presence and degree 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 - this is the collection and evaluation of data that provides scientific evidence that the technological process is capable of consistently producing a quality drug. 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 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 of inventory. The decrease in equipment throughput occurs because several long production periods are required to pass larger batches through all production 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. Purchasing "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 holding 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 less 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. The optimal order size formula 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 (the cost of ordering a batch);

C - batch size (number of units of purchased goods;

С(Q) - variable costs of delivery.

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

The products are organized according to various criteria and approaches. In order to optimize their production cycles and increase financial results, enterprises are very thoughtful in the way they manufacture their products. There are several generally accepted ways of producing products.

Serial production is a special form of organization of the production cycle, based on certain technological, economic features, specialization, as well as the range of products of the enterprise.

Factors of production

The type of production is influenced by a number of its characteristics and features. These are technical, organizational and economic indicators of the enterprise. They are determined by the composition and breadth of the range, the volume of output of finished products, as well as its stability and regularity of release.

Depending on the level of specialization and concentration, single, serial and mass production are distinguished. They are determined by a number of factors. First of all, the type of production is affected by the volume of output and its nomenclature. When organizing the production cycle, the degree of constancy of the list of products being created, as well as the workload of jobs, are taken into account.

One or another production process is applicable to the entire enterprise, its sections or even individual workplaces. Assigning a company to a certain category is rather conditional.

Production types

The main types of production (single, serial, mass) have a number of characteristic features.

Single production is characterized by a small volume of production of identical products. Their repair or re-release is not provided.

In serial production, it is produced in batches. Moreover, they are produced with a certain frequency. Distinguish between small-scale, large-scale and medium-scale type of production.

Mass production is characterized by the largest scale. Products in this case are manufactured continuously and in large quantities. This takes quite a lot of time.

The main properties of serial production

It is the most common type of production organization in many industries. Products in this case are characterized by structural uniformity. They are produced in series of small, medium or large sizes. Intervals are repeated with a certain frequency. During the production cycle, some time is required for the production of products, as well as breaks when the equipment is at rest.

The concept of "series" should be understood as a certain number of the same type of goods that are created by a single enterprise.

The range of goods in this type of production is quite large. This indicator looks more diverse only with a single approach to the organization of the release of goods. A certain part of the products has similarities in terms of technological and structural features.

Features and Benefits

It has a number of characteristic features. One of them is the repeatability and periodicity of the manufacturing process of finished products. This makes the production cycle rhythmic.

The release of goods is carried out in large or relatively large volumes. This makes it possible to unify the products being created, as well as the technological processes themselves. At the same time, products can be manufactured according to standards and regulations. This makes it possible to use them in constructive rows in large quantities. With this approach, their cost is reduced.

In addition to improving the quality of finished products, as well as reducing its cost, organizations have the opportunity to purchase special equipment, sharpened for the production of standard parts and assemblies. The performance also increases in this case.

Main features

Characteristics of mass production allows you to highlight the main features of this method of organizing the release of goods. These include production in series with a wide range of parts and assemblies of the same type. Production activity in this case is decentralized by workshops, departments, etc. Their specialization increases.

Production of products is carried out both on the basis of orders and previously unknown customers. The workers have an average skill level. Manual labor is characterized by small volumes.

Production cycles are short. The technological process is typified. In this case, high-tech equipment is used. Quality control is automated. Statistical methods are applied to control compliance with product standards.

disadvantages

Serial production is system that has a number of advantages. But also this approach to the organization of output has some disadvantages. First of all, it should be noted the long cycle time with irregular operation of the equipment.

Frequent changeovers, maintenance of equipment, machine tools require a significant investment of time. In this case, non-manufacturing costs increase. There are long breaks in production. They arise as a result of preparatory work for the manufacture of goods, parts.

With the wrong approach to the organization of the production process, the cost of products may increase, as well as turnover may decrease. At the same time, labor productivity may also decrease. Therefore, the process of organizing the serial production of goods must be taken seriously, a number of calculations and planning must be carried out.

Subtypes

Serial production is conditionally divided into small, medium and large production. This division is conditional. This is due to the presence of some characteristic features of the single and mass production principle in some subtypes.

Some of the features that mass and batch production, are successfully combined in a large-scale subcategory. At the same time, the series have a large scale. It takes a lot of time to make them. Breaks between games are small and rare.

If the batches are small, some features of a single method of manufacturing goods are determined in such batches. This approach is often used to create a small batch of special-order parts. And in recent years, this approach has been significantly improved. The use of computer technology makes it possible to reduce the cost of working time, to produce several different types of parts on the same production line.

calendar distribution

Rhythm, efficiency of production of batches of finished products allows you to organize a calendar development. Mass production requires distribution over several stages.

If parts, assemblies or blanks are planned to be produced for a whole year, they are distributed by months. After that, in the planning period, the fund of time is determined, during which the equipment will work to produce the required nomenclature.

The rest of the time is also estimated. It is used to create other goods that are provided for by the production program. Such products are distributed in accordance with calendar plans according to the terms of contracts with suppliers and customers.

Create sets

They can produce whole sets of products, the production time of which is in close time intervals. These types of parts, assemblies are combined. Such sets allow you to load the equipment relatively evenly. Thus, the number of product combinations that are fixed in individual months is reduced.

A set of certain details is assigned to the selected segment of the calendar period. The company is interested in the periodic repetition of such combinations throughout the year. This allows you to establish a rhythmic release of products.

The annual program for the range and volume of production of finished goods must be fully completed within a calendar period. Moreover, when creating sets of products, various combinations of manufacturing parts are calculated. This makes it possible to check the capacity utilization.

Operational and production planning system

Serial production is a rather complex type of organization, in which several detail-operations are assigned to one workplace. Therefore, several systems are used for. These include the development of future production for cycle sets, for backlogs, as well as for complete numbers. Plans are created based on a continuous production process.

To determine future cycle sets based on inter-shop indicators, the source documents are the plan for the manufacture of goods for the year, as well as information on the composition of the set. They list all the parts, blanks that are included in the composition. The planning department takes into account the calendar standards for each unit of production and the entire set.

This approach allows the company to properly organize mass production, increase the productivity of equipment and labor resources. Correction of planned cycles during the formation of sets provides an opportunity to choose the most profitable option for creating finished goods.

Benefits of scheduling cycle sets

It cannot be effectively carried out without planning for the shops and backlogs of the enterprise. Analysts calculate the planned launch dates for the cycle set. This work is carried out for each shop of the company. Planning is carried out on the basis of the previously established deadlines and the order in which kits are submitted for their assembly. In this case, the standard indicator of the duration of each cycle is taken into account. The whole system must function smoothly, fulfilling the tasks of the enterprise.

Planning provides a company with a number of benefits. The production of goods takes place rhythmically, allowing you to reduce the downtime of equipment and the aging of blanks, components and parts.

Backlog planning

The most flexible in the planning process is the backlog program development system. First, a fundamental level is determined for calculating the backlog for parts, assemblies in each workshop. When organizing the production process, the task is to maintain the level of production of goods by structural units in accordance with the calculated level. The volume of planned targets for each product is determined in days or five days relative to the final output.

It is economically advantageous to reduce the adjustment operations of structures, since the stability of the dimensions of the parts makes it possible to reduce the specific weight of each manual operation of workers. They perform several specialized operations.

Development of group processes

Differs in variety and complexity of the organization. It includes machine-tool, machine-building enterprises. For medium and small-scale production, it is advisable to use the group planning method.

The essence of this approach involves the development and creation of an appropriate tooling base. All parts are divided into types. At the same time, their technological, structural similarities, as well as the same type of equipment used, are taken into account.

From each group, when planning, the most complex part is distinguished, in which structural elements similar to other products are determined. If it is not available, a complex unit of production is developed. According to it, equipment and machines are designed. This allows you to make any part of the group. This approach makes mass production cost-effective.

Serial production is the most common form of organizing the process of producing finished products. Knowing its features, as well as using the analytical service, it is able to increase the profitability of finished products and improve technological cycles.

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.

Loreal "Derma Genesis"

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.

Series products

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:

• Day cream and Day care SPF 15 for the face. Both products are represented by an emulsion with a silky texture and an unobtrusive floral aroma. They are suitable for the décolleté, face and neck. With regular use, the skin will become toned and smooth, the SP factor will protect it from ultraviolet rays, which are one of the main sources of early skin aging;
• Intensive night care. The formula of the cream is designed taking into account the peculiarities of the biological rhythm of the skin. Studies have found that at night, cells are restored much more actively than during the day;
• Concentrated serum. It is a water gel that is easily absorbed into the skin. In addition to hyaluronic acid, which saturates the skin with nutrients, the composition of the product also includes hydrophilic silicone that softens the skin. Serum is applied before using the cream, it is necessary for organizing the preliminary stage of anti-aging care;
• Cream-contour around the eyes. The cream is aimed at combating puffiness, dark circles under the eyes and fine wrinkles. The product is specially adapted for delicate and thin skin. Easily absorbed, the cream does not cause a feeling of heaviness.

The best effect can be achieved if you use L'Oreal Anti-Wrinkle Cream regularly!

Loreal "Revitalift"

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:

• Nanosomes with Pro-Retinol A - penetrating deep into each fold, this complex restores the ideal surface of the skin;
• Fibro-Elastil is a complex of substances that includes various vitamins necessary for the skin and restores the connection of the epidermis with the tissues responsible for skin elasticity.

Series products

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:

• Daily cream. Its formula is designed to combat the signs of skin aging by removing wrinkles. The skin will become more elastic after 8 days of use, and after 4 weeks the number of wrinkles will significantly decrease;
• Night cream. The tool effectively fights wrinkles on the face, returns the skin to its former elasticity, stimulates its regeneration and tightens the epidermis. The cream contains the Stimulift complex, which stimulates the production of substances that renew the skin from the inside, and Pro-Retinol A, which increases the resistance of the skin to adverse external influences and activates the regeneration of the epidermis. An important component of the cream is pro-retinol A, which, being an antioxidant, helps to heal the skin;

• Cream around the eyes. This product, enriched with elastin, smoothes wrinkles around the eyes and, by strengthening skin tissues, restores lost elasticity to the skin. After using the product, the skin around the eyes will become fresh, and the eye contour will be radiant;
• Serum Revitalift. It is an instant treatment with a high concentration of anti-aging active ingredients, thanks to which the serum successfully fights the top 10 signs of aging. In fact, this is a unique youth cocktail that combines hyaluronic acid, bifidobacterium biolysate, soy and yeast extracts;
• Cream for face and neck. The loss of elasticity is most pronounced on the neck and on the contours of the face: the contours of the face sag, and folds appear on the neck. This is because the skin produces fewer fibers with age and the bonds between them weaken. The cream was created specifically to tighten the neck and facial contours and smooth out the wrinkles on them;
• The Revitalift series also includes creams that give a double effect: it lifting gel and anti-wrinkle creams. Thus, one tool is able to carry out a facelift and smooth out wrinkles.

Loreal "Code of Youth"

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 ten-year 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 narrow 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.

Series products

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:

• Daily cream. The tool provides anti-aging care, smoothes wrinkles and gives the face freshness. With regular use of the cream, the skin regains the properties of its youth and becomes radiant, rested and smooth;
• Eye cream. The product has a smoothing effect on very delicate and sensitive skin in the eye area. The moisturizing formula included in the cream in tandem with Pro-Gen technology will help restore youthfulness to the skin;
• Rejuvenating concentrate. Highly effective serum will help create an instant tightening and rejuvenating effect. The tool restores the skin's ability to self-healing, in view of which it will look more beautiful and younger.

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.

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 batch:

1. On their own security justifications.
2. 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. Firstly, in addition to testing type samples, the manufacturer must necessarily conduct production control and provide an 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, when 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 all future products;
• analysis of technical documentation, testing of a product sample or critical components of a product.

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 an authorized person on the territory of the Customs Union of a foreign manufacturer can accept a declaration for serially supplied products.

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.

Industry Certification

Certification of metalworking and woodworking equipment

our clients

• "Ekolos" - suburban sewerage, autonomous sewerage. The company provides a full range of services in the field of wastewater treatment and pumping: selection, design, supply, installation, commissioning, maintenance of equipment.

• ILVE S.p.A. - Italian manufacturer of premium household appliances. The Italian factory Ilve has been known in the global household appliances market for over 30 years. Despite the relatively small age, the products of this manufacturer are the standard of high design and quality. Ilve appliances enhance the aesthetics of your kitchen interior while allowing you to create culinary masterpieces
  

• Cameron is a leading manufacturer and supplier of equipment for the oil and gas industry. The company sells, designs, manufactures, installs and services oil and gas equipment and works with major drilling and gas manufacturers, pipeline operators and other companies involved in the oil and gas production process.