Problems and countermeasures of biopharmaceutical equipment management
時間：2021/7/5 9:58:18
Biopharmaceutical equipment due to the particularity of biological products, the bidding and procurement management of its production equipment will have a direct and vital impact on the quality and efficiency of pharmaceutical production. GMP, WHO, and FDA all have clear requirements for the procurement of biological products production equipment, but there are still problems in actual procuremen
Biopharmaceutical equipment due to the particularity of biological products, the bidding and procurement management of its production equipment will have a direct and vital impact on the quality and efficiency of pharmaceutical production. GMP, WHO, and FDA all have clear requirements for the procurement of biological products production equipment, but there are still problems in actual procurement such as non-compliance of procurement organization methods, low procurement efficiency and even procurement failure. This article summarizes the main problems existing in the equipment procurement of biopharmaceutical companies, and proposes solutions.
1. Problems existing in equipment procurement by biological products companies
(1) The procurement organization method is not compliant
Biological products equipment can be roughly divided into packaging, filling, freeze-drying, light inspection, biological reaction culture, filtration and purification, sterilization, tanks, centrifugation, process water, and experimental testing. Class etc. Most of these equipment have high monomer value (such as production-level filling, freeze-drying, packaging, light inspection, and biological reaction culture, each with a single value of more than 2 million yuan), and all purchasers use state-owned funds Investment or state-owned capital investment occupies a controlling or dominant position, and in accordance with the "Bidding and Bidding Law", an open bidding organization shall be adopted. If the purchaser plans to purchase mechanical and electrical products outside of China’s customs and plans to invite potential bidders to participate in the global scope, according to the "Mechanical and Electrical Products International Bidding Implementation Measures", international public bidding shall be adopted for procurement.
In actual procurement, there is often a problem that the purchaser does not have enough understanding of the national tendering and bidding laws and regulations, or because of the imperfect bidding system of the enterprise, the tight procurement time, or the subjective factors of the purchaser, the problem of non-compliance of the procurement organization method occurs. For projects that should be open for bidding, after the project is split, the company will purchase targeted purchases, invite specific suppliers to directly negotiate prices, and directly sign purchase contracts with suppliers.
(2) Low procurement efficiency or even procurement failure
There are many reasons for low procurement efficiency and even procurement failure. Such as unclear description of user requirements documents, improper use of bid evaluation methods, deviation of bidder's understanding of bidding documents, and bidders do not pay attention to or deliberately resort to fraud.
1. Unclear description of user requirements document
User requirements documents are required written materials provided by the purchaser to the bidder, mainly the purchaser's technical and commercial requirements for the purchased equipment. The more detailed the user requirements document description, the more the procurement results meet the procurement requirements. That is to say, the bidder can know which model product can meet the actual needs of users by analyzing the bidding documents. Biological products companies have a user requirements document preparation process. The requirements department proposes equipment technical indicators, and the quality, engineering, procurement and other related departments supplement other requirements. After the requirements are summarized and reviewed, the final user requirements document is formed. Although the process is perfect, because each department is in their own hands, they cannot consider the overall situation, let alone describe the requirements from the perspective of open bidding, which brings great trouble to the procurement. For example, the technical parameters are completely compiled with reference to the supplier’s product descriptions, causing the bidders to question or the entire bidding is only one bidder participating; the substantive technical terms are too simple and the bidders of all technical levels meet the needs, or too many substantive terms cause all None of the bidders met; quantifiable indicators were not marked with specific data ranges, which caused the bidders to be unable to accurately judge the actual needs of the purchaser, and the bidding equipment configuration was too high or not satisfied; the descriptions before and after the documents were inconsistent, causing the bidders to be unable to provide Compliant equipment.
2. Improper selection of bid evaluation methods
Article 29 of the "Interim Regulations on Bid Evaluation Committee and Bid Evaluation Methods" (Order No. 12 of the Seven Ministries and Commissions) clearly stipulates that "Bid evaluation methods include the evaluated low bid price method, comprehensive evaluation method, or those permitted by laws and administrative regulations. Other bid evaluation methods.” The experimental testing equipment in biological equipment is relatively technically versatile, the market is mature, and the competition is fierce. If the purchaser has no special requirements, this type of equipment can generally be evaluated by the evaluated low bid price method. Mark. That is, on the premise that the bidding documents of the bidder meet the bidding documents in terms of technology and business, the bidder with a low price is recommended to win the bid. However, equipment such as filling, packaging, bioreactors, and water systems are customized equipment. Purchasers have higher requirements for the performance and technology of such equipment. Different technical differences and design differences will have a greater impact on purchasers, so this type of equipment The equipment should adopt a comprehensive evaluation method for bid evaluation. However, in actual procurement, some purchasers used low-price bid evaluation methods in order to reflect their work performance, or to emphasize the saving of funds too much. Some even guide bid evaluation experts in bid evaluation, ignoring "can meet the substantive requirements of the bidding documents", etc., and all use price as the criterion for measuring bidders. The misuse or even abuse of bid evaluation methods by purchasers will inevitably cause greater troubles in the procurement work, and in serious cases will cause procurement failures and cause greater losses to the enterprise.
The more complex equipment in biological products, such as bioreactors, distribution systems, etc., due to complex processes, high professional design requirements, and more rigorous descriptions of technical terms. When the technical requirements of the purchaser involve design plan requirements, degree of automation, transformation effects, workshop environment and layout, processing of connection parts, verification documents, etc., if the words are not rigorous enough, and the preliminary technical communication work is not sufficient, the same The terms are analyzed from different angles and may have different meanings. These often cause the difference between the bidder’s requirements and the bidder’s response, that is, the bidder can meet according to his own understanding, but in fact, according to the bidder’s idea, it cannot be satisfied or the satisfaction is flawed. If these problems are not discovered during the bid evaluation process, and the successful bidder is determined, the actual implementation of the contract will inevitably cause disputes between the two parties, and improper handling will have a greater impact on the equipment supply.
Biopharmaceutical equipment
4. The bidder does not value or deliberately falsify
The bidder is a legal person or other organization that responds to the bidding and participates in the bidding competition, and shall have the ability to undertake the bidding project. Bidders shall prepare bidding documents in accordance with the requirements of the bidding documents, and respond to the substantive requirements and conditions put forward in the bidding documents. Do not bid lower than the cost price, nor allow others to bid in the name of others or resort to fraud in other ways to defraud the winning bid.
The bidder’s inattention to the bidding work is mainly reflected in the large problems in the format of the bidding documents or the basic business information that does not meet the requirements of the bidding documents. If the credit certification documents are not stamped, the international public bidding projects are not signed page by page as required, the technical terms of the bidding documents are copied and pasted, the quality certification system documents are expired, the manufacturer’s authorization documents are missing, the bid documents are delivered overdue, and the bidding is not followed. Documents require sealing, etc. The embankment of a thousand miles was destroyed by the ant colony. Because of these seemingly simple problems, the bidders often failed to pass the conformity inspection stage of the bid evaluation. In order to win the bid, some bidders resorted to falsification. For example, the commercial clauses and technical clause deviation tables of the bidding documents are expressed as satisfaction regardless of whether they are satisfied. The bidding technical response adopts vague description methods, fabricating false contracts, enterprise qualifications, etc. . These bad behaviors will directly affect the effectiveness of procurement.
Second, explore solutions
(1) Strengthen the study of laws and regulations on bidding and bidding
Buyers should strengthen bidding laws and regulations such as the "Bidding and Bidding Law", "Government Procurement Law", "Implementation Regulations of the Bidding and Bidding Law", "Measures for the Bidding and Bidding of Engineering Construction Project Goods", "Measures for the Implementation of International Bidding and Bidding for Mechanical and Electrical Products", and "Projects that must be tendered." Learn to learn from the nature of the project, the nature of funds, and scale standards to accurately grasp which are the projects that must be tendered, and which are the projects that can not be tendered, and strictly follow the implementation.
While complying with national laws and regulations, the purchaser should also formulate a corresponding procurement management system based on the actual situation of the enterprise, which covers all procurement operations, especially for equipment other than the state’s regulations that must be publicly tendered, in order to ensure fair and just procurement. On the basis of this, the system is complete, the process is perfect, and the execution is strong.
(2) Prepare bidding documents scientifically and rigorously
Some purchasers think that they are the first party of the purchase and hold the initiative. It is not important whether the tender documents are prepared rigorously and well. As long as the final supplier company is strong and the product quality is excellent, in the execution of the contract, the equipment can be provided in full accordance with the requirements of the purchaser. In fact, the bidding document is an invitation for an offer, the bidding document is the offer, and the bid-winning notice is a promise. All three have legal effect. The determination of the successful bidder is based on the response of the bidding documents to the bidding documents, that is to say, the degree of detail of the bidding documents plays a decisive role in the procurement results. Therefore, purchasers need to change their concepts and strive to be accurate, clear and perfect in the preparation of bidding documents.
1. Clarify the purpose of purchase
It is necessary to clarify the purpose of equipment procurement, and determine the positioning of the equipment based on the equipment's product layout for biological products enterprises, the versatility of the equipment in the enterprise, and the purchaser's funds.
2. Jointly complete the requirements preparation
Organizational use, equipment management, engineering technology, quality management, procurement and other departments jointly complete the preparation of user requirements. The user department proposes detailed technical parameters based on the plan design, process configuration, functional requirements, and performance indicators. The other departments deal with project management, project implementation plans, quality assurance systems, safety systems, public systems, installation and commissioning, and after-sales maintenance according to corresponding responsibilities. And so on. The summarized user requirements must be discussed and reviewed by all participating departments to ensure that the document wording is clear and clear, does not cause ambiguity, and the content is set reasonably to meet the company's procurement needs. In addition, it should also be noted that the important clauses have no inclination or discriminatory opinions, do not hinder or restrict competition among bidders, and there is no overlap or inconsistency in the overlapping parts.
3. Scientifically formulate bid evaluation methods
The bid evaluation method has a guiding effect on the bidder's bid quotation strategy and has a decisive effect on the bidding result. Due to the complex technology of large-scale biological equipment, comprehensive scoring methods are often used. The purchaser should set the scoring factors, scores and specific scoring standards reasonably according to the characteristics of the equipment and the focus of the enterprise. The setting of terms should be as detailed, comprehensive and targeted as possible; the scoring standards should be as objective and fair as possible to reduce the influence of human factors on the bid winning results; to a large extent, the bidder's technical ability, management ability and actual equipment performance should be reflected.
(3) Pay attention to the early technical exchange work
With the rapid development of the biological products industry, more and more new materials and high-tech technologies are applied to the equipment, and the operability, stability, and automation of the equipment are continuously improved. These will, to a certain extent, affect the scientific research and production of biological products companies. Provided convenience. Therefore, before purchasing equipment, biological products companies must have a detailed understanding of the current technical level of the equipment. First of all, we must attach great importance to technical exchanges. The procurement department of the company is very familiar with the technology and supply of different equipment through market research, participation in pharmaceutical exhibitions, supplier recommendations and other channels. You can select some of them with high reputation, excellent product quality, and service. Good suppliers conduct technical exchanges. Through technical exchanges, establish an information channel between the purchaser and the supplier, so that the supplier can clarify the purchaser's purchase purpose, and technically introduce the purchaser to the applicable equipment. Reduce suppliers' misunderstanding of bidding documents during the bidding stage, and reduce low-level errors in the preparation of bidding documents. Make purchasers understand the current new technology and provide more options for equipment selection. Understand the characteristics and differences of the technical level of each supplier, master the information of different equipment manufacturing cycles, and provide a basis for the compilation of user demand documents.
In order to ensure the quality of technical communication, the purchaser should formulate a communication plan before technical communication, and clarify the participants and specific responsibilities. Highlight the key points in the communication and record the communication process in detail. After the communication is over, a detailed communication report shall be formed, and the participating personnel shall review and make specific suggestions. During the entire communication process, we must strictly abide by the discipline of technical exchanges, and ensure that no biased opinions are revealed during the exchange, which will affect the subsequent bidding and procurement work.
1. Problems existing in equipment procurement by biological products companies
(1) The procurement organization method is not compliant
Biological products equipment can be roughly divided into packaging, filling, freeze-drying, light inspection, biological reaction culture, filtration and purification, sterilization, tanks, centrifugation, process water, and experimental testing. Class etc. Most of these equipment have high monomer value (such as production-level filling, freeze-drying, packaging, light inspection, and biological reaction culture, each with a single value of more than 2 million yuan), and all purchasers use state-owned funds Investment or state-owned capital investment occupies a controlling or dominant position, and in accordance with the "Bidding and Bidding Law", an open bidding organization shall be adopted. If the purchaser plans to purchase mechanical and electrical products outside of China’s customs and plans to invite potential bidders to participate in the global scope, according to the "Mechanical and Electrical Products International Bidding Implementation Measures", international public bidding shall be adopted for procurement.
In actual procurement, there is often a problem that the purchaser does not have enough understanding of the national tendering and bidding laws and regulations, or because of the imperfect bidding system of the enterprise, the tight procurement time, or the subjective factors of the purchaser, the problem of non-compliance of the procurement organization method occurs. For projects that should be open for bidding, after the project is split, the company will purchase targeted purchases, invite specific suppliers to directly negotiate prices, and directly sign purchase contracts with suppliers.
(2) Low procurement efficiency or even procurement failure
There are many reasons for low procurement efficiency and even procurement failure. Such as unclear description of user requirements documents, improper use of bid evaluation methods, deviation of bidder's understanding of bidding documents, and bidders do not pay attention to or deliberately resort to fraud.
1. Unclear description of user requirements document
User requirements documents are required written materials provided by the purchaser to the bidder, mainly the purchaser's technical and commercial requirements for the purchased equipment. The more detailed the user requirements document description, the more the procurement results meet the procurement requirements. That is to say, the bidder can know which model product can meet the actual needs of users by analyzing the bidding documents. Biological products companies have a user requirements document preparation process. The requirements department proposes equipment technical indicators, and the quality, engineering, procurement and other related departments supplement other requirements. After the requirements are summarized and reviewed, the final user requirements document is formed. Although the process is perfect, because each department is in their own hands, they cannot consider the overall situation, let alone describe the requirements from the perspective of open bidding, which brings great trouble to the procurement. For example, the technical parameters are completely compiled with reference to the supplier’s product descriptions, causing the bidders to question or the entire bidding is only one bidder participating; the substantive technical terms are too simple and the bidders of all technical levels meet the needs, or too many substantive terms cause all None of the bidders met; quantifiable indicators were not marked with specific data ranges, which caused the bidders to be unable to accurately judge the actual needs of the purchaser, and the bidding equipment configuration was too high or not satisfied; the descriptions before and after the documents were inconsistent, causing the bidders to be unable to provide Compliant equipment.
2. Improper selection of bid evaluation methods
Article 29 of the "Interim Regulations on Bid Evaluation Committee and Bid Evaluation Methods" (Order No. 12 of the Seven Ministries and Commissions) clearly stipulates that "Bid evaluation methods include the evaluated low bid price method, comprehensive evaluation method, or those permitted by laws and administrative regulations. Other bid evaluation methods.” The experimental testing equipment in biological equipment is relatively technically versatile, the market is mature, and the competition is fierce. If the purchaser has no special requirements, this type of equipment can generally be evaluated by the evaluated low bid price method. Mark. That is, on the premise that the bidding documents of the bidder meet the bidding documents in terms of technology and business, the bidder with a low price is recommended to win the bid. However, equipment such as filling, packaging, bioreactors, and water systems are customized equipment. Purchasers have higher requirements for the performance and technology of such equipment. Different technical differences and design differences will have a greater impact on purchasers, so this type of equipment The equipment should adopt a comprehensive evaluation method for bid evaluation. However, in actual procurement, some purchasers used low-price bid evaluation methods in order to reflect their work performance, or to emphasize the saving of funds too much. Some even guide bid evaluation experts in bid evaluation, ignoring "can meet the substantive requirements of the bidding documents", etc., and all use price as the criterion for measuring bidders. The misuse or even abuse of bid evaluation methods by purchasers will inevitably cause greater troubles in the procurement work, and in serious cases will cause procurement failures and cause greater losses to the enterprise.
The more complex equipment in biological products, such as bioreactors, distribution systems, etc., due to complex processes, high professional design requirements, and more rigorous descriptions of technical terms. When the technical requirements of the purchaser involve design plan requirements, degree of automation, transformation effects, workshop environment and layout, processing of connection parts, verification documents, etc., if the words are not rigorous enough, and the preliminary technical communication work is not sufficient, the same The terms are analyzed from different angles and may have different meanings. These often cause the difference between the bidder’s requirements and the bidder’s response, that is, the bidder can meet according to his own understanding, but in fact, according to the bidder’s idea, it cannot be satisfied or the satisfaction is flawed. If these problems are not discovered during the bid evaluation process, and the successful bidder is determined, the actual implementation of the contract will inevitably cause disputes between the two parties, and improper handling will have a greater impact on the equipment supply.
Biopharmaceutical equipment
4. The bidder does not value or deliberately falsify
The bidder is a legal person or other organization that responds to the bidding and participates in the bidding competition, and shall have the ability to undertake the bidding project. Bidders shall prepare bidding documents in accordance with the requirements of the bidding documents, and respond to the substantive requirements and conditions put forward in the bidding documents. Do not bid lower than the cost price, nor allow others to bid in the name of others or resort to fraud in other ways to defraud the winning bid.
The bidder’s inattention to the bidding work is mainly reflected in the large problems in the format of the bidding documents or the basic business information that does not meet the requirements of the bidding documents. If the credit certification documents are not stamped, the international public bidding projects are not signed page by page as required, the technical terms of the bidding documents are copied and pasted, the quality certification system documents are expired, the manufacturer’s authorization documents are missing, the bid documents are delivered overdue, and the bidding is not followed. Documents require sealing, etc. The embankment of a thousand miles was destroyed by the ant colony. Because of these seemingly simple problems, the bidders often failed to pass the conformity inspection stage of the bid evaluation. In order to win the bid, some bidders resorted to falsification. For example, the commercial clauses and technical clause deviation tables of the bidding documents are expressed as satisfaction regardless of whether they are satisfied. The bidding technical response adopts vague description methods, fabricating false contracts, enterprise qualifications, etc. . These bad behaviors will directly affect the effectiveness of procurement.
Second, explore solutions
(1) Strengthen the study of laws and regulations on bidding and bidding
Buyers should strengthen bidding laws and regulations such as the "Bidding and Bidding Law", "Government Procurement Law", "Implementation Regulations of the Bidding and Bidding Law", "Measures for the Bidding and Bidding of Engineering Construction Project Goods", "Measures for the Implementation of International Bidding and Bidding for Mechanical and Electrical Products", and "Projects that must be tendered." Learn to learn from the nature of the project, the nature of funds, and scale standards to accurately grasp which are the projects that must be tendered, and which are the projects that can not be tendered, and strictly follow the implementation.
While complying with national laws and regulations, the purchaser should also formulate a corresponding procurement management system based on the actual situation of the enterprise, which covers all procurement operations, especially for equipment other than the state’s regulations that must be publicly tendered, in order to ensure fair and just procurement. On the basis of this, the system is complete, the process is perfect, and the execution is strong.
(2) Prepare bidding documents scientifically and rigorously
Some purchasers think that they are the first party of the purchase and hold the initiative. It is not important whether the tender documents are prepared rigorously and well. As long as the final supplier company is strong and the product quality is excellent, in the execution of the contract, the equipment can be provided in full accordance with the requirements of the purchaser. In fact, the bidding document is an invitation for an offer, the bidding document is the offer, and the bid-winning notice is a promise. All three have legal effect. The determination of the successful bidder is based on the response of the bidding documents to the bidding documents, that is to say, the degree of detail of the bidding documents plays a decisive role in the procurement results. Therefore, purchasers need to change their concepts and strive to be accurate, clear and perfect in the preparation of bidding documents.
1. Clarify the purpose of purchase
It is necessary to clarify the purpose of equipment procurement, and determine the positioning of the equipment based on the equipment's product layout for biological products enterprises, the versatility of the equipment in the enterprise, and the purchaser's funds.
2. Jointly complete the requirements preparation
Organizational use, equipment management, engineering technology, quality management, procurement and other departments jointly complete the preparation of user requirements. The user department proposes detailed technical parameters based on the plan design, process configuration, functional requirements, and performance indicators. The other departments deal with project management, project implementation plans, quality assurance systems, safety systems, public systems, installation and commissioning, and after-sales maintenance according to corresponding responsibilities. And so on. The summarized user requirements must be discussed and reviewed by all participating departments to ensure that the document wording is clear and clear, does not cause ambiguity, and the content is set reasonably to meet the company's procurement needs. In addition, it should also be noted that the important clauses have no inclination or discriminatory opinions, do not hinder or restrict competition among bidders, and there is no overlap or inconsistency in the overlapping parts.
3. Scientifically formulate bid evaluation methods
The bid evaluation method has a guiding effect on the bidder's bid quotation strategy and has a decisive effect on the bidding result. Due to the complex technology of large-scale biological equipment, comprehensive scoring methods are often used. The purchaser should set the scoring factors, scores and specific scoring standards reasonably according to the characteristics of the equipment and the focus of the enterprise. The setting of terms should be as detailed, comprehensive and targeted as possible; the scoring standards should be as objective and fair as possible to reduce the influence of human factors on the bid winning results; to a large extent, the bidder's technical ability, management ability and actual equipment performance should be reflected.
(3) Pay attention to the early technical exchange work
With the rapid development of the biological products industry, more and more new materials and high-tech technologies are applied to the equipment, and the operability, stability, and automation of the equipment are continuously improved. These will, to a certain extent, affect the scientific research and production of biological products companies. Provided convenience. Therefore, before purchasing equipment, biological products companies must have a detailed understanding of the current technical level of the equipment. First of all, we must attach great importance to technical exchanges. The procurement department of the company is very familiar with the technology and supply of different equipment through market research, participation in pharmaceutical exhibitions, supplier recommendations and other channels. You can select some of them with high reputation, excellent product quality, and service. Good suppliers conduct technical exchanges. Through technical exchanges, establish an information channel between the purchaser and the supplier, so that the supplier can clarify the purchaser's purchase purpose, and technically introduce the purchaser to the applicable equipment. Reduce suppliers' misunderstanding of bidding documents during the bidding stage, and reduce low-level errors in the preparation of bidding documents. Make purchasers understand the current new technology and provide more options for equipment selection. Understand the characteristics and differences of the technical level of each supplier, master the information of different equipment manufacturing cycles, and provide a basis for the compilation of user demand documents.
In order to ensure the quality of technical communication, the purchaser should formulate a communication plan before technical communication, and clarify the participants and specific responsibilities. Highlight the key points in the communication and record the communication process in detail. After the communication is over, a detailed communication report shall be formed, and the participating personnel shall review and make specific suggestions. During the entire communication process, we must strictly abide by the discipline of technical exchanges, and ensure that no biased opinions are revealed during the exchange, which will affect the subsequent bidding and procurement work.
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