Contract Manufacturing of Medicinal Products and Medical Devices

Legal support for contract manufacturing of medicinal products and medical devices

Taking into account the development of pharmaceuticals, interactions between entrepreneurs within the framework of contract manufacturing are becoming increasingly relevant, which is the production of products at the facilities of a partner company with full obligatory observance of all technological processes for the production of a medicinal product and in accordance with the quality standards adopted by the customer company. This approach in the production of medicines and medical devices allows you to quickly respond to the needs of patients.

For full-fledged interaction within the framework of contract manufacturing of medicinal products and medical devices, partner companies need to carry out a number of activities:

1. Find and negotiate with a manufacturing company.
2. Develop and sign a contract manufacturing agreement.
3. Prepare and sign a quality agreement.
4. Start production in compliance with the established quality of the medicinal product or medical device.

Contract manufacturing can significantly reduce the financial and time costs of the manufacturer of a drug or medical device for the formation of a technological production line, this is an important element of entrepreneurial pharmaceutical activity in modern realities. So, for example, the cycle of contract manufacturing of pharmaceutical products includes, among others, the following stages:

1. Production of a dosage form.
2. Packing and packaging of the medicinal product.
3. Registration of certification

At the same time, all manufactured products are manufactured in accordance with regulatory and technical documentation, as well as with the technical requirements of the customer.

Such interaction between contract manufacturing participants requires careful documentary and practical preparation, development of an interaction agreement taking into account all the specifics of the production of medicines or medical devices, execution of a quality agreement and other necessary documents. Legal support is a necessary condition for interaction between contract manufacturing partner companies, this is due to the obligatory observance of the entire technological process of manufacturing a medicine or medical device.

The terms and conditions of a contract manufacturing agreement, as a rule, depend on the country in which the participant in contract manufacturing operates, the legislation of this country, including, which governs the conclusion of such contracts. The contract manufacturing agreement must include the following sections:

1. Purpose and background.
2. Terms of the contract, terms of production, grounds for termination of the contract, the territory on which the contract manufacturing will be carried out.
3. Medicinal product or medical device to be manufactured, requirements for the manufacturing process.
4. Procurement of materials and payment terms.
5. Conditions for attracting third parties for production activities.
6. Dispute resolution, notice to parties, jurisdiction and arbitration.
7. Force majeure circumstances.
8. Final and additional provisions.

In addition to the contract manufacturing agreement, a quality agreement is concluded between the parties, which specifies the requirements applicable to the partner’s quality management system, and also determines the rights and obligations of the parties regarding the medicinal product or medical device that is planned to be manufactured and supplied. The quality agreement does not reflect the general rules for concluding a contract, such as, for example, confidential information, however, it clearly spells out the obligations of the parties to the agreement related to the main quality parameters, including the supply of products and materials for contract manufacturing. The quality agreement in most cases contains the following sections:

1. Terms and Definitions. This section is necessary so that the customer and the contractor clearly agree on the basic concepts used in the agreement.
2. Scope. Reflects the specifics of the provided production services under the contract.
3. Dispute resolution.
4. Production activity. Production processes, their control, equipment, premises, quality control, materials for contract manufacturing, laboratory control, etc. are described.

Due to the changing economic and political situation, in addition to the above sections, the quality agreement may reflect the provisions for changes, in which case the contractor and the customer may initiate changes in processes, equipment, laboratory control and other contractual requirements. At the same time, the quality agreement should reflect the right of the client company to audit the activities transferred to the executing company.

The possible risks, the responsibility of the parties, the profit received, etc. depend on the careful study of the texts of the documents to be drawn up in the course of contract manufacturing. In this regard, the development of texts by an experienced lawyer will minimize financial and time resources and reduce possible risks.

Legal services

1. Legal advice on contract manufacturing of medicines and medical devices
2. Legal support in the preparation of contract manufacturing of medicines and medical devices
3. Legal analysis of possible risks in the implementation of contract manufacturing of medicines and medical devices
4. Preparation of a contract, quality agreement and other documents required for contract manufacturing of medicines and medical devices
5. Representation of interests in legal interaction on contract manufacturing issues with a partner company