Contract manufacturing in the pharmaceutical industry is a process whereby a company (the contract manufacturer) produces drugs or other medical devices on behalf of another company (the customer). This is common practice in the pharmaceutical industry, allowing companies to focus on research and development, while manufacturing and processing is carried out by specialized companies. A contract manufacturer can also be commissioned if the company’s own production capacities are exhausted.

The important aspects of contract manufacturing (German translation: Lohnherstellung) within the framework of GMP regulations include:

• Quality and compliance with GMP guidelines: Contract manufacturers must fulfill all GMP requirements to ensure product quality and safety. This includes proper quality management, control of manufacturing processes, validation of equipment and methods.
• Responsibilities and documentation: The responsibilities of both the contract manufacturer and the customer must be clearly defined. It is mandatory that detailed documentation including product specifications, manufacturing and quality control procedures be maintained.
• Audits and inspections: The customer has the right to conduct audits and inspections at the production site of the contract manufacturer in order to confirm compliance with GMP guidelines and other legal regulations.
• Proof of quality: The contract manufacturer must ensure that all product batches meet the specified quality standards before release (German: Freigabe).
• Change management: Any changes to the production process or product composition must be approved by both parties and comply with legal requirements.
• Securing the supply chain: The contract manufacturer must ensure that the supply chains of the raw materials used for production are secure and transparent, and that only raw materials that meet pharmacopoeia requirements are used.
• Risk management: The risks associated with contract manufacturing should be identified and minimized to ensure product quality and compliance with legal requirements.
• Confidentiality and data protection: Maintaining the confidentiality (translation into German: Vertraulichkeit) of the customers’ commercial and technical information.
• Continuous improvement: Contract manufacturers should strive to continuously improve processes and quality systems.
• Staff training: The contract manufacturer’s staff must be regularly trained in accordance with GMP principles.

These aspects help to ensure that the drugs produced by contract manufacturers are safe and effective and meet the specified quality standards. If the responsibilities, rights and obligations are clearly defined, contract manufacturing can be financially beneficial to both parties.

Let our language professionals take care of the pharmaceutical translation of your pharmaceutical documents (inspection reports, SOPs, etc.) and accompany you as pharmaceutical interpreters during GMP inspections by foreign authorities.