GLP Tox Lot Manufacturing

​​​​​​​GLP Manufacturing of parenteral products for preclinical studies.

GLP (Good Laboratory Practice) manufacturing refers to the production of parenteral products (such as injectable drugs) in accordance with good laboratory practices. GLP manufacturing is typically performed in support of preclinical studies, which are conducted to evaluate the safety and effectiveness of a product prior to its clinical testing in humans.
GLP manufacturing is designed to ensure the consistency, quality, and reliability of parenteral products that are used in preclinical studies. It involves strict guidelines for the production, testing, and documentation of these products, including the use of appropriate facilities, equipment, and procedures.

To conduct GLP manufacturing of parenterals for preclinical studies, a company must have a well-defined quality management system in place that is designed to meet the requirements of GLP. This includes the use of standard operating procedures (SOPs) that outline the steps involved in the production, testing, and documentation of the product.

GLP manufacturing is an important part of the development and testing of parenteral products, and it is essential for ensuring the safety and effectiveness of these products. HTD has expertise in GLP manufacturing and can provide high-quality services to our clients to support the development of safe and effective products.

Aseptic Fill Finish of Lyophilized Products

HTD utilizes aseptic fill-finish, a process that is used to fill and package lyophilized (freeze-dried) products in a sterile environment to prevent contamination. Aseptic fill-finish is an important step in the manufacturing of lyophilized products, as it ensures the safety and effectiveness of the product.
The aseptic fill-finish process typically consists of several steps, including:
  1. Preparation of the lyophilized product: The lyophilized product is prepared for filling by reconstituting it with a sterile liquid, such as water for injection or a buffer solution.
  2. Filling: The reconstituted product is then transferred to a sterile filling machine and filled into sterile containers, such as vials or syringes.
  3. Sealing: The filled containers are then sealed to prevent contamination.
  4. Sterilization: The filled and sealed containers are then sterilized to ensure that they are free of contaminants. This is typically done using a sterilization process, such as gamma radiation or ethylene oxide gas sterilization.
  5. Packaging: The sterilized containers are then packaged in a sterile environment and labeled for distribution.